Effects of Music Intervention Combined With Progressive Muscle Relaxation in Cancer Patients

Effects of Music Intervention Combined With Progressive Muscle Relaxation on Anxiety, Depression and Quality of Life in Breast and Gynaecological Cancer Patients Receiving Chemotherapy: A Randomized Controlled Trial

Study design A 2-arm, assessor-blinded randomised controlled trial will be conducted. The design will follow the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT)

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: progressive muscle relaxation; Other: Listening to relaxing music once/day

Detailed Description

Aim: To assess the effect of MCP on anxiety, depression and QoL of BGC patients receiving chemotherapy.

Objectives

• To assess the effect of MCP on the anxiety of BGC patients receiving chemotherapy.
• To assess the effect of MCP on depression of BGC patients receiving chemotherapy.
• To assess the effect of MCP on QoL and patients' satisfaction of BGC patients receiving chemotherapy.
• To determine whether stress level, coping and coping styles mediate the intervention effect on anxiety, depression and QoL.

Hypothesis

• The participants receiving MCP will have a significantly lower level of anxiety compared to the control group.
• The participants receiving MCP will have a significantly lower level of depression compared to the control group.
• The participants receiving MCP will have significantly higher QoL scores and levels of satisfaction with care service compared to the control group.
• Stress level, coping will mediate the intervention on target outcomes.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khanh Thi Nguyen, master; Phone Number: +852 55731892; Email: khanhnguyen@link.cuhk.edu.hk
• Study Contact Backup: Name: Khanh Thi Nguyen, master; Phone Number: +84 972052806; Email: khanhnguyenndun@gmail.com

Study Locations

• Vietnam
  • Hanoi, Vietnam, 134000
    • Vietnam National Cancer Institute, Hanoi Oncology Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women with breast or gynaecological cancer are 18 years of age or older, and are independent legally to sign the consent form.
• Living with family and having an adult family member agree to participate in the meeting part of the program.
• Had been informed the cancer diagnosis
• Have Karnofsky score (Mor et al., 1984) ≥ 80 ( to be able to self-practice MCP)
• Can communicate, read and write in Vietnamese
• Have a device such as a smartphone, MP3 to keep the audio file (to self-practice MCP at home)
• Consent to join the study

Exclusion Criteria:

• The patients cannot understand the study procedures
• Have mental health illness, deafness, blindness
• Have not been aware of their cancer or the purpose of chemotherapy
• Be participating in other studies related to psychological issues
• Be receiving anxiety or depression treatment.
• Be participating in relaxation therapy such as yoga, meditation, mindfulness, PMR...
• Have a potential treatment (eg. surgery) or personal plans that will prevent them from practising daily during the 6 weeks of the intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music intervention combined with progressive muscle relaxation; Music intervention combined with progressive muscle relaxation.	Other: progressive muscle relaxation; Practice muscle relaxation for 20 minutes once/a day; Other: Listening to relaxing music once/day; Right after practising progressive muscle relaxation, the participants will listen to relaxing music for 20 minutes
No Intervention: Control group; no music therapy will be done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline anxiety at 3 weeks and 6 weeks	it will be measured using the short form of the Depression Anxiety Stress Scale (DASS-21). It includes 7 items for anxiety (DASS21-A). A 4-point Likert-type scale ranging from 0 to 3 was designed for each item, and the scores will need to be multiplied by 2 to calculate the final score. Thus, the anxiety score can range from 0 to 42. The higher the score is the more severe anxiety. The score of 0-7 is normal, 8-9 mild, 10-14 moderate, 15-19 severe, +20 extremely severe.	ebaseline, T1 after 3 weeks, T2 after 6 weeks
Change from baseline depression at 3 weeks and 6 weeks	it will be measured using the short form of the Depression Anxiety Stress Scale (DASS-21). It includes 7 items for depression (DASS21-D). A 4-point Likert-type scale ranging from 0 to 3 was designed on each item, and the scores will need to be multiplied by 2 to calculate the final score. Thus, the depression score can range from 0 to 42. The higher the score is the more severe depression. The score of 0-9 is normal, 10-13 mild, 14-20 moderate, 21-27 severe, +28 extremely severe.	baseline, T1 after 3 weeks, T2 after 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline stress at 3 weeks and 6 weeks	it will be measured using the short form of the Depression Anxiety Stress Scale (DASS-21). It includes 7 items for stress (DASS21-S). A 4-point Likert-type scale ranging from 0 to 3 was designed for each item, and the scores will need to be multiplied by 2 to calculate the final score. Thus, the stress score can range from 0 to 42. The higher the score is the more severe stress. The score of 0-14 is normal, 15-18 mild, 19-25 moderate, 26-33 severe, +34 extremely severe.	baseline, T1 after 3 weeks, T2 after 6 weeks
Change from baseline coping styles at 3 weeks and 6 weeks	Coping will be measured using Brief COPE. The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event.The scale can determine someone's primary coping styles with scores on the following three subscale: Problem-Focussed Coping, Emotion-Focussed Coping, Avoidant Coping.A 4-point Likert-type scale ranging from 1 to 4 was designed on each item.	baseline, T1 after 3 weeks, T2 after 6 weeks
Change from baseline quality of life at 3 weeks and 6 weeks	coping will be measured using FACT-G.It evaluates in functional scales on Social/family well-being (SWB); Emotional well-being (EWB) and Functional well-being (FWB). Each item is scored in one of five categories of 0-4, with 'Not at all', 'A little bit', 'some what', 'Quite a bit' 'Very much'. The higher the score is the better quality of life." The possible range of scores is from 0 to 112.	baseline, T1 after 3 weeks, T2 after 6 weeks
Change from baseline satisfaction of nursing care at 3 weeks	satisfaction of nursing care will be measured using numerical rating scale.(0-10) from 0 = completely dissatisfied with the care to 10 = completely satisfied with the care.	baseline, T1 after 3 weeks,

Collaborators and Investigators

• Sponsor: The Nethersole School of Nursing
• Investigators: Principal Investigator: Khanh Thi Nguyen, master, The Nethersole School of Nursing, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2022
• Primary Completion (Actual): August 2, 2022
• Study Completion (Actual): August 10, 2022

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 20, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: chemotherapy; quality of life; depression; anxiety; music intervention; progressive muscle relaxation; beast cancer; gynaecology cancer
• Other Study ID Numbers: TheNethersole

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No