The Effects of Pre-Transplant Music Therapy for Patients Undergoing Hematopoietic Stem Cell Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in Distress Score
研究概览
简要总结
The purpose of this randomized, controlled study is to determine the effects of pre-transplant music therapy on mood, distress, and physical functioning variables in patients undergoing Hematopoietic Stem Cell Transplant (HSCT).
详细描述
Primary Endpoint:
Compare the difference in distress via Distress Thermometer for patients who receive music therapy and those who do not.
Secondary Endpoints:
Compare the difference in patient perception of pain, anxiety, and mood via Numeric Rating Scale for patients who receive music therapy and those who do not.
Compare the difference in quality of life via Functional Assessment of Cancer Therapy-General (FACT-G7) for patients who receive music therapy and those who do not.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing inpatient allogeneic stem cell transplant
- •Must be fluent in English
- •Must be able to communicate verbally and have no significant hearing impairment
- •Have capacity to provide consent
- •All diagnosis, graft source, donor sources will be included.
排除标准
- •Patients not meeting the above inclusion criteria
研究组 & 干预措施
Music Therapy
Participants in the experimental group will be given choices about how to proceed with the session: active or passive, improvisation, re-creative or receptive songs, or receptive (relaxation). Three music therapy sessions will be completed, the first within 24 hours of admission, the second 24-96 hours of session 1, and the final session the day before stem cell infusion.
干预措施: Music Therapy (Behavioral)
No Music Therapy
Participants randomized to the standard care group will be asked to rate the same symptoms as those in the experimental group. This will mark the beginning of a 45-minute control condition period during which the participants may fill the 45-minute time-period in whatever ways they choose.
干预措施: No Music Therapy (Behavioral)
结局指标
主要结局
Change in Distress Score
时间窗: From admission to day -1 (up to 9 days)
Distress Thermometer assessments for both the experimental and standard care group will be given in the mid-late afternoon. This is an analog scale from 0-10 where 0 indicates no distress and 10 indicates extreme distress.
次要结局
- Change in Pain Score(Up to 24 hours before procedure)
- Change in Mood Score(Up to 24 hours before procedure)
- Change in Quality of Life Score(From admission to day -1 (up to 9 days))
- Total Narcotic Medication Use(From admission to day -1 (up to 9 days))
- Change in Pain Score(Within 24 hours of admission)
- Change in Pain Score(Up to 96 hours after session 1 (120 hours from admission))
- Change in Mood Score(Within 24 hours of admission)
- Change in Mood Score(Up to 96 hours after session 1 (120 hours from admission))