AzTrials
AzTrials

CancerNCT05262621

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

A study testing progressive muscle relaxation and Listening to relaxing music once/day in people with Cancer, run by The Nethersole School of Nursing at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cancer
What is being tested?
progressive muscle relaxation and Listening to relaxing music once/day
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteVietnam
Study dates
8 Mar 2022to 10 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Vietnam National Cancer Institute, Hanoi Oncology Hospital

    Hanoi, 134000

Other trials in Vietnam

About this study

Official title: 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)

Read the 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.
Conditions
Cancer
Being tested
progressive muscle relaxation, Listening to relaxing music once/day
Keywords
music intervention, progressive muscle relaxation, anxiety, depression, quality of life, chemotherapy, beast cancer, gynaecology cancer
Medical subject headings
Neoplasms, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • progressive muscle relaxationOther

    Practice muscle relaxation for 20 minutes once/a day

  • Listening to relaxing music once/dayOther

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

Study groups in NCT05262621
Study groupRoleWhat they receive
Music intervention combined with progressive muscle relaxationExperimentalMusic intervention combined with progressive muscle relaxation.
Receives: Other: progressive muscle relaxation; Other: Listening to relaxing music once/day
Control groupNo interventionno music therapy will be done.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: ebaseline, T1 after 3 weeks, T2 after 6 weeks

  2. 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.

    Measured: baseline, T1 after 3 weeks, T2 after 6 weeks

Secondary outcomes (4)

  1. 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.

    Measured: baseline, T1 after 3 weeks, T2 after 6 weeks

  2. 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.

    Measured: baseline, T1 after 3 weeks, T2 after 6 weeks

  3. 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.

    Measured: baseline, T1 after 3 weeks, T2 after 6 weeks

  4. 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.

    Measured: baseline, T1 after 3 weeks,

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start8 Mar 2022
  3. Primary completion2 Aug 2022
  4. Study completion10 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05262621
Sponsor's protocol ID
TheNethersole
Status last verified
Apr 2023
First submitted
9 Feb 2022
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40035884

  • 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.

    PubMed 37922279

Questions about this trial

What is this clinical trial studying?

A study testing progressive muscle relaxation and Listening to relaxing music once/day in people with Cancer, run by The Nethersole School of Nursing at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline anxiety at 3 weeks and 6 weeks (time frame: ebaseline, T1 after 3 weeks, T2 after 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05262621, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in