xml: <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/NCT06024954</url>
    </required_header>
    <id_info>
      <org_study_id>EGE UNIVERSTY</org_study_id>
      <secondary_id>DUYGU AKBAŞ UYSAL</secondary_id>
      <nct_id>NCT06024954</nct_id>
    </id_info>
    <brief_title>Pain, Anxiety of Aromatherapy and Music Effect on</brief_title>
    <acronym>Palliative</acronym>
    <official_title>Palliative Care Pain, Anxiety and Vital Inhaler Effect of Aromatherapy Applied to Patients and Music Effect on Parameters</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ege University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ege University</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>
        The research is planned as a randomized controlled trial. The main question[s] it aims to&#xD;
        answer are:&#xD;
  &#xD;
        [question 1]: Does the inhaler effect of music and aromatherapy applied to palliative care&#xD;
        patients have an effect on pain, anxiety and vital signs?&#xD;
  &#xD;
        The individuals in the research group are divided into four groups as music group,&#xD;
        aromatherapy group, music and aromatherapy and control group. .&#xD;
  &#xD;
        Before and at the end of the intervention, data collection tools [Patient Description Form,&#xD;
        Visual analog scale,face anxiety scale, Distress Thermometer, Edmonton Symptom Scale] will&#xD;
        record the characteristics of pain, anxiety and vital parameters.&#xD;
  &#xD;
        Patient Identification Form: It is a questionnaire that includes sociodemographic&#xD;
        characteristics (gender, age, educational status, income status, employment status and&#xD;
        occupation) and questions about the disease, created by the researchers by scanning the&#xD;
        literature.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The relaxing music group listened to specially composed &quot;MusiCure®&quot; compositions in soft&#xD;
        rhythm, including melodies with harp, cello, strings and sound elements from nature (eg rain,&#xD;
        bird, forest sound).The patients in the experimental group listened to music with headphones&#xD;
        for 20 minutes for three consecutive days.Pain, anxiety and vital parameters were recorded&#xD;
        with data collection tools [Patient Description Form, VAS, FAS, Distress Thermometer,&#xD;
        Edmonton Symptom Scale] before and at the end of the intervention.For the patients in the&#xD;
        aromatherapy group, use 5% lavender oil with a diffuser for 15-20 minutes.&#xD;
  &#xD;
        has been applied.The diffuser was placed 30 cm from the participants and five (5) drops of&#xD;
        essential lavender oil were placed on the filter paper. Within 10-15 minutes after the&#xD;
        completion of the inhalation, data collection forms were applied again and pain, anxiety,&#xD;
        blood pressure, pulse and respiratory rate were evaluated.The patients hospitalized in the&#xD;
        palliative care service were given music with a loudspeaker for three consecutive days with&#xD;
        the effect of aromatherapy inhaler.&#xD;
  &#xD;
        Within 10-15 minutes after the completion of the inhalation, data collection forms were&#xD;
        applied again and pain, anxiety, blood pressure, pulse and respiratory rate were evaluated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 10, 2022</start_date>
    <completion_date type="Actual">July 15, 2023</completion_date>
    <primary_completion_date type="Actual">September 10, 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>Sequential Assignment</intervention_model>
      <intervention_model_description>randomized controlled trial</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analog Scale (VAS)</measure>
      <time_frame>three consecutive days after the start of application</time_frame>
      <description>The Visual Analog Scale (VAS) used for the assessment of pain is used to digitize some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at both ends of a 10 cm or 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Facial Anxiety Scale (FAS)</measure>
      <time_frame>three consecutive days after the start of application</time_frame>
      <description>The Facial Anxiety Scale is a measurement tool in which patients report their anxiety levels. The scale consists of five face shapes with the size of 11 × 42 cm. While the facial expression on the far left indicates the absence of anxiety, the level of anxiety increases towards the right (scored between 0-5). A score of three or more on the Facial Anxiety Scale indicates that the anxiety level is moderate or high.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Distress Thermometer</measure>
      <time_frame>three consecutive days after the start of application</time_frame>
      <description>Distress Thermometer The Thermometer with Distress Thermometer is a likert-type scale with scores from 0 (no stress) to 10 (extreme stress).the class of the values in the degree is indicated as points</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Edmonton Symptom Diagnostic Scale((ESAS)</measure>
      <time_frame>three consecutive days after the start of application</time_frame>
      <description>The patient is asked to match his symptoms with a number that he thinks is most suitable for him from the numbers from 0 to 10. The number 0 indicates no symptoms, the number 10 indicates that the symptom is very severe.All of the items on the ESAS have a value of 0-10 points</description>
    </primary_outcome>
    <primary_outcome>
      <measure>vital parameters</measure>
      <time_frame>three consecutive days after the start of application</time_frame>
      <description>blood pressure measurement, pulse, respiratory rate will be measured.120-129/80-84 mmHg is normal, 130-139/85-89 mmHg( millimeters of mercury (mmHg) ) is called high normal blood pressure.Respirations per minute in a healthy adult person 12-20.(12-20 breaths per minute)It is normal for adults and healthy people to have a heart rate in the range of 60-100 beats per minute.Heart rate (or pulse rate)(heart per minute (beats per minute, or bpm)(60 to 100 bpm);</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">88</enrollment>
    <condition>Cancer</condition>
    <arm_group>
      <arm_group_label>music group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The research is planned as a randomized controlled trial. The individuals in the research group are divided into four groups as music group, aromatherapy group, music and aromatherapy and control group. The relaxing music group will listen to specially composed &quot;MusiCure®&quot; compositions in soft rhythm, including melodies with harp, cello, strings and natural sound elements (eg rain, bird, forest sound). The patients in the experimental group will listen to the music with headphones for 20 minutes for three consecutive days.&#xD;
  Before and at the end of the intervention, data collection tools [Patient Description Form, Vısual analog scale, facial anxiety scale , Distress Thermometer, Edmonton Symptom Scale] will record the characteristics of pain, anxiety and vital parameters.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>aromatherapy group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in the aromatherapy group use 5% lavender oil with a diffuser for 15-20 minutes in accordance with the &quot;Aromatherapy-Clinical Guideline For Midwives. NHS&quot;.&#xD;
  Trust 1-15) has been applied. The diffuser was placed 30 cm from the participants and five (5) drops of essential lavender oil were placed on the filter paper. Within 10-15 minutes after the completion of the inhalation, data collection forms were applied again, and pain, anxiety, blood pressure, pulse and respiratory rate were evaluated.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>aromatherapy and music group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Inpatients in the palliative care service will be given music with headphones for three consecutive days with the effect of aromatherapy inhaler. Within 10-15 minutes after the completion of the inhalation, data collection forms will be applied again and pain, anxiety, blood pressure, pulse and respiratory rate will be evaluated.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants were not interfered with.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>aromatherapy</intervention_name>
      <description>Patients in the aromatherapy group use 5% lavender oil with a diffuser for 15-20 minutes in accordance with the &quot;Aromatherapy-Clinical Guideline For Midwives. NHS&quot;.&#xD;
  Trust 1-15) has been applied. The diffuser was placed 30 cm from the participants and five (5) drops of essential lavender oil were placed on the filter paper. Within 10-15 minutes after the completion of the inhalation, data collection forms were applied again, and pain, anxiety, blood pressure, pulse and respiratory rate were evaluated.</description>
      <arm_group_label>aromatherapy group</arm_group_label>
      <other_name>aromatherapy inhaler.</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>music therapy</intervention_name>
      <description>The relaxing music group listened to specially composed &quot;MusiCure®&quot; compositions in soft rhythm, including melodies with harp, cello, strings and sound elements from nature (eg rain, bird, forest sound). Listened with headphones for 20 minutes.</description>
      <arm_group_label>music group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>aromatherapy and music therapy</intervention_name>
      <description>Inpatients will be given music with a loudspeaker with the effect of aromatherapy inhaler for three consecutive days. Within 10-15 minutes after the completion of the inhalation, data collection forms will be applied again, pain, anxiety, blood pressure, pulse, respiratory rate were evaluated.</description>
      <arm_group_label>aromatherapy and music group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  who volunteered to participate in the research,&#xD;
  &#xD;
            -  18 years and older,&#xD;
  &#xD;
            -  No hearing problem&#xD;
  &#xD;
            -  Doesn't have any problems with smelling healthy,&#xD;
  &#xD;
            -  No communication and speech problems&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  with a diagnosis of psychiatric illness,&#xD;
  &#xD;
            -  Allergic to lavender, perfumes or cosmetics,&#xD;
  &#xD;
            -  Having asthma and chronic obstructive pulmonary disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>DUYGU AKBAŞ UYSAL</last_name>
      <role>Principal Investigator</role>
      <affiliation>PHD.candidate</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>EGE</name>
        <address>
          <city>İzmir</city>
          <state>İ̇zmi̇r</state>
          <zip>3590</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ege University</investigator_affiliation>
      <investigator_full_name>Duygu Akbas Uysal</investigator_full_name>
      <investigator_title>Registered Nurse</investigator_title>
    </responsible_party>
    <keyword>pallative care</keyword>
    <keyword>aromatherapy</keyword>
    <keyword>music therapy</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024954
  org study id: EGE UNIVERSTY
  secondary id: DUYGU AKBAŞ UYSAL
  nct id: NCT06024954
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The research is planned as a randomized controlled trial. The main question[s] it aims to
        answer are:
  
        [question 1]: Does the inhaler effect of music and aromatherapy applied to palliative care
        patients have an effect on pain, anxiety and vital signs?
  
        The individuals in the research group are divided into four groups as music group,
        aromatherapy group, music and aromatherapy and control group. .
  
        Before and at the end of the intervention, data collection tools [Patient Description Form,
        Visual analog scale,face anxiety scale, Distress Thermometer, Edmonton Symptom Scale] will
        record the characteristics of pain, anxiety and vital parameters.
  
        Patient Identification Form: It is a questionnaire that includes sociodemographic
        characteristics (gender, age, educational status, income status, employment status and
        occupation) and questions about the disease, created by the researchers by scanning the
        literature.
  The relaxing music group listened to specially composed "MusiCure®" compositions in soft
        rhythm, including melodies with harp, cello, strings and sound elements from nature (eg rain,
        bird, forest sound).The patients in the experimental group listened to music with headphones
        for 20 minutes for three consecutive days.Pain, anxiety and vital parameters were recorded
        with data collection tools [Patient Description Form, VAS, FAS, Distress Thermometer,
        Edmonton Symptom Scale] before and at the end of the intervention.For the patients in the
        aromatherapy group, use 5% lavender oil with a diffuser for 15-20 minutes.
  
        has been applied.The diffuser was placed 30 cm from the participants and five (5) drops of
        essential lavender oil were placed on the filter paper. Within 10-15 minutes after the
        completion of the inhalation, data collection forms were applied again and pain, anxiety,
        blood pressure, pulse and respiratory rate were evaluated.The patients hospitalized in the
        palliative care service were given music with a loudspeaker for three consecutive days with
        the effect of aromatherapy inhaler.
  
        Within 10-15 minutes after the completion of the inhalation, data collection forms were
        applied again and pain, anxiety, blood pressure, pulse and respiratory rate were evaluated.
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: randomized controlled trial
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Visual Analog Scale (VAS)
  time frame: three consecutive days after the start of application
  description: The Visual Analog Scale (VAS) used for the assessment of pain is used to digitize some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at both ends of a 10 cm or 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing.
  measure: Facial Anxiety Scale (FAS)
  time frame: three consecutive days after the start of application
  description: The Facial Anxiety Scale is a measurement tool in which patients report their anxiety levels. The scale consists of five face shapes with the size of 11 × 42 cm. While the facial expression on the far left indicates the absence of anxiety, the level of anxiety increases towards the right (scored between 0-5). A score of three or more on the Facial Anxiety Scale indicates that the anxiety level is moderate or high.
  measure: Distress Thermometer
  time frame: three consecutive days after the start of application
  description: Distress Thermometer The Thermometer with Distress Thermometer is a likert-type scale with scores from 0 (no stress) to 10 (extreme stress).the class of the values in the degree is indicated as points
  measure: Edmonton Symptom Diagnostic Scale((ESAS)
  time frame: three consecutive days after the start of application
  description: The patient is asked to match his symptoms with a number that he thinks is most suitable for him from the numbers from 0 to 10. The number 0 indicates no symptoms, the number 10 indicates that the symptom is very severe.All of the items on the ESAS have a value of 0-10 points
  measure: vital parameters
  time frame: three consecutive days after the start of application
  description: blood pressure measurement, pulse, respiratory rate will be measured.120-129/80-84 mmHg is normal, 130-139/85-89 mmHg( millimeters of mercury (mmHg) ) is called high normal blood pressure.Respirations per minute in a healthy adult person 12-20.(12-20 breaths per minute)It is normal for adults and healthy people to have a heart rate in the range of 60-100 beats per minute.Heart rate (or pulse rate)(heart per minute (beats per minute, or bpm)(60 to 100 bpm);
  arm group label: music group
  arm group type: Experimental
  description: The research is planned as a randomized controlled trial. The individuals in the research group are divided into four groups as music group, aromatherapy group, music and aromatherapy and control group. The relaxing music group will listen to specially composed "MusiCure®" compositions in soft rhythm, including melodies with harp, cello, strings and natural sound elements (eg rain, bird, forest sound). The patients in the experimental group will listen to the music with headphones for 20 minutes for three consecutive days.
  Before and at the end of the intervention, data collection tools [Patient Description Form, Vısual analog scale, facial anxiety scale , Distress Thermometer, Edmonton Symptom Scale] will record the characteristics of pain, anxiety and vital parameters.
  arm group label: aromatherapy group
  arm group type: Experimental
  description: Patients in the aromatherapy group use 5% lavender oil with a diffuser for 15-20 minutes in accordance with the "Aromatherapy-Clinical Guideline For Midwives. NHS".
  Trust 1-15) has been applied. The diffuser was placed 30 cm from the participants and five (5) drops of essential lavender oil were placed on the filter paper. Within 10-15 minutes after the completion of the inhalation, data collection forms were applied again, and pain, anxiety, blood pressure, pulse and respiratory rate were evaluated.
  arm group label: aromatherapy and music group
  arm group type: Experimental
  description: Inpatients in the palliative care service will be given music with headphones for three consecutive days with the effect of aromatherapy inhaler. Within 10-15 minutes after the completion of the inhalation, data collection forms will be applied again and pain, anxiety, blood pressure, pulse and respiratory rate will be evaluated.
  arm group label: control group
  arm group type: No Intervention
  description: Participants were not interfered with.
  intervention type: Other
  intervention name: aromatherapy
  description: Patients in the aromatherapy group use 5% lavender oil with a diffuser for 15-20 minutes in accordance with the "Aromatherapy-Clinical Guideline For Midwives. NHS".
  Trust 1-15) has been applied. The diffuser was placed 30 cm from the participants and five (5) drops of essential lavender oil were placed on the filter paper. Within 10-15 minutes after the completion of the inhalation, data collection forms were applied again, and pain, anxiety, blood pressure, pulse and respiratory rate were evaluated.
  arm group label: aromatherapy group
  other name: aromatherapy inhaler.
  intervention type: Other
  intervention name: music therapy
  description: The relaxing music group listened to specially composed "MusiCure®" compositions in soft rhythm, including melodies with harp, cello, strings and sound elements from nature (eg rain, bird, forest sound). Listened with headphones for 20 minutes.
  arm group label: music group
  intervention type: Other
  intervention name: aromatherapy and music therapy
  description: Inpatients will be given music with a loudspeaker with the effect of aromatherapy inhaler for three consecutive days. Within 10-15 minutes after the completion of the inhalation, data collection forms will be applied again, pain, anxiety, blood pressure, pulse, respiratory rate were evaluated.
  arm group label: aromatherapy and music group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: DUYGU AKBAŞ UYSAL
  role: Principal Investigator
  affiliation: PHD.candidate
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ege University
  investigator full name: Duygu Akbas Uysal
  investigator title: Registered Nurse
  sharing ipd: No