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

NCT05262621 | Completed

• 1 other identifier: TheNethersole
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Cancer

Keywords

music intervention; progressive muscle relaxation; anxiety; depression; quality of life; chemotherapy; beast cancer; gynaecology cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change from baseline stress at 3 weeks and 6 weeks

  baseline, T1 after 3 weeks, T2 after 6 weeks

• Change from baseline coping styles at 3 weeks and 6 weeks

  baseline, T1 after 3 weeks, T2 after 6 weeks

• Change from baseline quality of life at 3 weeks and 6 weeks

  baseline, T1 after 3 weeks, T2 after 6 weeks

• Change from baseline satisfaction of nursing care at 3 weeks

  baseline, T1 after 3 weeks,

Study Arms (2)

Music intervention combined with progressive muscle relaxation

EXPERIMENTAL

Music intervention combined with progressive muscle relaxation.

Other: progressive muscle relaxation; Other: Listening to relaxing music once/day

Control group

NO INTERVENTION

no music therapy will be done.

Interventions

progressive muscle relaxation OTHER

Practice muscle relaxation for 20 minutes once/a day

Music intervention combined with progressive muscle relaxation

Listening to relaxing music once/day OTHER

Right after practising progressive muscle relaxation, the participants will listen to relaxing music for 20 minutes

Music intervention combined with progressive muscle relaxation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Nethersole School of Nursing: lead

Study Sites (1)

Vietnam National Cancer Institute, Hanoi Oncology Hospital

Hanoi, 134000, Vietnam

Location

Related Publications (2)

• Nguyen KT, Chan DNS, Cheung AT, Hoang HTX, Truong AT, Chow KM, Choi KC, Chan CWH. Randomised controlled trial of music listening combined with progressive muscle relaxation for mood management in women receiving chemotherapy for cancer. Support Care Cancer. 2025 Mar 4;33(3):245. doi: 10.1007/s00520-025-09281-4.

  PMID: 40035884 DERIVED

• Nguyen KT, Hoang HTX, Bui QV, Chan DNS, Choi KC, Chan CWH. Effects of music intervention combined with progressive muscle relaxation on anxiety, depression, stress and quality of life among women with cancer receiving chemotherapy: A pilot randomized controlled trial. PLoS One. 2023 Nov 3;18(11):e0293060. doi: 10.1371/journal.pone.0293060. eCollection 2023.

  PMID: 37922279 DERIVED

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Khanh Thi Nguyen, master

  The Nethersole School of Nursing, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistants who assess outcome data, data entry and analysis will be blinded to avoid the risk of assessor bias. The assistants will not participate in any other stage of implementing the program.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 2, 2022
• Study Start: March 8, 2022
• Primary Completion: August 2, 2022
• Study Completion: August 10, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)