Effects of Reiki Therapy on Biopsychological Outcomes in Women With Fibromyalgia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change From Baseline in Fibromyalgia Impact After 4 Week
研究概览
简要总结
The goal of this randomized clinical trial is to evaluate the effects of a 4-week Reiki therapy program in women with fibromyalgia. The main questions it aims to answer are:
Does Reiki therapy lead to a greater change in pain intensity compared with a placebo intervention after 4 weeks of treatment?
Does Reiki therapy lead to a greater change in the impact of fibromyalgia compared with a placebo intervention after 4 weeks of treatment?
Researchers will also evaluate whether Reiki therapy affects depressive symptoms, anxiety symptoms, sleep quality, and acute changes in pain intensity, heart rate, and respiratory rate.
Researchers will compare participants receiving Reiki therapy with participants receiving a placebo intervention to determine whether changes in these outcomes differ between groups.
Participants will:
be randomly assigned to either the Reiki therapy group or the placebo group; receive one 30-minute intervention session per week for 4 weeks; complete assessments of pain intensity, fibromyalgia impact, depressive symptoms, anxiety symptoms, and sleep quality before and after the 4-week intervention period; have pain intensity, heart rate, and respiratory rate assessed immediately before and after each intervention session to evaluate acute responses.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Female participants aged 18 years or older.
- •Medical diagnosis of fibromyalgia, confirmed according to the 2016 American College of Rheumatology (ACR) criteria using the Brazilian version of the Fibromyalgia Survey Questionnaire (FSQ-Brazil).
排除标准
- •Clinically unstable medical condition.
- •Presence of acute injuries.
- •Pregnancy.
- •Cognitive impairment or any other condition that prevents the participant from completing the study questionnaires.
研究组 & 干预措施
Sham Reiki Group
Participants assigned to this arm will be positioned under the same conditions as participants in the Reiki Intervention Group and will remain in the intervention setting for 30 minutes; however, no hand imposition or Reiki intervention will be administered. Sessions will occur once weekly for 4 weeks
干预措施: Sham Reiki Intervention (Other)
Reiki Therapy Group
Participants assigned to this arm will receive a 30-minute Reiki intervention through hand imposition, once weekly for 4 weeks.
干预措施: Reiki Intervention (Other)
结局指标
主要结局
Change From Baseline in Fibromyalgia Impact After 4 Week
时间窗: Baseline and 4 weeks
The impact of fibromyalgia will be assessed using the Revised Fibromyalgia Impact Questionnaire (FIQR). The total score ranges from 0 to 100, with higher scores indicating greater impact of fibromyalgia on health and daily functioning. Change from baseline to the end of the 4-week intervention period will be evaluated.
Change From Baseline in Pain Intensity After 4 Weeks
时间窗: Baseline and 4 weeks
Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their current pain intensity on a scale ranging from 0 to 10, with higher scores indicating greater pain intensity. Change from baseline to the end of the 4-week intervention period will be evaluated.
次要结局
- Change From Baseline in Depressive Symptoms After 4 Weeks(Baseline and 4 weeks)
- Change From Baseline in Anxiety Symptoms After 4 Weeks(Baseline and 4 weeks)
- Change From Baseline in Sleep Quality After 4 Weeks(Baseline and 4 weeks)
- Acute Change in Pain Intensity Following Intervention Sessions(Immediately before and immediately after each of the four weekly intervention sessions)
- Acute Change in Heart Rate Following Intervention Sessions(Immediately before and immediately after each of the four weekly intervention sessions)
- Acute Change in Respiratory Rate Following Intervention Sessions(Immediately before and immediately after each of the four weekly intervention sessions)