<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/NCT04486443</url>
  </required_header>
  <id_info>
    <org_study_id>izmirtinaztepeuni</org_study_id>
    <nct_id>NCT04486443</nct_id>
  </id_info>
  <brief_title>Effect of Music on Pain in Cancer Patients in Palliative Care Service: a Randomized Controlled Study</brief_title>
  <acronym>nursingcare</acronym>
  <official_title>Effect of Music on Pain in Cancer Patients in Palliative Care Service: a Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>gönül düzgün</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Izmir Tinaztepe University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Background: Palliative care services can be applied in chronic, life-threatening conditions&#xD;
      such as cancer, and provide physical, mental and psychological support to patients worldwide.&#xD;
      Purpose: This study aimed to investigate the effect of music on pain, anxiety, comfort and&#xD;
      functional capacity of cancer patients received care in a palliative care unit.&#xD;
&#xD;
      Methods: The population of this randomized controlled trial consisted of cancer patients&#xD;
      hospitalized in the Palliative Care Service of a Training and Research Hospital between July&#xD;
      2018-July 2019. The sample of the study included 60 patients (30 interventions/30 controls)&#xD;
      who met the inclusion criteria. The patients in the intervention group were given a total of&#xD;
      six music sessions, ten minutes each with the Turkish classical music in maqams (modes) of&#xD;
      their choice (Hejaz or Rast accompanied by an expert tambour (drum) player).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The incidence of chronic diseases and conditions including cancer that require a long-term&#xD;
      treatment process and also affect the individual psychological status and quality of life has&#xD;
      increased with a high financial burden as a result of relatively prolonged human life under&#xD;
      the influence of contemporary medicine. Palliative care services can be applied in chronic,&#xD;
      life-threatening conditions such as cancer, and provide physical, mental and psychological&#xD;
      support to patients worldwide. Symptoms including pain, constipation, diarrhea, anorexia,&#xD;
      dysphagia, nausea and vomiting, dehydration, depression, delirium, and fatigue may&#xD;
      demonstrate in cancer patients receiving palliative care, while most of the them have&#xD;
      complain of pain. Studies have reported that 30% of cancer patients experienced pain at the&#xD;
      diagnosis, 50-70% of them in during treatment period, and 60-80% of them in the terminal&#xD;
      period. It was determined in another study that 90% of patients had pain when they were&#xD;
      hospitalized in palliative care service, and more than half of them defined the pain severity&#xD;
      at 5 and above.&#xD;
&#xD;
      Pharmacological agents were used to manage pain control, as they had rapid effect and were&#xD;
      easily applicable. In addition to pharmacological agents, the application of&#xD;
      non-pharmacological interventions is important for improving the quality of life and patient&#xD;
      comfort and reducing the symptom burden in relieving pain caused by the side effects and&#xD;
      methods of treatment in the palliative care cancer patients. Since non-pharmacological&#xD;
      methods could reduce pain by applying alone or in combination with drugs, the frequency of&#xD;
      use has increased in recent years. Music therapy was used as a non-pharmacological method in&#xD;
      many health problems as a traditional treatment and psychosocial interventions. The study was&#xD;
      aimed to investigate the effects of music therapy on pain in patients with cancer&#xD;
      hospitalized palliative care service. In the current study we tested the hypothesis that&#xD;
      palliative care patients' pain management. 1. reduce the rate of pain score. 2. reduce the&#xD;
      rate of anxiety scoe. 3. To increase the rate of comfort level. 4. To increase the rate of&#xD;
      functional capacity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 9, 2018</start_date>
  <completion_date type="Actual">February 25, 2020</completion_date>
  <primary_completion_date type="Actual">August 9, 2019</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>
    <intervention_model_description>Participants individually randomised to one of two &quot;parallel&quot; groups (Özdemir O 2009). It was considered sufficient to select the participants in the intervention and control groups with the similar 3-4 variables including age and gender (Büyüköztürk Ş 2016). Therefore, patients in the intervention and control groups were randomized according to age, gender and disease stage. The coin tossing method was used to determine which group the patients would involve in. All patients continued to use all medications prescribed before, during and after the research, and no interventions and changes were performed to the patients in this regard. Pain scores of all patients were at 3 and above and they received narcotic analgesics. Researcher generated the allocation sequence, enrolled participants, and assigned participants to interventions.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>primary Outcome Measure</measure>
    <time_frame>3 weeks</time_frame>
    <description>Patient Information Form involved questions including patients' socio-demographic data.&#xD;
Patient Follow-Up Form was for recording of vital signs and pain levels before and after the application.&#xD;
K-MASF consisted of three parts: the nature of the pain, its severity, and general pain intensity.&#xD;
GCS consisted of three levels and four dimensions. STAI was a self-assessment questionnaire consisting of short expressions. The questionnaire required patients to describe how they feel under certain conditions and to answer the scale with their feelings about these conditions.&#xD;
KPC was prognostic indicator for the patient's normal activities and functional capacity.&#xD;
There was a significant difference between the mean total pain scores, anxiety, comfort and functional capacityof the patients in the intervention and control groups before and after music therapy.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Nursing Caries</condition>
  <condition>Pain</condition>
  <condition>Music Therapy</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the intervention group received music therapy in 10-minutes sessions with the support of a specialist using the Turkish classical music (Hejaz and Rast modes) accompanied by a tambour. All forms were applied to the group before the music therapy, respectively. Prior to musical therapy, the patient's preferred classical music (Rast or Hejaz modes) was asked by the specialist and 10 minutes of music therapy was performed according to patient's choice. Clinical data and pain scores were obtained 5, 30 and 60 minutes after music therapy. 6 sessions of music therapy were applied on different days. Patient Follow-up Form was recorded before and after each therapy. The forms were evaluated 3 times, before the application, after the 3rd and 6th application.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group consisted of patients who only received analgesic treatment and underwent routine nursing care, and didn't have any interventions. All forms were assessed 3 times, before application, after the 3rd application and after the 6th application. The Patient Information Form and K-MASF were applied only once.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>music therapy</intervention_name>
    <description>patients in the intervention group received music therapy in 10-minutes sessions with the support of a specialist from the Conservatory Department in the Ege University, using the Turkish classical music (Hejaz and Rast modes) accompanied by a tambour.</description>
    <arm_group_label>Intervention Group</arm_group_label>
    <other_name>complementary therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who were older than 18 years old, speaking and understanding Turkish&#xD;
             language, volunteering to participate in the study, diagnosed with cancer and&#xD;
             hospitalized in a palliative care service, defined &quot;moderate&quot; or &quot;severe&quot; pain (&gt;3&#xD;
             Visual Analog Scale scores) despite using opioid or analgesic, not in the terminal&#xD;
             period, and not in bedridden status were included the study. Also, patients without&#xD;
             cognitive impairment or brain metastases, and without clinical diagnosis or findings&#xD;
             of dementia, hearing problems, agitation or delirium were enrolled the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who were younger than 18 years old, not know speaking and understanding&#xD;
             Turkish language, not to be volunteering to participate in the study, not diagnosed&#xD;
             with cancer and not hospitalized in a palliative care service, Visual Analog Scale&#xD;
             scores lower than 3 point, in the terminal period, and in bedridden status and&#xD;
             patients with cognitive impairment or brain metastases, and with clinical diagnosis or&#xD;
             findings of dementia, hearing problems, agitation or delirium weren't included the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gönül Düzgün</name>
      <address>
        <city>İzmir</city>
        <state>Konak</state>
        <zip>35590</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Izmir Tinaztepe University</investigator_affiliation>
    <investigator_full_name>gönül düzgün</investigator_full_name>
    <investigator_title>IzmrTinaztepeU</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
  </patient_data>
  <!-- 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/NCT04486443
org study id: izmirtinaztepeuni
nct id: NCT04486443
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: Palliative care services can be applied in chronic, life-threatening conditions
      such as cancer, and provide physical, mental and psychological support to patients worldwide.
      Purpose: This study aimed to investigate the effect of music on pain, anxiety, comfort and
      functional capacity of cancer patients received care in a palliative care unit.

      Methods: The population of this randomized controlled trial consisted of cancer patients
      hospitalized in the Palliative Care Service of a Training and Research Hospital between July
      2018-July 2019. The sample of the study included 60 patients (30 interventions/30 controls)
      who met the inclusion criteria. The patients in the intervention group were given a total of
      six music sessions, ten minutes each with the Turkish classical music in maqams (modes) of
      their choice (Hejaz or Rast accompanied by an expert tambour (drum) player).
The incidence of chronic diseases and conditions including cancer that require a long-term
      treatment process and also affect the individual psychological status and quality of life has
      increased with a high financial burden as a result of relatively prolonged human life under
      the influence of contemporary medicine. Palliative care services can be applied in chronic,
      life-threatening conditions such as cancer, and provide physical, mental and psychological
      support to patients worldwide. Symptoms including pain, constipation, diarrhea, anorexia,
      dysphagia, nausea and vomiting, dehydration, depression, delirium, and fatigue may
      demonstrate in cancer patients receiving palliative care, while most of the them have
      complain of pain. Studies have reported that 30% of cancer patients experienced pain at the
      diagnosis, 50-70% of them in during treatment period, and 60-80% of them in the terminal
      period. It was determined in another study that 90% of patients had pain when they were
      hospitalized in palliative care service, and more than half of them defined the pain severity
      at 5 and above.

      Pharmacological agents were used to manage pain control, as they had rapid effect and were
      easily applicable. In addition to pharmacological agents, the application of
      non-pharmacological interventions is important for improving the quality of life and patient
      comfort and reducing the symptom burden in relieving pain caused by the side effects and
      methods of treatment in the palliative care cancer patients. Since non-pharmacological
      methods could reduce pain by applying alone or in combination with drugs, the frequency of
      use has increased in recent years. Music therapy was used as a non-pharmacological method in
      many health problems as a traditional treatment and psychosocial interventions. The study was
      aimed to investigate the effects of music therapy on pain in patients with cancer
      hospitalized palliative care service. In the current study we tested the hypothesis that
      palliative care patients' pain management. 1. reduce the rate of pain score. 2. reduce the
      rate of anxiety scoe. 3. To increase the rate of comfort level. 4. To increase the rate of
      functional capacity.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants individually randomised to one of two "parallel" groups (Özdemir O 2009). It was considered sufficient to select the participants in the intervention and control groups with the similar 3-4 variables including age and gender (Büyüköztürk Ş 2016). Therefore, patients in the intervention and control groups were randomized according to age, gender and disease stage. The coin tossing method was used to determine which group the patients would involve in. All patients continued to use all medications prescribed before, during and after the research, and no interventions and changes were performed to the patients in this regard. Pain scores of all patients were at 3 and above and they received narcotic analgesics. Researcher generated the allocation sequence, enrolled participants, and assigned participants to interventions.
primary purpose: Supportive Care
masking: Single (Participant)
measure: primary Outcome Measure
time frame: 3 weeks
description: Patient Information Form involved questions including patients' socio-demographic data.
Patient Follow-Up Form was for recording of vital signs and pain levels before and after the application.
K-MASF consisted of three parts: the nature of the pain, its severity, and general pain intensity.
GCS consisted of three levels and four dimensions. STAI was a self-assessment questionnaire consisting of short expressions. The questionnaire required patients to describe how they feel under certain conditions and to answer the scale with their feelings about these conditions.
KPC was prognostic indicator for the patient's normal activities and functional capacity.
There was a significant difference between the mean total pain scores, anxiety, comfort and functional capacityof the patients in the intervention and control groups before and after music therapy.
arm group label: Intervention Group
arm group type: Experimental
description: Patients in the intervention group received music therapy in 10-minutes sessions with the support of a specialist using the Turkish classical music (Hejaz and Rast modes) accompanied by a tambour. All forms were applied to the group before the music therapy, respectively. Prior to musical therapy, the patient's preferred classical music (Rast or Hejaz modes) was asked by the specialist and 10 minutes of music therapy was performed according to patient's choice. Clinical data and pain scores were obtained 5, 30 and 60 minutes after music therapy. 6 sessions of music therapy were applied on different days. Patient Follow-up Form was recorded before and after each therapy. The forms were evaluated 3 times, before the application, after the 3rd and 6th application.
arm group label: control group
arm group type: No Intervention
description: The control group consisted of patients who only received analgesic treatment and underwent routine nursing care, and didn't have any interventions. All forms were assessed 3 times, before application, after the 3rd application and after the 6th application. The Patient Information Form and K-MASF were applied only once.
intervention type: Behavioral
intervention name: music therapy
description: patients in the intervention group received music therapy in 10-minutes sessions with the support of a specialist from the Conservatory Department in the Ege University, using the Turkish classical music (Hejaz and Rast modes) accompanied by a tambour.
arm group label: Intervention Group
other name: complementary therapy
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Izmir Tinaztepe University
investigator full name: gönül düzgün
investigator title: IzmrTinaztepeU
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code