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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- The Nethersole School of Nursing
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Change from baseline anxiety at 3 weeks and 6 weeks
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Khanh Thi Nguyen
Principal Investigator
The Nethersole School of Nursing
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change from baseline anxiety at 3 weeks and 6 weeks
Time Frame: 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
Time Frame: 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 Outcomes
- Change from baseline quality of life at 3 weeks and 6 weeks(baseline, T1 after 3 weeks, T2 after 6 weeks)
- 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 satisfaction of nursing care at 3 weeks(baseline, T1 after 3 weeks,)