- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07722117
Evaluation of the Effect of Reiki on Pain After Lumbar Surgery (REDAL)
Evaluation of the Effect of Reiki on Pain After Lumbar Surgery: A Comparative Randomized, Double-blind, Pilot Study
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).
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Bouchra BENKESSOU Chef de projet Recherche Clinique
- Telefonnummer: +33 7 64 48 60 16
- E-Mail: b.benkessou@hexagone-sante-paris.fr
Studienorte
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Paris, Frankreich, 75016
- Rekrutierung
- Bizet Clinic
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Kontakt:
- benkessou BOUCHRA
- Telefonnummer: 0764486016
- E-Mail: b.benkessou@cliniques-bltparis.fr
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Paris, Frankreich, 75016
- Rekrutierung
- Benkessou
-
Kontakt:
- benkessou BOUCHRA
- Telefonnummer: 0764486016
- E-Mail: b.benkessou@hexagone-sante-paris.fr
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Group A treated with Reiki
Standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Reiki).
|
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.
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Schein-Komparator: Groupe B control treated with Sham
standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Sham)
|
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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Pain Intensity
Zeitfenster: 30 days
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Change in self-reported pain intensity measured using the Visual Analog Scale (VAS). The scale consists of 0 (no pain) to 10 (worst pain imaginable), where higher scores indicate a worse outcome. Unit of Measure: Scale range (0 to 10) |
30 days
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Clinical Global Impression (CGI) Score
Zeitfenster: 30 days
|
Evaluation of the patient's overall condition assessed by clinicians using the Clinical Global Impression (CGI) scale. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients), where higher scores indicate a worse outcome. Unit of Measure: Score on a scale (0 to 7) |
30 days
|
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Daily Pain Score via Daily Diary
Zeitfenster: 30 days
|
Daily pain severity reported by the patient in a daily diary using a Visual Analog Scale (VAS) from discharge to 30 days post-intervention. The score ranges from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicate a worse outcome. Unit of Measure: Score on a scale (0 to 10) |
30 days
|
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Wound Healing Phase Evaluation
Zeitfenster: 30 days
|
Assessment of wound healing progression using the International Visual Wound Color Scale. The scale categorizes the predominant tissue type into discrete stages: Necrosis, Infection, Fibrin, Granulation, and Epithelializing tissue, where progression toward Epithelializing tissue indicates a better outcome. Unit of Measure: Categorical / Nominal stage |
30 days
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Quality of Life Assessed by SF-12 Questionnaire
Zeitfenster: 30 days
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Impact of health on everyday life measured using the 12-Item Short Form Health Survey (SF-12). Scores range from 0 to 100, where higher scores indicate a better outcome (better health-related quality of life). (Note: Standard SF-12 uses converted domain scores ranging from 0 to 100 ;but in this study sub-items containing score range from 0 to 5 is used instead). And overall results it score up to 100. |
30 days
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Daily Antalgic Medication Consumption
Zeitfenster: 30 days
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Daily consumption of pain medication recorded by the patient in a daily diary from discharge to 30 days post-intervention. Unit of Measure: Milligrams per day (mg/day) (or Pills per day, depending on how you record it) |
30 days
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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:
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2024-A02685-42-1
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