Reiki Therapy to Improve Key Symptoms in Integrative Oncology Clinic (REIKI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Recruitment rate as measured by the percentage of participants enrolled
研究概览
简要总结
The purpose of this research is to investigate the delivery of Reiki to integrative oncology patients and assess its potential for improving cancer-related symptoms in this population.
详细描述
Reiki is a biofield therapy originating in Japan, in which a trained practitioner places their hands on or above the body of a receiver or themselves to generate a relaxation and healing response. Systematic reviews and meta-analyses report Reiki to be effective for improving psychological and physical health symptoms. With respect to adults with cancer, Reiki has been shown to improve participants' relaxation, pain, fatigue, sleep, anxiety, stress, and wellbeing/quality of life compared to care as usual. However, one study showed no improvement in comfort and wellbeing in those receiving Reiki compared to sham Reiki control, but those receiving Reiki reported improvements above usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neoplasm diagnosis (i.e., ICD-10 C00 - D49) confirmed in electronic health record (EHR)/Caisis
- •Receiving care at a UH Connor Whole Health Integrative Oncology Clinic.
- •Reporting at least three ESAS symptoms ≥4/10 at baseline screening including fatigue and ≥2 other symptoms on the 9-item questionnaire.
- •Able to speak and understand English.
- •Has an email address, and access to a computer with internet and/or a mobile device with a functioning data plan
排除标准
- •Significant cognitive impairment that has not been corrected.
- •Significant visual impairment that has not been corrected.
- •Unable to provide informed consent.
- •Active psychosis.
- •Pregnancy.
- •Metastatic disease.
- •Reiki therapy within 3 months of study enrollment
- •Active immunotherapy, chemotherapy, or radiation treatment, or completed within 3 months before study start. Aromatase inhibitors and tamoxifen are exceptions.
结局指标
主要结局
Recruitment rate as measured by the percentage of participants enrolled
时间窗: 8 weeks post enrollment
Calculated by total number of participants enrolled/ total number of participants eligible and 90% is considered successful for the recruitment rate.
Retention rate as measured by the number of participants retained until the final survey point
时间窗: 8 weeks post enrollment
Calculated by number of participants retained until the final survey time point / number of participants enrolled. 70% of participant retention until the final survey time point will be considered successful.
Attendance rate as measured by number of sessions attended per 6 sessions
时间窗: 8 weeks post enrollment
Total number of sessions attended per 6 sessions. Attendance rate of \>/= 70% will be considered successful
Data completeness rate
时间窗: 8 weeks post enrollment
Data completeness of \>/= 90% is considered satisfactory
Protocol adherence rate as measured by the number of participants treated in manner consistent with the intervention
时间窗: 8 weeks post enrollment
Number of participants treated in manner consistent with intervention/total number of participants enrolled
Acceptability as measured by the patient mean of participant satisfaction survey
时间窗: 8 weeks post enrollment
As assessed by participants mean for the Participants' satisfaction survey with the Reiki sessions, measured on a scale from 0 (Not at all satisfied) to 10 (Completely satisfied)
次要结局
- Patient-reported outcomes as measured by PROMIS-29(Patient-Reported Outcomes Measurement Information System) score(Baseline, 8 weeks)
- Patient-reported outcomes as measured by ESAS(Edmonton Symptom Assessment System) scale(Upto 8 weeks)