REDALEl Impacto del Reiki en el Dolor Postoperatorio y la Calidad de Vida en Pacientes de Cirugía Lumbar
Este estudio tiene como objetivo evaluar el impacto del Reiki en la intensidad del dolor postoperatorio, medido por la Escala Visual Analógica, y en la calidad de vida general de los pacientes que se han sometido a una cirugía lumbar.
Reiki treatment and chirurgy
+ Sham treatment and chirurgy
Enfermedades de los Huesos+7
+ Hernia
+ Enfermedades de las Articulaciones
Estudio de Cuidados de Apoyo
Resumen
Fecha de inicio: 10 de septiembre de 2025
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 60 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Cuidados de Apoyo
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
SimuladoObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 2 ubicaciones
Bizet Clinic
Paris, France