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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)
Aim: To assess the effect of MCP on anxiety, depression and QoL of BGC patients receiving chemotherapy.
Objectives
Hypothesis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music intervention combined with progressive muscle relaxation | Experimental | Music intervention combined with progressive muscle relaxation. |
|
| Control group | No Intervention | no music therapy will be done. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| progressive muscle relaxation | Other | Practice muscle relaxation for 20 minutes once/a day |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khanh Thi Nguyen, master | The Nethersole School of Nursing, The Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vietnam National Cancer Institute, Hanoi Oncology Hospital | Hanoi | 134000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40035884 | Derived | 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. | |
| 37922279 | Derived |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001326 | Autogenic Training |
| ID | Term |
|---|---|
| D006990 | Hypnosis |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Parallel Assignment
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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.
| Listening to relaxing music once/day | Other | Right after practising progressive muscle relaxation, the participants will listen to relaxing music for 20 minutes |
|
| 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, |
| 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. |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |