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).
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.
Neuropathic patient
Presence of neuropathic pain
Diagnosis of fibromyalgia
Received therapeutic touch, polarity therapy, or professional massage therapy in the past four weeks
Parallel
Reiki treatment and chirurgy
Other interventionPatients will receive a Reiki session one week before the intervention. The scheduled intervention will take place.In addition to the study treatments, a recommended postoperative physical rehabilitation program will be suggested to the patients and then they will have their second Reiki session at the Bizet Clinic and complete the scar questionnaire, VAS, and analgesic consumption.
Sham treatment and chirurgy
Other interventionPatients will receive a Sham session one week before the intervention. The scheduled intervention will take place.In addition to the study treatments, a recommended postoperative physical rehabilitation program will be suggested to the patients and then they will have their second Reiki session at the Bizet Clinic and complete the scar questionnaire, VAS, and analgesic consumption.
Change in Pain Intensity
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)
Clinical Global Impression (CGI) Score
Evaluation of the patient's overall condition assessed by clinicians using the Clinical Global Impression (CGI) scale. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients), where higher scores indicate a worse outcome. Unit of Measure: Score on a scale (0 to 7)
Daily Pain Score via Daily Diary
Daily pain severity reported by the patient in a daily diary using a Visual Analog Scale (VAS) from discharge to 30 days post-intervention. The score ranges from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicate a worse outcome. Unit of Measure: Score on a scale (0 to 10)
Wound Healing Phase Evaluation
Assessment of wound healing progression using the International Visual Wound Color Scale. The scale categorizes the predominant tissue type into discrete stages: Necrosis, Infection, Fibrin, Granulation, and Epithelializing tissue, where progression toward Epithelializing tissue indicates a better outcome. Unit of Measure: Categorical / Nominal stage
Quality of Life Assessed by SF-12 Questionnaire
Impact of health on everyday life measured using the 12-Item Short Form Health Survey (SF-12). Scores range from 0 to 100, where higher scores indicate a better outcome (better health-related quality of life). (Note: Standard SF-12 uses converted domain scores ranging from 0 to 100 ;but in this study sub-items containing score range from 0 to 5 is used instead). And overall results it score up to 100.
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