Reiki-Brachy: An Interventional Treatment Trial Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Comparison between the treatment groups of the change in anxiety from Assessment 1 to Assessment 3 as measured by the 6-item Spielberger State Anxiety Scale.
研究概览
简要总结
The goal of this open label, randomized, controlled clinical trial is to assess the benefits of providing Reiki therapy to subjects receiving their first brachytherapy treatment for gynecological malignancies.
Participants will either receive a session of Reiki therapy or usual care during the standard wait time between the placement of the brachytherapy device and brachytherapy treatment. Questionnaires will be administered at various time points on the day of the participant's first brachytherapy treatment as well as at the three month follow-up time point.
Researchers will compare the intervention (Reiki therapy) and control (usual care) groups to assess the impact of the Reiki therapy on anxiety, pain, state anxiety, depression, and physiological measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject aged ≥ 18 years.
- •Pathologically confirmed malignancy of the endometrium, cervix, vagina or vulva.
- •Eligible to undergo brachytherapy treatment as an outpatient procedure.
- •Able to read and understand English and/or Spanish.
- •Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- •Willing to participate in either the Reiki therapy or standard of care arm regardless of treatment assignment.
排除标准
- •Prior brachytherapy treatment for a gynecological malignancy.
- •Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
研究组 & 干预措施
Reiki Therapy
Participants randomized to Arm 1 will receive a session of Reiki therapy during the standard wait time between the placement of the brachytherapy device and their first brachytherapy treatment.
干预措施: Reiki therapy (Other)
Standard of Care
Participants randomized to the standard of care control arm will be asked to remain in a clinic room during the standard waiting period between the placement of the brachytherapy device and the start of brachytherapy treatment. Participants may participate in any activity other than Reiki therapy during this time. Participants may be accompanied by a family member or friend.
结局指标
主要结局
Comparison between the treatment groups of the change in anxiety from Assessment 1 to Assessment 3 as measured by the 6-item Spielberger State Anxiety Scale.
时间窗: 4 months
To assess the impact of Reiki therapy on anxiety in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm. The 6-item Spielberger State Anxiety Scale is a validated shortened version of the Spielberger State-Trait Anxiety Inventory (STAI) used to measure state anxiety. The scale utilizes a Likert scale with four response categories assigned numerical values from 1-4 ("not at all,""somewhat,""moderately," and "very much").
次要结局
- Comparison between the treatment groups of the change in anxiety from Assessment 1 to Assessment 3 as measured by the Visual Analog Scale - Pain.(4 months)
- Comparison between the treatment groups of the change in state anxiety and depression from Assessment 1 to three month post-radiation as measured by the Hospital Anxiety and Depression Scale.(4 months)
- Comparison between the treatment groups of the change in pain from Assessment 1 to Assessment 3 as measured by the Visual Analog Scale - Pain.(4 months)
- Comparison between the treatment groups of the change in anxiety from Assessment 2 to Assessment 3 as measured by the 6-item Spielberger State Anxiety Scale.(4 months)