The Effects of Music Therapy on Improving Psychological States of Cancer Patients Undergoing MRI Scans and a Relevant Mediator
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Symptom distress
研究概览
简要总结
The primary objective of this study is to examine the effects of a music therapy protocol on improving anxiety, symptom distress, and relaxation among cancer patients who are going through MRI scanning. Physiological data, such as pulse rates and respiration rates will be collected. Furthermore, data about scanning efficiency will be collected to assess if scanning efficiency is affected by the protocol implementation. The secondary study objective is to assess whether or not there is a relationship between patient attention to music during the intervention process and the changes in anxiety, symptom distress, and relaxation.
详细描述
To assess the protocol, recruited participants will be randomly allocated into two groups: a control group or a music therapy group. Participants in the control group will receive standard care as usual, and they will be offered music therapy interventions upon their request during subsequent appointments. Participants in the music group will receive standard care and music therapy interventions. All participants will rate their psychological states pre- and post-MRI exams. Their physiological data will be recorded during the examination. After the scanning, they will complete an experience review.
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
- Double (Participant, Care Provider)
盲法说明
All participants will be wearing a headphone, and they will not know if there will be music until they experience and finish the scan process.
Radiographers are blinding to avoid biases.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is diagnosed with cancer;
- •The subject is between 18- 60 years old;
- •The subject understands Mandarin, Cantonese, or English;
- •The subject did not use medication for sedatives, anxiolytics, and/or sleep aids;
- •The subject is awake without cognitive disorders;
- •the subject rates more than 0 on the 0-10 VAS for anxiety;
- •The subject has finished primary school level education.
排除标准
- •The subject withdraws the MRI scan;
- •The subject needs other intervention(s) to complete the scan;
- •The subject has hearing and/or visual impairments;
- •The subject has a history of a severe somatic psychiatric disease or clinically diagnosed mental disorders.
研究组 & 干预措施
Music Therapy Group
Participants in the Music Therapy Group will receive standard care and approximately 15 minutes of music therapy before the MRI scan and will have music played through their headphones during the scanning process.
干预措施: Music therapy (Other)
Control Group
Participants in the Control Group will receive standard care throughout the awaiting period and the scanning process.
结局指标
主要结局
Symptom distress
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 days
Self-rating scale (VAS 0-10) to rate symptom distress, with 0 being no distress and 10 being extreme distressed.
Relaxation
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 days
Self-rating scale (VAS 0-10) to rate relaxation, with 0 being unrelaxed and 10 being very relaxed.
Anxiety
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 days
Self-rating scale (VAS 0-10) to rate patient anxiety, with 0 being no anxiety and 10 being extreme anxious
次要结局
- Pulse rates(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 day)
- Respiration rate(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- Scanning efficiency(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- Patient satisfaction level(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 days)
- Patient attention to music (only for the music therapy group)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 days)