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

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Other: progressive muscle relaxation
* Other: Listening to relaxing music once/day


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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, | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music intervention, progressive muscle relaxation, anxiety, depression, quality of life, chemotherapy, beast cancer, gynaecology cancer