The Effect of Music During Chemotherapy

NCT06180629 | Completed

• 1 other identifier: 2022/03-08
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: Chemotherapy treatment is a very different and difficult process. Considering the many physiological and psychological problems that patients experience during and after the treatment process, chemotherapy symptoms and psychological problems affect the quality of life of patients. Along with the burden of the disease, patients who experience physiological problems during chemotherapy may experience depression, stress, and anxiety. Therefore, this study was conducted to determine the effect of music played during chemotherapy on depression, anxiety, stress levels, and chemotherapy symptoms. Method: This study was conducted in a randomized controlled manner with a pretest-posttest control group random design model. The study population consisted of patients receiving treatment in the outpatient chemotherapy unit of Maltepe University Faculty of Medicine Hospital. The study sample consisted of 49 patients who met the inclusion criteria. The power analysis determined that the sample number was 42 people in total, 21 in the experimental group and 21 in the control group. However, considering the data losses, it was decided that the number would be 25 experimental and 25 control. When one patient from the experimental group did not want to continue, the study was completed with 49 patients, 24 in the experimental group and 25 in the control group. The music recital will be applied 4 times in total, once a week, until the patients complete 1 cycle, i.e. 4 sessions. Patients in the experimental group were administered the Depression, Anxiety, Stress Scale (DASS -42) and Edmonton Symptom Diagnostic Scale (ESDS) before each session until the completion of one cycle, and music was played for 20-25 minutes during chemotherapy. After chemotherapy, the scales were applied again. In the control group, the scales were applied before chemotherapy treatment, no intervention was made during chemotherapy and the scales were applied again after chemotherapy.

Conditions

Depression; Anxiety; Stress; Chemotherapy Effect

Keywords

Depression; Stres; Anxiety; Chemotherapy Effect; Nursing; Music

Outcome Measures

Primary Outcomes (2)

• Depression-Anxiety-Stress Scale (DASS-42)

  The scale consists of a total of 42 items; items with D (14 items) indicate depression, items with A (14 items) indicate anxiety, and items with S (14 items) indicate stress. The scale consists of 14 items, each answered using a 0-3 scale. Where (0) means it has never been applied to me, (3) means it has been applied to me a lot or most of the time. The normal range of scores is 0-9 for depression, 0-7 for anxiety and 0-14 for stress. Scores above these ranges indicate the degree of the problem, from mild to extreme.

  up to 24 weeks

• Edmonton Symptom Diagnostic Scale (ESDS)

  10 symptoms are questioned: pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, feeling unwell, shortness of breath and other problems. The patient is asked to match his/her symptoms with a number from 0 to 10 that he/she thinks best suits him/her. 0 indicates that he/she has no symptoms, 10 indicates that the symptom is very severe.

  up to 24 weeks

Study Arms (2)

Music Consert

EXPERIMENTAL

During the chemotherapy sessions, the patients in the experimental group listened to music for 20-25 minutes, once a week for a total of 4 weeks, by choosing a music genre decided by the patient himself/herself from 3 music genres selected by the researcher based on scientific content and expert opinion.

Behavioral: Music conset

control group

ACTIVE COMPARATOR

The control group continued their normal treatment routine. No application was performed. Only pre-test and post-tests were applied.

Other: normal treatment routine

Interventions

Music conset BEHAVIORAL

The music modes to be used (Rast and Hüseyni), classical music, nature music, and listening time of 20-30 minutes were determined by taking expert opinion from a faculty member from the Conservatory department and by reviewing the literature. The researcher asked the patients to choose the music genres. After each patient decided on the music they wanted to listen to, the researcher recorded the selected music genres on their smartphones. The music playback application was played to the patients in the experimental group for 20-25 minutes in each session for 4 sessions, i.e. 4 times in total, once a week for a month, until the end of one course. During each session, the patients listened to the music genre they had chosen each week.

Music Consert

normal treatment routine OTHER

normal treatment routine

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Can read and write
• Open to communication and cooperation
• Having a smartphone
• No hearing problems
• Not in the terminal period
• No psychiatric treatment
• Receiving chemotherapy 1 time per week
• Patients who have received one course of chemotherapy and come to the first session of the second course
• Being willing and voluntary to participate in the research

Sponsors & Collaborators

• Maltepe University: lead

Study Sites (1)

Maltepe University Hospital

Istanbul, Maltepe, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 22, 2023
• Study Start: June 5, 2023
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)