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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change from baseline anxiety at 3 weeks and 6 weeks
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change from baseline anxiety at 3 weeks and 6 weeks
时间窗: 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
时间窗: 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.
次要结局
- 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,)
研究者
Khanh Thi Nguyen
Principal Investigator
The Nethersole School of Nursing