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Evaluation of the Effect of Reiki on Pain After Lumbar Surgery (REDAL)

23 de julho de 2026 atualizado por: Clinique Bizet

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).

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comparador Falso: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Pain Intensity
Prazo: 30 days

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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Clinical Global Impression (CGI) Score
Prazo: 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
Daily Pain Score via Daily Diary
Prazo: 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
Wound Healing Phase Evaluation
Prazo: 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
Quality of Life Assessed by SF-12 Questionnaire
Prazo: 30 days

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
Daily Antalgic Medication Consumption
Prazo: 30 days

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

Colaboradores e Investigadores

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Patrocinador

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

10 de setembro de 2025

Conclusão Primária (Estimado)

1 de janeiro de 2028

Conclusão do estudo (Estimado)

1 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

20 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de julho de 2026

Primeira postagem (Real)

23 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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