Effects of Music Intervention Combined With Progressive Muscle Relaxation in Cancer Patients
- Conditions
- Cancer
- Registration Number
- NCT05262621
- Lead Sponsor
- The Nethersole School of Nursing
- 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)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 84
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline anxiety at 3 weeks and 6 weeks ebaseline, T1 after 3 weeks, T2 after 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.
Change from baseline depression at 3 weeks and 6 weeks baseline, T1 after 3 weeks, T2 after 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.
- Secondary Outcome Measures
Name Time Method Change from baseline quality of life at 3 weeks and 6 weeks baseline, T1 after 3 weeks, T2 after 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.
Change from baseline stress at 3 weeks and 6 weeks baseline, T1 after 3 weeks, T2 after 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.
Change from baseline coping styles at 3 weeks and 6 weeks baseline, T1 after 3 weeks, T2 after 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.Change from baseline satisfaction of nursing care at 3 weeks baseline, T1 after 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.
Trial Locations
- Locations (1)
Vietnam National Cancer Institute, Hanoi Oncology Hospital
🇻🇳Hanoi, Vietnam
Vietnam National Cancer Institute, Hanoi Oncology Hospital🇻🇳Hanoi, Vietnam