Evaluation of the Effect of Reiki on Pain After Lumbar Surgery: A Comparative Randomized, Double-blind, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- pain intensity
研究概览
简要总结
The goal of this clinical trial (prospective, comparative, and randomized double-blind study) is to learn if Reiki (a non-pharmacological intervention), when used alongside standard care, can treat and reduce postoperative pain in patients recovering from lumbar surgery (60 participants total, divided into two groups of 30).
The main questions it aims to answer are:
Does Reiki significantly reduce postoperative pain levels at day 15 (measured by a Visual Analog Scale) compared to a Sham (placebo) treatment? Does Reiki improve patient quality of life, enhance scar healing, lower daily analgesic consumption, and increase overall patient satisfaction compared to the Sham treatment?
Researchers will compare Group A (30 patients receiving Reiki sessions alongside usual care) to Group B (30 patients receiving Sham/placebo sessions alongside usual care) to see if the Reiki group experiences lower pain levels, reduced need for painkillers, better healing, and higher overall satisfaction and quality of life.
Participants will:
- Receive standard postoperative care following their lumbar surgery.
- Be randomly assigned to receive either two sessions of actual Reiki therapy or two sessions of a Sham (placebo) treatment.
- Evaluate their daily pain levels using a Visual Analog Scale (EVA).
- Complete follow-up assessments at specific intervals (Day 15, Day 21, and Day 30) to track pain levels, pain medication intake, scar healing (using a colorimetric scale), quality of life (via the SF-12 questionnaire), and overall satisfaction (via the Clinical Global Impression scale).
详细描述
The goal of this clinical trial (prospective, comparative, and randomized double-blind study) is to learn if Reiki (a non-pharmacological intervention), when used alongside standard care, can treat and reduce postoperative pain in patients recovering from lumbar surgery (60 participants total, divided into two groups of 30).
The main questions it aims to answer are:
- Does Reiki significantly reduce postoperative pain levels at day 15 (measured by a Visual Analog Scale) compared to a Sham (placebo) treatment?
- Does Reiki improve patient quality of life, enhance scar healing, lower daily analgesic consumption, and increase overall patient satisfaction compared to the Sham treatment?
Researchers will compare Group A (30 patients receiving two Reiki sessions alongside standard care) to Group B (30 patients receiving two Sham/placebo sessions alongside standard care) to see if the Reiki group experiences lower pain levels, reduced need for painkillers, better healing, and higher overall satisfaction and quality of life.
Participant Timeline and Interventions
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject aged 18 years or older.
- •Referred for a lumbar surgery.
- •Absence of participation in another clinical study.
- •Subject affiliated with a social security scheme or beneficiary of such a scheme.
排除标准
- •Neuropathic patient
- •Presence of neuropathic pain
- •Diagnosis of fibromyalgia
- •Received therapeutic touch, polarity therapy, or professional massage therapy in the past four weeks
- •Unable to undergo medical follow-up for the study
- •Adult subject protected by law, under guardianship or trusteeship
研究组 & 干预措施
Group A treated with Reiki
Standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Reiki).
干预措施: Reiki treatment and chirurgy (Other)
Groupe B control treated with Sham
standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Sham)
干预措施: Sham treatment and chirurgy (Other)
结局指标
主要结局
pain intensity
时间窗: 30 days
Visual Analog Scale (VAS) as a pivotal tool for quantifying subjective experiences, particularly focusing on pain intensity. Patients were asked to indicate their level of pain by marking a point on a straight line, ranging from "no pain" to "worst pain imaginable (0-10)." This method provided a numerical score, measured in millimeters, reflecting the intensity of pain perceived by the patient
Change in Pain Intensity
时间窗: 30 days
Change in self-reported pain intensity measured using the Visual Analog Scale (VAS). The scale consists of 0 (no pain) to 10 (worst pain imaginable), where higher scores indicate a worse outcome. Unit of Measure: Scale range (0 to 10)
次要结局
- Clinical Global Impression(30 days)
- Daily pain intensity and antalgic consumption diary(30 days)
- The International Visual Wound Color Scale(30 days)
- The SF12 questionnaire(30 days)
- Clinical Global Impression (CGI) Score(30 days)
- Daily Pain Score via Daily Diary(30 days)
- Wound Healing Phase Evaluation(30 days)
- Quality of Life Assessed by SF-12 Questionnaire(30 days)
- Daily Antalgic Medication Consumption(30 days)