Overview
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).
Description
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
Both groups will receive routine, standard postoperative care, which includes prescribed analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), and standard physical rehabilitation/physiotherapy sessions.
Participants will follow a specific multi-step study process:
Visit 1 (Screening \& Presentation):Meet with the principal investigator to check study eligibility. Patients complete initial SF-12 (quality of life) and VAS (pain) assessments, receive the study information letter/consent form, and are given a 7-day reflection period.
Inclusion \& Randomization:After both the practitioner and patient sign the two copies of the consent form, the patient is randomly assigned in a 1:1 ratio to either Group A (Reiki) or Group B (Sham).
Visit 2 (Pre-Intervention Treatment - 1 Week Before Surgery):Group A: Receives their first Reiki session administered by a certified practitioner with hands positioned above the body in a quiet room.
Group B:Receives their first Sham session administered by a member of the medical staff who simulates the identical hand gestures without delivering energy, maintaining the double-blind setup.
Visit 3 (Intervention):\*\* The scheduled lumbar surgery takes place. Visit 4 (Discharge Visit):The research team provides a recommended postoperative physical rehabilitation program, distributes the daily VAS questionnaire, and evaluates initial analgesic consumption.
Visit 5 (Day 15 Post-Op): Both groups return to the Bizet Clinic for their second designated session (Reiki for Group A; Sham for Group B). Patients complete a scar assessment questionnaire, a VAS pain evaluation, and record their medication intake.
Visit 6 (Day 21 Post-Op):Participants receive a follow-up phone call to record their current VAS pain scores and track analgesic consumption.
Visit 7 (Week 4 Post-Op Follow-Up):Participants undergo a routine radiological exam and a practitioner-led consultation involving a final series of tests: a final VAS pain score, a professional scar assessment, a quality of life questionnaire (SF-12), an analgesic consumption audit, and a patient satisfaction survey using the Clinical Global Impression (CGI) scale.
Note on Safety:Unscheduled visits can be conducted at any stage during the follow-up period if deemed clinically necessary by the surgeon, during which data will be collected directly from the patient's medical record.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
