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REDALReiki's Impact on Postoperative Pain and Quality of Life in Lumbar Surgery Patients

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Study Aim

This study aims to evaluate the impact of Reiki on postoperative pain intensity, as measured by the Visual Analog Scale, and overall quality of life in patients who have undergone lumbar surgery.

What is being tested

Reiki treatment and chirurgy

+ Sham treatment and chirurgy

Other
Who is being recruted

Bone Diseases+8

+ Hernia

+ Joint Diseases

Over 18 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-Controlled
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorClinique Bizet
Study ContactBouchra BENKESSOU Chef de projet Recherche CliniqueMore contacts
Last updated: July 23, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 10, 2025

Actual date on which the first participant was enrolled.

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.

Principal SponsorClinique Bizet
Study ContactBouchra BENKESSOU Chef de projet Recherche CliniqueMore contacts
Last updated: July 23, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesHerniaJoint DiseasesMusculoskeletal DiseasesSpinal CurvaturesSpinal DiseasesPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalAnkylosisIntervertebral Disc DisplacementScoliosis

Criteria

1 inclusion criteria required to participate
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

1 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Reiki).

Group II

Sham
standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Sham)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Benkessou

Paris, FranceOpen Benkessou in Google Maps
Recruiting

Bizet Clinic

Paris, France
Recruiting
2 Study Centers