Evaluation of the Effect of Reiki on Pain After Lumbar Surgery

Официальное название

Evaluation of the Effect of Reiki on Pain After Lumbar Surgery: A Comparative Randomized, Double-blind, Pilot Study

Обзор

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).

Подробное описание

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.

Вмешательства

• Другое Reiki treatment and chirurgy
  Patients 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.
• Другое Sham treatment and chirurgy
  Patients 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.

Первичные конечные точки

• Change in Pain Intensity [Срок оценки: 30 days]

Вторичные конечные точки (5)

• Clinical Global Impression (CGI) Score [Срок оценки: 30 days]
• Daily Pain Score via Daily Diary [Срок оценки: 30 days]
• Wound Healing Phase Evaluation [Срок оценки: 30 days]
• Quality of Life Assessed by SF-12 Questionnaire [Срок оценки: 30 days]
• Daily Antalgic Medication Consumption [Срок оценки: 30 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 2 центра

• Benkessou — Paris
• Bizet Clinic — Paris

Публикации

• Guo X, Long Y, Qin Z, Fan Y. Therapeutic effects of Reiki on interventions for anxiety: a meta-analysis. BMC Palliat Care. 2024 Jun 13;23(1):147. doi: 10.1186/s12904-024-01439-x. PMID 38872168
• Kocoglu F, Zincir H. The Effect of Reiki on Pain, Fatigue, and Quality of Life in Adolescents With Dysmenorrhea. Holist Nurs Pract. 2021 Nov-Dec 01;35(6):306-314. doi: 10.1097/HNP.0000000000000477. PMID 34647912
• Jahantiqh F, Abdollahimohammad A, Firouzkouhi M, Ebrahiminejad V. Effects of Reiki Versus Physiotherapy on Relieving Lower Back Pain and Improving Activities Daily Living of Patients With Intervertebral Disc Hernia. J Evid Based Integr Med. 2018 Jan-Dec;23:2515690X18762745. doi: 10.1177/2515690X18762745. PMID 29536776
• Vitale AT, O'Connor PC. The effect of Reiki on pain and anxiety in women with abdominal hysterectomies: a quasi-experimental pilot study. Holist Nurs Pract. 2006 Nov-Dec;20(6):263-72; quiz 273-4. PMID 17099413
• Thrane S, Cohen SM. Effect of Reiki therapy on pain and anxiety in adults: an in-depth literature review of randomized trials with effect size calculations. Pain Manag Nurs. 2014 Dec;15(4):897-908. doi: 10.1016/j.pmn.2013.07.008. Epub 2014 Feb 28. PMID 24582620
• Jones J. (2018). Use of Reiki for Pain Control in Post-Surgical Patients: A Critical Review of the literature. Thése de Master of Science in the Physician Assistant Program. University of North Carolina.
• Notte BB, Fazzini C, Mooney RA. Reiki's effect on patients with total knee arthroplasty: A pilot study. Nursing. 2016 Feb;46(2):17-23. doi: 10.1097/01.NURSE.0000476246.16717.65. PMID 26760383
• Maqbool M., Javed S., Ahmed A. B. (2019). Assessment of Pain management in PostOperative Cases Using Different Scales and Questionnaires. Indo American Journal of Pharmaceutical Sciences, 6(1): 983-987. doi:

Идентификаторы

NCT: NCT07722117 · 2024-A02685-42-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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