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

NCT04486443 | Completed DMC

• 1 other identifier: izmirtinaztepeuni
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Nursing Caries; Pain; Music Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: music therapy

control group

NO INTERVENTION

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.

Interventions

music therapy BEHAVIORAL

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.

Also known as: complementary therapy

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• gönül düzgün: lead

Study Sites (1)

Gönül Düzgün

Izmir, Konak, 35590, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Music Therapy; Complementary Therapies

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: IzmrTinaztepeU

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 24, 2020
• Study Start: August 9, 2018
• Primary Completion: August 9, 2019
• Study Completion: February 25, 2020
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (1)