REDALL'impact du Reiki sur la douleur postopératoire et la qualité de vie chez les patients ayant subi une chirurgie lombaire
Cette étude vise à évaluer l'impact du Reiki sur l'intensité de la douleur postopératoire, mesurée par l'Échelle visuelle analogique, et sur la qualité de vie générale des patients ayant subi une intervention chirurgicale lombaire.
Reiki treatment and chirurgy
+ Sham treatment and chirurgy
Maladies osseuses+8
+ Hernie
+ Maladies des Articulations
Soins de support
Résumé
Date de début de l'étude : 10 septembre 2025
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.60 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Soins de support
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
50% de chances d'être dans le groupe placebo en aveugle
Groupes de traitement
Groupe I
ExpérimentalGroupe II
Dispositif fictifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 2 sites
Bizet Clinic
Paris, France