Effect of Music on Pain in Cancer Patients in Palliative Care Service: a Randomized Controlled Study

Pain Clinical Trial

— nursingcare  

Official title:

Effect of Music on Pain in Cancer Patients in Palliative Care Service: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486443
• Other study ID #: izmirtinaztepeuni
• Status: Completed
• Phase: N/A
• Start date: August 9, 2018
• Est. completion date: February 25, 2020

Study information

• Verified date: July 2020
• Source: Izmir Tinaztepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 25, 2020
• Est. primary completion date: August 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who were older than 18 years old, speaking and understanding Turkish language, volunteering to participate in the study, diagnosed with cancer and hospitalized in a palliative care service, defined "moderate" or "severe" pain (>3 Visual Analog Scale scores) despite using opioid or analgesic, not in the terminal period, and not in bedridden status were included the study. Also, patients without cognitive impairment or brain metastases, and without clinical diagnosis or findings of dementia, hearing problems, agitation or delirium were enrolled the study.

Exclusion Criteria:

• Patients who were younger than 18 years old, not know speaking and understanding Turkish language, not to be volunteering to participate in the study, not diagnosed with cancer and not hospitalized in a palliative care service, Visual Analog Scale scores lower than 3 point, in the terminal period, and in bedridden status and patients with cognitive impairment or brain metastases, and with clinical diagnosis or findings of dementia, hearing problems, agitation or delirium weren't included the study.

Related Conditions & MeSH terms

• Music Therapy
• Nursing Caries
• Pain

Intervention

Behavioral:
• music therapy
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.

Locations

Country	Name	City	State
Turkey	Gönül Düzgün	Izmir	Konak

Sponsors (1)

Lead Sponsor	Collaborator
gönül düzgün

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary Outcome Measure	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.	3 weeks