<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04491110</url>
  </required_header>
  <id_info>
    <org_study_id>AP-0225-2019</org_study_id>
    <nct_id>NCT04491110</nct_id>
  </id_info>
  <brief_title>Intervention to Improve Quality of Sleep of Palliative Patient Carers in the Community: Clinical Trial</brief_title>
  <acronym>IMECA</acronym>
  <official_title>Intervention to Improve Sleep Quality in Caregivers of Palliative Care Patients in the Community: Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Andaluz Health Service</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Andaluz Health Service</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction Sleeping problems experienced by cancer patients carers are frequent with 72% of&#xD;
      carers reporting moderate to severe problems. Another consequence for this carers is the&#xD;
      increase of suffering from depression and it is usually associated to carer overload.&#xD;
&#xD;
      Objectives&#xD;
&#xD;
      Main objective:&#xD;
&#xD;
      - To evaluate the effects of listening to music in sleep quality for oncology patients&#xD;
      non-professional carers at home, and to evaluate the influence of specific factors that may&#xD;
      modify that effect.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  To assess the relationship between the waking state and the consequences during the day&#xD;
           according to sleep characteristics. These include:&#xD;
&#xD;
           1. Psychological results:&#xD;
&#xD;
             1. Quality of life.&#xD;
&#xD;
             2. Carer overload.&#xD;
&#xD;
           2. Physical results:&#xD;
&#xD;
             1. Sleepiness during the day.&#xD;
&#xD;
             2. Physical activity, intensity and length evaluation.&#xD;
&#xD;
        -  To assess carers satisfaction with the intervention.&#xD;
&#xD;
      Method Randomized clinical trial, single blinding and performed in oncological patients&#xD;
      carers in several practices. 2 samples of 40 carers. Intervention group will be taken through&#xD;
      a seven session intervention with music; control group will undergo seven sessions of&#xD;
      therapeutic education (as a reminder). Results will be evaluated using Pittsburgh Quality of&#xD;
      Sleep Index, triaxial accelerometer, EuroQol-5D-5L, Caregiver Strain Index, Epworth&#xD;
      Sleepiness Scale and Client Satisfaction Questionnaire.&#xD;
&#xD;
      Statistical analysis Basal values will be compared for both groups. Then the values before&#xD;
      and after the intervention will be compared using Student's t distribution for normal&#xD;
      continuous variables, and Wilcoxon's T test for paired data in continuous not normal&#xD;
      variables. A multiple linear regression will be carried out.&#xD;
&#xD;
      The system developed for the PREDIMEDPLUS study will be used to process accelerometer data&#xD;
      results. This semi-automated system manages data capture in a continuous stream in a central&#xD;
      server of Malaga University. Processing and analysis of this data is also centralised, with&#xD;
      an open source package, GGIR v. 1.5-1248&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND AND CURRENT STATUS&#xD;
&#xD;
      Sleep is a complex vital process in which humans spend a third of our lives. Insomnia is&#xD;
      related to discontent with quality, length or continuity in that sleep, usually seen as&#xD;
      problems to fall sleep, waking up frequently or a sleep that doesn't leave us rested.&#xD;
      Progressive shortening on sleep length is a risk factor on developing obesity, diabetes,&#xD;
      hypertension, cardiac related conditions and cerebrovascular accident, and can lead to&#xD;
      premature death.&#xD;
&#xD;
      Insomnia affects work performance: in severe cases it may lead to a reduction in care or&#xD;
      reflexes, increased risk of being involved in accidents, poor morale or social relationships,&#xD;
      absence from work and quality of life and immunity reduction.&#xD;
&#xD;
      Regarding sleep decrease in informal carers it is observed that during the condition progress&#xD;
      there are several changes in the patients. These changes are related to an increase on sleep&#xD;
      alterations in carers, with a mayor prevalence (42 to 95%) in carers of patients with late&#xD;
      stage cancer, compared to early stage patients carer (36 to 80%).&#xD;
&#xD;
      Another aspect that may be overlooked frequently is physical activity conducted by carers as&#xD;
      a health preventive measure, due to the benefits that physical exercise reports on the health&#xD;
      and well-being, including a reduction on risk factors for cardiovascular diseases, cancer,&#xD;
      stress and depression reduction, carer overload, mental and cognitive health, and general&#xD;
      well-being. Sleep quality improves when physical activity increases in carers.&#xD;
&#xD;
      Insomnia treatment is currently based in pharmaceutical treatment, including sedatives and&#xD;
      hypnotic drugs which can provoke dependency and tolerance, reducing their efficacy. These&#xD;
      drugs can induce cognitive and behavioural changes, and can lead to severe if not uncommon&#xD;
      consequences. Other non-drug related treatments have been developed to deal with insomnia,&#xD;
      including music therapy as this induces emotional responses in people. These responses are&#xD;
      classified according to good or bad, and also in their intensity, being high or low.&#xD;
&#xD;
      Several theories have tried to explain how our brain processes emotions. One of them is the&#xD;
      classic subcortical route in which our limbic system plays a fundamental role. The type of&#xD;
      melody influences recognition as happy or sad, and this recognition happens thanks to the&#xD;
      inferior frontal gyrus, midline nuclear group and the anterior cingulate cortex.&#xD;
&#xD;
      Music capacity to produce such an intense pleasure and the stimulation it provides to the&#xD;
      endogenous rewarding systems suggest that, if not essential, music it is still a great&#xD;
      benefit for our mental and physical well-being.&#xD;
&#xD;
      A Cochrane review of 2015 evaluated the effects on listening to music for adults who suffered&#xD;
      insomnia. 5 studies were included in the analysis (N = 264) to provide data about sleep&#xD;
      quality on Pittsburgh Index, with results proving a benefit on listening to music. The effect&#xD;
      was an increase in quality of sleep approximate to a standard deviation compared to no&#xD;
      treatment or standard treatments. Only one study (N = 50, low quality evidence) showed data&#xD;
      regarding latency at the beginning of the sleep cycle, total sleep time, sleep interruption&#xD;
      and sleep efficacy. However it didn't show any evidence of improvement thanks to the music&#xD;
      intervention. Authors concluded music can be effective to improve subjective quality of sleep&#xD;
      in adults with insomnia. The intervention is safe and easy to administered, but more research&#xD;
      is required to stablish the effects on other variables, as well as daytime consequences of&#xD;
      insomnia.&#xD;
&#xD;
      A systematic review in 2018 regarding the possibility that music can improve quality of sleep&#xD;
      in primary insomnia adults concluded that the improvement is only present with the relaxation&#xD;
      that is associated to music, compared to the normal state of the patients.&#xD;
&#xD;
      This research is justified with the goal of evaluation in an objective way the quality of&#xD;
      sleep in carers using the accelerometer, as well as subjective measures related to how&#xD;
      listening to music can affect other sleeps variables (sleep interruptions, quality, total&#xD;
      time, daytime consequences). The Cochrane review showed poor ratings of evidence in these&#xD;
      variables except for quality of sleep being medium, as they were evaluated only in one study.&#xD;
      High rating research is required to determine and establish the effect on daytime activity,&#xD;
      which is why this clinical trial will take into account the authors recommendations to avoid&#xD;
      bias. The use of the accelerometer will also provide data on physical activity in carers&#xD;
      setting the ground for an intervention in the field.&#xD;
&#xD;
      Objectives&#xD;
&#xD;
      Main objective:&#xD;
&#xD;
      - To evaluate the effects of listening to music in sleep quality for oncology patients&#xD;
      non-professional carers at home, and to evaluate the influence of specific factors that may&#xD;
      modify that effect.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  To assess the relationship between the waking state and the consequences during the day&#xD;
           according to sleep characteristics. These include:&#xD;
&#xD;
           3. Psychological results:&#xD;
&#xD;
           1. Quality of life. 2. Carer overload. 4. Physical results:&#xD;
&#xD;
             1. Sleepiness during the day.&#xD;
&#xD;
             2. Physical activity, intensity and length evaluation.&#xD;
&#xD;
        -  To assess carers satisfaction with the intervention.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      Randomised clinical trail, single blinding carried out in several practices in the field of&#xD;
      Primary Care of 6 units of Clinical Management belonging to the Malaga-Guadalhorce Health&#xD;
      District, with informal carers of domiciliary oncological palliative patients.&#xD;
&#xD;
      Subject recruitment will be randomised and performed using a list of random numbers obtained&#xD;
      using the program Epidat 3.1. This sample will take the oncological patients included in the&#xD;
      Palliative Care Assistance Procedure showed on the Digital Clinical Records (DIRAYA) and&#xD;
      having an informal care; every carer will be contacted and evaluated to the inclusion&#xD;
      criteria, offering the possibility on taking part of the study if agreed and providing an&#xD;
      informative leaflet. If accepted, a consent must be signed.&#xD;
&#xD;
      Randomising method will be as followed: several cards will be prepared labelled with &quot;you&#xD;
      have been included in the intervention group&quot; or &quot;you have been included in the control&#xD;
      group&quot;, making equal numbers for the groups. They will be sealed on non-transparent&#xD;
      envelopes, will be mixed and numbered after shuffling. The participants will be given a&#xD;
      number (in order of acceptance to take part) and that number will be the assigned envelope&#xD;
      and the group it contains. This procedure makes bias harder to occur.&#xD;
&#xD;
      Carers are offered the different groups and classified in intervention or control group, and&#xD;
      this procedure it's performed by a sole person who will be responsible for randomising.&#xD;
&#xD;
      Once the researcher in charge of randomising knows the group the carer belongs to, he will&#xD;
      proceed to inform them of the procedure the participants will be subject to without&#xD;
      mentioning if they are intervention or control group so the patient will be oblivious.&#xD;
&#xD;
      This researcher will also inform the patient on how to use the accelerometer, the music&#xD;
      program Spotify (Premium version) or the audio file through Google Drive (intervention or&#xD;
      control group respectively).&#xD;
&#xD;
      Sample size: Based on data published by Jespersen et al. 201543 about quality of sleep the&#xD;
      researchers are expecting to find an equivalent effect of medium standard differences of&#xD;
      0,776, with an alpha error of 0,05 and a beta error of 0,10. The sample size will be two&#xD;
      groups of 35 patients (Epidat 3.1) increased to 40 to compensate for possible&#xD;
      droppings/leaving.&#xD;
&#xD;
      Procedure for each group:&#xD;
&#xD;
        -  Control group: The treatment will be performed according to what it is established in&#xD;
           the Andalusian Palliative Care plan from the Health Council regarding carers, which&#xD;
           include a complete initial evaluation regarding the 14 needs of Virginia Henderson, and&#xD;
           the subsequent care plan and follow-up for problems or symptoms check; a basic health&#xD;
           education for self-care and patient care will be administered, regarding feeding and&#xD;
           hydration, physical exercise and leisure, medication, effective communication, skin&#xD;
           care, prevention and treatment of constipation, and sleep hygiene. Carers from the&#xD;
           control group will also receive the conventional health education that the carers will&#xD;
           need to listen through headphones/earphones in the morning, using the mobile phone and&#xD;
           the audio file shared in Google Drive, in daily sessions of 30 minutes during 7 days,&#xD;
           while also wearing the accelerometer a week before and the week of the intervention.&#xD;
           This way the caseload management nursing staff will be blinded on patient evaluation&#xD;
           (see Masking and Randomising).&#xD;
&#xD;
        -  Intervention group: carers will receive conventional health assistance complemented with&#xD;
           music therapy with preselected music according to carers personal choice. The&#xD;
           participants will have to listen to it half an hour before going to bed. The chosen&#xD;
           music must be music that produces them pleasure or a nice feeling. This will be listened&#xD;
           to via headphones/earphones and the mobile app Spotify (Premium version with free month&#xD;
           trial). Daily session of 30 minutes during 7 days and the participants will wear the&#xD;
           accelerometer the week before and the week of the intervention.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      A descriptive study will be performed with the collected variable using the medium and&#xD;
      standard deviation in continuous normal variables, the confidence interval in punctual&#xD;
      estimations; median and interquartile range in non-normal continuous variables, and frequency&#xD;
      and percentages in categorical variables. The adjustment to normality will be determined with&#xD;
      the Shapiro-Wilk test.&#xD;
&#xD;
      The basal values of both groups will be compared. Pre and post-intervention values will be&#xD;
      analysed in both groups using the Student's t distribution for normal continuous variables&#xD;
      and Wilcoxon's T for paired data in non-normal continuous variables. A multiple lineal&#xD;
      regression will be also carried out where the dependant variable will be: self-perceived&#xD;
      quality of sleep, total sleep time, total resting time, sleep interruption, sleep efficiency,&#xD;
      quality of life, carer overload, daytime sleepiness, physical activity, intensity and length.&#xD;
      The independent variables will be the intervention ones and the socio-demographic such as&#xD;
      sex, age, education level, civil status, time dedicated to care, help received in care, time&#xD;
      that the participants have been taking care of the patient, and relationship to person care&#xD;
      for. The analysis will be similar for the use of painkillers, anxiolytic and sleeping pill&#xD;
      medication.&#xD;
&#xD;
      The system developed for the PREDIMEDPLUS study will be used to process accelerometer data&#xD;
      results. Processing and analysis of this data is also centralised, with an open source&#xD;
      package, GGIR v. 1.5-1248 If statistically significant data are obtained in normal variables,&#xD;
      the confidence intervals will be calculated at 95% to estimate values for the differences&#xD;
      between the variables. The software to be used will be SPSS 23.0 and Epidat 3.01. Confidence&#xD;
      interval will be 95% meaning only p values below 0,05 will be considered as statistically&#xD;
      significant.&#xD;
&#xD;
      The present studio adjusts to the ethical recommendations:&#xD;
&#xD;
      1975 Helsinki Accords revised in 2013 (Ethical principles for research in humans (Helsinki,&#xD;
      Adapted by the 64th General Assembly, Fortaleza, Brasil, October 2013).&#xD;
&#xD;
      All the personal information obtained in this study are confidential and will be dealt with&#xD;
      in agreement to the EU 2016/679 regulation and the 27th of April 2016 GDPR (General Data&#xD;
      Protection Regulation).&#xD;
&#xD;
      The 14th November 41/2002 law regulates the patient's autonomy and all the rights and duties&#xD;
      regarding information and clinical records.&#xD;
&#xD;
      All the personal information collected in this study are confidential and will be treated in&#xD;
      agreement with the 5th December 3/2018 Organic Law of Personal Data Protection and digital&#xD;
      rights guarantee.&#xD;
&#xD;
      Participation is fully voluntary and an Informed consent will be signed to be admitted into&#xD;
      the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">March 15, 2022</completion_date>
  <primary_completion_date type="Actual">February 12, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>The masking is performed by assigning a mobile phone with headphones and an accelerometer to the carers of the control and intervention group and with the instruction not to mention what they heard to the evaluator; in this sense the participants do not know if they belong to the control or intervention group. However those who listen to music can conclude that it is an intervention group by themselves.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline quality of self-perceived sleep at 7 days through The Pittsburgh Sleep Quality Index (PSQI).</measure>
    <time_frame>Pre-intervention/Post-intervention (0 and 7 days)</time_frame>
    <description>Validated into Spanish. It values the sleep quality perceived by the subject. 7 different scores are obtained from the result, granting information for several components of the sleep quality: subjective quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances (frequency of coughs, snores, heat, cold), sleeping pills intake, diurnal dysfunction (faculty to fall asleep through an activity because of tiredness). The sum of the scores in each component will be included into a Total Score (TS) from 0 to 21. According to Buysse and Cols, a TS of 5 will be the cutting point between a good and a bad sleep quality, less than 5 will show the presence of good sleep quality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline total sleep time and rest time (nighttime sleep and daytime rest / naps) at 7 days by accelerometry</measure>
    <time_frame>Preintervention/Postintervention (0 and 7 days)</time_frame>
    <description>The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline sleep interruption level (number of awakenings and wakefulness after the onset of sleep) at 7 days by accelerometry</measure>
    <time_frame>Preintervention/Postintervention ( 0 and 7 days)</time_frame>
    <description>The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline sleep efﬁciency (percentage of time in bed sleeping) (at the beginning and at 7 days) at 7 days by accelerometry.</measure>
    <time_frame>Preintervention/Postintervention ( 0 and 7 days)</time_frame>
    <description>The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline levels of intensity of daily physical activity at 7 days by accelerometry.</measure>
    <time_frame>Preintervention/Postintervention ( 0 and 7 days)</time_frame>
    <description>The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline daytime sleepiness at 7 days through the Epworth Sleepiness Scale (ESS).</measure>
    <time_frame>Preintervention/Postintervention ( 0 and 7 days)</time_frame>
    <description>Self-administered scale to measure diurnal sleepiness with 8 questions, scoring from 0 to 3 for a maximum score of 24. This scale is validated in Spanish.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline caregiver's effort index at 7 days through The Caregiver Strain Index Questionnaire (CSI)</measure>
    <time_frame>Preintervention/Postintervention ( 0 and 7 days)</time_frame>
    <description>Aimed to be answered by the caregiver of dependent people, containing 13 items with True/False answer. Every positive answer scores for 1. If the total is higher or equal to 7 it indicates a high level of strain. Being validated in Spanish, this is the scale used to evaluate the emotional and physical situation of the caregiver regarding their need to take care of a person in palliative care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline quality of life of the caregiver at 7 days through the EuroQol-5D-5L.</measure>
    <time_frame>Preintervention/Postintervention ( 0 and 7 days)</time_frame>
    <description>questionnaire validated in Spanish will be used, which describes health condition in 5 dimensions (mobility, personal care, day-to-day activities, pain/discomfort and anxiety/depression). It also present a visual analogue scale (VAS) graded 0 to 100 with the inserts &quot;worst conceivable health condition&quot; and &quot;best conceivable health condition&quot; in 0 and 100 respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Satisfaction Questionnaire (CSQ-8)</measure>
    <time_frame>Postintervention (7 days)</time_frame>
    <description>8 questions answered through a Likert-type scale of 4 points and self-administered, with specific points to each item. The categories would be as follows: quality of the service, type of services, results and general satisfaction. It will include 3 open questions where the subjects answer what they liked most from the treatment, what they liked less, and what they would change. This tool has been proved to determine patient´s satisfaction with high reliability and coherence, being validated in the 8 items versions for Spanish speakers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Socio-demographic carers data</measure>
    <time_frame>Preintervention (0 days)</time_frame>
    <description>: age, sex, civil status, education level, out-of-house job, time dedicated to care, help&#xD;
received for care, time that they have been taking care of someone, time the patient has&#xD;
been under palliative care, relationship with the patient, and consumption of painkillers, anxiolytic and sleeping pills medication.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Music Therapy</condition>
  <condition>Caregivers</condition>
  <condition>Sleep</condition>
  <condition>Palliative Care</condition>
  <arm_group>
    <arm_group_label>Experimental: Carer music.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Listening to pre-recorded and selected music preferred by the carer, half an hour for 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Comparator: Carer.</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Basic therapeutic education repetition performed to all carer through earphones, half an hour for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music Therapy</intervention_name>
    <description>We are aiming to use music therapy, with pre-recorded favoured music, as a complementary treatment in oncological patients in palliative care, as well as on the carer. It will be done by using mobile telephones.</description>
    <arm_group_label>Experimental: Carer music.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>simulation with therapeutic education</intervention_name>
    <description>Basic therapeutic education repetition performed to all caregivers and oncological patients in palliative care, through mobile phones.</description>
    <arm_group_label>Sham Comparator: Carer.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being informal carer of a domiciliary palliative care patient.&#xD;
&#xD;
          -  Having given informed consent to take part in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Informal carer with severe hypoacusia, making it difficult to listen to the music on&#xD;
             the phone/use of headphones&#xD;
&#xD;
          -  Informal carer allergic to plastic and/or metal&#xD;
&#xD;
          -  Informal carer with a programmed trip in the 2 weeks the study takes place&#xD;
&#xD;
          -  Informal carer without mobile phone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Inmaculada Valero Cantero, Nurse</last_name>
    <role>Principal Investigator</role>
    <affiliation>Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud</affiliation>
  </overall_official>
  <overall_official>
    <last_name>María Angeles Vázquez Sanchez, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>University of Malaga</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yolanda Carrión Velasco, Nurse</last_name>
    <role>Study Chair</role>
    <affiliation>Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Milagrosa Espinar Toledo, Nurse</last_name>
    <role>Study Chair</role>
    <affiliation>Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cristina Casals Sánchez, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>University od Cádiz</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Librado Valverde Velasco, Nurse</last_name>
    <role>Study Chair</role>
    <affiliation>Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Milagros Reyes Sánchez, Nurse</last_name>
    <role>Study Chair</role>
    <affiliation>Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nuria Garcia-Agua Soler, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>University of Malaga</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francisco Martínez Valero, chiropodist</last_name>
    <role>Study Chair</role>
    <affiliation>National Health Service and Midlothian Foot Care, Dalkeith, Lothian, Scotland.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francisco Javier Barón López, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>University of Malaga</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jose Luís Casals Sánchez, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Universitario Virgen de la Victoria de Málaga</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ana Belén Arrabal Téllez, Nurse</last_name>
    <role>Study Chair</role>
    <affiliation>Distrito Sanitario Axarquía-Este. Servicio Andaluz de Salud</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rosa Ana Serrano Benavente, doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Distrito Sanitario Axarquía-Este.Servicio Andaluz de Salud</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Julia Wárnberg W, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>University of Malaga</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inmaculada Valero Cantero</name>
      <address>
        <city>Málaga</city>
        <zip>29014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.who.int/dietphysicalactivity/publications/9789241599979/en/</url>
    <description>World Health Organization. Global Recommendations on Physical Activity for Health. [Libro en Internet] Génova (Suiza). OMS; 2010. [acceso 25 de marzo de 2018].</description>
  </link>
  <link>
    <url>https://www.juntadeandalucia.es/organismos/saludyfamilias/areas/planificacion/planes-integrales/paginas/pacpa.html</url>
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  </link>
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  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>March 16, 2022</last_update_submitted>
  <last_update_submitted_qc>March 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Andaluz Health Service</investigator_affiliation>
    <investigator_full_name>Francisco Javier Navarro Moya</investigator_full_name>
    <investigator_title>BSc Nursing</investigator_title>
  </responsible_party>
  <keyword>Sleep</keyword>
  <keyword>Caregivers</keyword>
  <keyword>Music Therapy</keyword>
  <keyword>Palliative Care</keyword>
  <keyword>Nurses</keyword>
  <keyword>Exercise</keyword>
  <keyword>Physical Exertion</keyword>
  <pending_results>
    <submitted>March 30, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04491110
org study id: AP-0225-2019
nct id: NCT04491110
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction Sleeping problems experienced by cancer patients carers are frequent with 72% of
      carers reporting moderate to severe problems. Another consequence for this carers is the
      increase of suffering from depression and it is usually associated to carer overload.

      Objectives

      Main objective:

      - To evaluate the effects of listening to music in sleep quality for oncology patients
      non-professional carers at home, and to evaluate the influence of specific factors that may
      modify that effect.

      Secondary objectives:

        -  To assess the relationship between the waking state and the consequences during the day
           according to sleep characteristics. These include:

           1. Psychological results:

             1. Quality of life.

             2. Carer overload.

           2. Physical results:

             1. Sleepiness during the day.

             2. Physical activity, intensity and length evaluation.

        -  To assess carers satisfaction with the intervention.

      Method Randomized clinical trial, single blinding and performed in oncological patients
      carers in several practices. 2 samples of 40 carers. Intervention group will be taken through
      a seven session intervention with music; control group will undergo seven sessions of
      therapeutic education (as a reminder). Results will be evaluated using Pittsburgh Quality of
      Sleep Index, triaxial accelerometer, EuroQol-5D-5L, Caregiver Strain Index, Epworth
      Sleepiness Scale and Client Satisfaction Questionnaire.

      Statistical analysis Basal values will be compared for both groups. Then the values before
      and after the intervention will be compared using Student's t distribution for normal
      continuous variables, and Wilcoxon's T test for paired data in continuous not normal
      variables. A multiple linear regression will be carried out.

      The system developed for the PREDIMEDPLUS study will be used to process accelerometer data
      results. This semi-automated system manages data capture in a continuous stream in a central
      server of Malaga University. Processing and analysis of this data is also centralised, with
      an open source package, GGIR v. 1.5-1248
BACKGROUND AND CURRENT STATUS

      Sleep is a complex vital process in which humans spend a third of our lives. Insomnia is
      related to discontent with quality, length or continuity in that sleep, usually seen as
      problems to fall sleep, waking up frequently or a sleep that doesn't leave us rested.
      Progressive shortening on sleep length is a risk factor on developing obesity, diabetes,
      hypertension, cardiac related conditions and cerebrovascular accident, and can lead to
      premature death.

      Insomnia affects work performance: in severe cases it may lead to a reduction in care or
      reflexes, increased risk of being involved in accidents, poor morale or social relationships,
      absence from work and quality of life and immunity reduction.

      Regarding sleep decrease in informal carers it is observed that during the condition progress
      there are several changes in the patients. These changes are related to an increase on sleep
      alterations in carers, with a mayor prevalence (42 to 95%) in carers of patients with late
      stage cancer, compared to early stage patients carer (36 to 80%).

      Another aspect that may be overlooked frequently is physical activity conducted by carers as
      a health preventive measure, due to the benefits that physical exercise reports on the health
      and well-being, including a reduction on risk factors for cardiovascular diseases, cancer,
      stress and depression reduction, carer overload, mental and cognitive health, and general
      well-being. Sleep quality improves when physical activity increases in carers.

      Insomnia treatment is currently based in pharmaceutical treatment, including sedatives and
      hypnotic drugs which can provoke dependency and tolerance, reducing their efficacy. These
      drugs can induce cognitive and behavioural changes, and can lead to severe if not uncommon
      consequences. Other non-drug related treatments have been developed to deal with insomnia,
      including music therapy as this induces emotional responses in people. These responses are
      classified according to good or bad, and also in their intensity, being high or low.

      Several theories have tried to explain how our brain processes emotions. One of them is the
      classic subcortical route in which our limbic system plays a fundamental role. The type of
      melody influences recognition as happy or sad, and this recognition happens thanks to the
      inferior frontal gyrus, midline nuclear group and the anterior cingulate cortex.

      Music capacity to produce such an intense pleasure and the stimulation it provides to the
      endogenous rewarding systems suggest that, if not essential, music it is still a great
      benefit for our mental and physical well-being.

      A Cochrane review of 2015 evaluated the effects on listening to music for adults who suffered
      insomnia. 5 studies were included in the analysis (N = 264) to provide data about sleep
      quality on Pittsburgh Index, with results proving a benefit on listening to music. The effect
      was an increase in quality of sleep approximate to a standard deviation compared to no
      treatment or standard treatments. Only one study (N = 50, low quality evidence) showed data
      regarding latency at the beginning of the sleep cycle, total sleep time, sleep interruption
      and sleep efficacy. However it didn't show any evidence of improvement thanks to the music
      intervention. Authors concluded music can be effective to improve subjective quality of sleep
      in adults with insomnia. The intervention is safe and easy to administered, but more research
      is required to stablish the effects on other variables, as well as daytime consequences of
      insomnia.

      A systematic review in 2018 regarding the possibility that music can improve quality of sleep
      in primary insomnia adults concluded that the improvement is only present with the relaxation
      that is associated to music, compared to the normal state of the patients.

      This research is justified with the goal of evaluation in an objective way the quality of
      sleep in carers using the accelerometer, as well as subjective measures related to how
      listening to music can affect other sleeps variables (sleep interruptions, quality, total
      time, daytime consequences). The Cochrane review showed poor ratings of evidence in these
      variables except for quality of sleep being medium, as they were evaluated only in one study.
      High rating research is required to determine and establish the effect on daytime activity,
      which is why this clinical trial will take into account the authors recommendations to avoid
      bias. The use of the accelerometer will also provide data on physical activity in carers
      setting the ground for an intervention in the field.

      Objectives

      Main objective:

      - To evaluate the effects of listening to music in sleep quality for oncology patients
      non-professional carers at home, and to evaluate the influence of specific factors that may
      modify that effect.

      Secondary objectives:

        -  To assess the relationship between the waking state and the consequences during the day
           according to sleep characteristics. These include:

           3. Psychological results:

           1. Quality of life. 2. Carer overload. 4. Physical results:

             1. Sleepiness during the day.

             2. Physical activity, intensity and length evaluation.

        -  To assess carers satisfaction with the intervention.

      Method:

      Randomised clinical trail, single blinding carried out in several practices in the field of
      Primary Care of 6 units of Clinical Management belonging to the Malaga-Guadalhorce Health
      District, with informal carers of domiciliary oncological palliative patients.

      Subject recruitment will be randomised and performed using a list of random numbers obtained
      using the program Epidat 3.1. This sample will take the oncological patients included in the
      Palliative Care Assistance Procedure showed on the Digital Clinical Records (DIRAYA) and
      having an informal care; every carer will be contacted and evaluated to the inclusion
      criteria, offering the possibility on taking part of the study if agreed and providing an
      informative leaflet. If accepted, a consent must be signed.

      Randomising method will be as followed: several cards will be prepared labelled with "you
      have been included in the intervention group" or "you have been included in the control
      group", making equal numbers for the groups. They will be sealed on non-transparent
      envelopes, will be mixed and numbered after shuffling. The participants will be given a
      number (in order of acceptance to take part) and that number will be the assigned envelope
      and the group it contains. This procedure makes bias harder to occur.

      Carers are offered the different groups and classified in intervention or control group, and
      this procedure it's performed by a sole person who will be responsible for randomising.

      Once the researcher in charge of randomising knows the group the carer belongs to, he will
      proceed to inform them of the procedure the participants will be subject to without
      mentioning if they are intervention or control group so the patient will be oblivious.

      This researcher will also inform the patient on how to use the accelerometer, the music
      program Spotify (Premium version) or the audio file through Google Drive (intervention or
      control group respectively).

      Sample size: Based on data published by Jespersen et al. 201543 about quality of sleep the
      researchers are expecting to find an equivalent effect of medium standard differences of
      0,776, with an alpha error of 0,05 and a beta error of 0,10. The sample size will be two
      groups of 35 patients (Epidat 3.1) increased to 40 to compensate for possible
      droppings/leaving.

      Procedure for each group:

        -  Control group: The treatment will be performed according to what it is established in
           the Andalusian Palliative Care plan from the Health Council regarding carers, which
           include a complete initial evaluation regarding the 14 needs of Virginia Henderson, and
           the subsequent care plan and follow-up for problems or symptoms check; a basic health
           education for self-care and patient care will be administered, regarding feeding and
           hydration, physical exercise and leisure, medication, effective communication, skin
           care, prevention and treatment of constipation, and sleep hygiene. Carers from the
           control group will also receive the conventional health education that the carers will
           need to listen through headphones/earphones in the morning, using the mobile phone and
           the audio file shared in Google Drive, in daily sessions of 30 minutes during 7 days,
           while also wearing the accelerometer a week before and the week of the intervention.
           This way the caseload management nursing staff will be blinded on patient evaluation
           (see Masking and Randomising).

        -  Intervention group: carers will receive conventional health assistance complemented with
           music therapy with preselected music according to carers personal choice. The
           participants will have to listen to it half an hour before going to bed. The chosen
           music must be music that produces them pleasure or a nice feeling. This will be listened
           to via headphones/earphones and the mobile app Spotify (Premium version with free month
           trial). Daily session of 30 minutes during 7 days and the participants will wear the
           accelerometer the week before and the week of the intervention.

      Statistical analysis:

      A descriptive study will be performed with the collected variable using the medium and
      standard deviation in continuous normal variables, the confidence interval in punctual
      estimations; median and interquartile range in non-normal continuous variables, and frequency
      and percentages in categorical variables. The adjustment to normality will be determined with
      the Shapiro-Wilk test.

      The basal values of both groups will be compared. Pre and post-intervention values will be
      analysed in both groups using the Student's t distribution for normal continuous variables
      and Wilcoxon's T for paired data in non-normal continuous variables. A multiple lineal
      regression will be also carried out where the dependant variable will be: self-perceived
      quality of sleep, total sleep time, total resting time, sleep interruption, sleep efficiency,
      quality of life, carer overload, daytime sleepiness, physical activity, intensity and length.
      The independent variables will be the intervention ones and the socio-demographic such as
      sex, age, education level, civil status, time dedicated to care, help received in care, time
      that the participants have been taking care of the patient, and relationship to person care
      for. The analysis will be similar for the use of painkillers, anxiolytic and sleeping pill
      medication.

      The system developed for the PREDIMEDPLUS study will be used to process accelerometer data
      results. Processing and analysis of this data is also centralised, with an open source
      package, GGIR v. 1.5-1248 If statistically significant data are obtained in normal variables,
      the confidence intervals will be calculated at 95% to estimate values for the differences
      between the variables. The software to be used will be SPSS 23.0 and Epidat 3.01. Confidence
      interval will be 95% meaning only p values below 0,05 will be considered as statistically
      significant.

      The present studio adjusts to the ethical recommendations:

      1975 Helsinki Accords revised in 2013 (Ethical principles for research in humans (Helsinki,
      Adapted by the 64th General Assembly, Fortaleza, Brasil, October 2013).

      All the personal information obtained in this study are confidential and will be dealt with
      in agreement to the EU 2016/679 regulation and the 27th of April 2016 GDPR (General Data
      Protection Regulation).

      The 14th November 41/2002 law regulates the patient's autonomy and all the rights and duties
      regarding information and clinical records.

      All the personal information collected in this study are confidential and will be treated in
      agreement with the 5th December 3/2018 Organic Law of Personal Data Protection and digital
      rights guarantee.

      Participation is fully voluntary and an Informed consent will be signed to be admitted into
      the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Care Provider)
masking description: The masking is performed by assigning a mobile phone with headphones and an accelerometer to the carers of the control and intervention group and with the instruction not to mention what they heard to the evaluator; in this sense the participants do not know if they belong to the control or intervention group. However those who listen to music can conclude that it is an intervention group by themselves.
measure: Change from baseline quality of self-perceived sleep at 7 days through The Pittsburgh Sleep Quality Index (PSQI).
time frame: Pre-intervention/Post-intervention (0 and 7 days)
description: Validated into Spanish. It values the sleep quality perceived by the subject. 7 different scores are obtained from the result, granting information for several components of the sleep quality: subjective quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances (frequency of coughs, snores, heat, cold), sleeping pills intake, diurnal dysfunction (faculty to fall asleep through an activity because of tiredness). The sum of the scores in each component will be included into a Total Score (TS) from 0 to 21. According to Buysse and Cols, a TS of 5 will be the cutting point between a good and a bad sleep quality, less than 5 will show the presence of good sleep quality.
measure: Change from baseline total sleep time and rest time (nighttime sleep and daytime rest / naps) at 7 days by accelerometry
time frame: Preintervention/Postintervention (0 and 7 days)
description: The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.
measure: Change from baseline sleep interruption level (number of awakenings and wakefulness after the onset of sleep) at 7 days by accelerometry
time frame: Preintervention/Postintervention ( 0 and 7 days)
description: The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.
measure: Change from baseline sleep efﬁciency (percentage of time in bed sleeping) (at the beginning and at 7 days) at 7 days by accelerometry.
time frame: Preintervention/Postintervention ( 0 and 7 days)
description: The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.
measure: Change from baseline levels of intensity of daily physical activity at 7 days by accelerometry.
time frame: Preintervention/Postintervention ( 0 and 7 days)
description: The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.
measure: Change from baseline daytime sleepiness at 7 days through the Epworth Sleepiness Scale (ESS).
time frame: Preintervention/Postintervention ( 0 and 7 days)
description: Self-administered scale to measure diurnal sleepiness with 8 questions, scoring from 0 to 3 for a maximum score of 24. This scale is validated in Spanish.
measure: Change from baseline caregiver's effort index at 7 days through The Caregiver Strain Index Questionnaire (CSI)
time frame: Preintervention/Postintervention ( 0 and 7 days)
description: Aimed to be answered by the caregiver of dependent people, containing 13 items with True/False answer. Every positive answer scores for 1. If the total is higher or equal to 7 it indicates a high level of strain. Being validated in Spanish, this is the scale used to evaluate the emotional and physical situation of the caregiver regarding their need to take care of a person in palliative care.
measure: Change from baseline quality of life of the caregiver at 7 days through the EuroQol-5D-5L.
time frame: Preintervention/Postintervention ( 0 and 7 days)
description: questionnaire validated in Spanish will be used, which describes health condition in 5 dimensions (mobility, personal care, day-to-day activities, pain/discomfort and anxiety/depression). It also present a visual analogue scale (VAS) graded 0 to 100 with the inserts "worst conceivable health condition" and "best conceivable health condition" in 0 and 100 respectively.
measure: Client Satisfaction Questionnaire (CSQ-8)
time frame: Postintervention (7 days)
description: 8 questions answered through a Likert-type scale of 4 points and self-administered, with specific points to each item. The categories would be as follows: quality of the service, type of services, results and general satisfaction. It will include 3 open questions where the subjects answer what they liked most from the treatment, what they liked less, and what they would change. This tool has been proved to determine patient´s satisfaction with high reliability and coherence, being validated in the 8 items versions for Spanish speakers.
measure: Socio-demographic carers data
time frame: Preintervention (0 days)
description: : age, sex, civil status, education level, out-of-house job, time dedicated to care, help
received for care, time that they have been taking care of someone, time the patient has
been under palliative care, relationship with the patient, and consumption of painkillers, anxiolytic and sleeping pills medication.
arm group label: Experimental: Carer music.
arm group type: Experimental
description: Listening to pre-recorded and selected music preferred by the carer, half an hour for 7 days.
arm group label: Sham Comparator: Carer.
arm group type: Sham Comparator
description: Basic therapeutic education repetition performed to all carer through earphones, half an hour for 7 days.
intervention type: Other
intervention name: Music Therapy
description: We are aiming to use music therapy, with pre-recorded favoured music, as a complementary treatment in oncological patients in palliative care, as well as on the carer. It will be done by using mobile telephones.
arm group label: Experimental: Carer music.
intervention type: Other
intervention name: simulation with therapeutic education
description: Basic therapeutic education repetition performed to all caregivers and oncological patients in palliative care, through mobile phones.
arm group label: Sham Comparator: Carer.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Inmaculada Valero Cantero, Nurse
role: Principal Investigator
affiliation: Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud
last name: María Angeles Vázquez Sanchez, Doctor
role: Study Chair
affiliation: University of Malaga
last name: Yolanda Carrión Velasco, Nurse
role: Study Chair
affiliation: Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud
last name: Milagrosa Espinar Toledo, Nurse
role: Study Chair
affiliation: Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud
last name: Cristina Casals Sánchez, Doctor
role: Study Chair
affiliation: University od Cádiz
last name: Librado Valverde Velasco, Nurse
role: Study Chair
affiliation: Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud
last name: Milagros Reyes Sánchez, Nurse
role: Study Chair
affiliation: Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud
last name: Nuria Garcia-Agua Soler, Doctor
role: Study Chair
affiliation: University of Malaga
last name: Francisco Martínez Valero, chiropodist
role: Study Chair
affiliation: National Health Service and Midlothian Foot Care, Dalkeith, Lothian, Scotland.
last name: Francisco Javier Barón López, Doctor
role: Study Chair
affiliation: University of Malaga
last name: Jose Luís Casals Sánchez, Doctor
role: Study Chair
affiliation: Hospital Universitario Virgen de la Victoria de Málaga
last name: Ana Belén Arrabal Téllez, Nurse
role: Study Chair
affiliation: Distrito Sanitario Axarquía-Este. Servicio Andaluz de Salud
last name: Rosa Ana Serrano Benavente, doctor
role: Study Chair
affiliation: Distrito Sanitario Axarquía-Este.Servicio Andaluz de Salud
last name: Julia Wárnberg W, Doctor
role: Study Chair
affiliation: University of Malaga
facility: 
country: Spain
url: http://www.who.int/dietphysicalactivity/publications/9789241599979/en/
description: World Health Organization. Global Recommendations on Physical Activity for Health. [Libro en Internet] Génova (Suiza). OMS; 2010. [acceso 25 de marzo de 2018].
url: https://www.juntadeandalucia.es/organismos/saludyfamilias/areas/planificacion/planes-integrales/paginas/pacpa.html
description: Andalusian Palliative Care Plan
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responsible party type: Principal Investigator
investigator affiliation: Andaluz Health Service
investigator full name: Francisco Javier Navarro Moya
investigator title: BSc Nursing
submitted: March 30, 2023