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This study involves patients undergoing lumbar spine surgery (lumbar arthrodesis). It compares the effects of Reiki, an energy-based therapy, with conventional approaches to relieve postoperative pain.
The goal is to determine whether this non-drug method can help reduce pain, limit the use of painkillers, and enhance patient comfort during recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Reiki) | Experimental | treatment with reiki session |
|
| standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Sham) | Placebo Comparator | treatment with sham session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reiki | Other | Reiki sessions for 30 minutes, on Day-7 before the surgery and on D15 after the surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain will be assessed at Day 15 using the VAS ( Visial Analog Scale) | The Visual Analog Scale is a subjective measurement tool commonly used to assess the intensity of pain. It consists of a horizontal 10-centimeter line on which the patient marks a point that reflects their experience. Minimum and maximum values: 0 = complete absence of the symptom 10 = the most severe imaginable intensity of the symptom Score interpretation: Higher scores indicate greater symptom intensity Lower scores indicate lesser intensity | DAY 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life will be assessed using the SF12 | The SF-12 (Short-Form Health Survey) a validated questionnaire designed to assess health-related quality of life across physical and mental domains. It is a shortened version of the SF-36, containing 12 items that cover eight key health dimensions. Scoring:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bouchra BENKESSOU, PM | Contact | 0033140693525 | b.benkessou@hexagone-sante-paris.fr | |
| georges ABI LAHOUD, Professeur | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Bizet | Recruiting | Paris | 75016 | France |
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| ID | Term |
|---|---|
| D019124 | Therapeutic Touch |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| Sham (No Treatment) | Other | Sham sessions for 30 minutes, on D-7 before the surgery and on D15 after the surgery, |
|
| DAY 30 |
| Daily pain intensity will be reported | This daily diary was designed by the research team to record pain intensity using the Visual Analog Scale (VAS), from the day of discharge up to 30 days post-intervention. The Visual Analog Scale is a subjective measurement tool commonly used to assess the intensity of pain. It consists of a horizontal 10-centimeter line on which the patient marks a point that reflects their experience.
Higher scores indicate greater symptom intensity Lower scores indicate lesser intensity | from Day 1 to Day 30 |
| evaluation of patient's overall satisfaction and treatment response | the Clinical Global Impression (CGI) is a clinician-rated scale used to assess the global change in a patient's condition following a medical or therapeutic intervention, compared to their state at baseline. Evaluated on a 7-point scale :
| at Day 30 |
| Assessment of the condition of the scar at the lumbar level | The International Visual Wound Color Scale (IVWCS) This scale is a visual assessment tool that helps clinicians evaluate wound healing by identifying and interpreting the dominant colors present in the wound bed. Each color corresponds to a specific tissue type or healing stage. Color Categories and Their Meanings:
Requires cleaning and possibly debridement May indicate microbial presence or inflammation - Black: Represents necrotic tissue (dead tissue), often due to poor blood supply. Requires urgent medical attention Typically treated with debridement and moist dressings | at Day 15 and Day 30 |
| antalgic consumption will be reported | This daily diary was designed by the research team and records the daily consumption of analgesics from the day of discharge to 30 days post-intervention. Classification of Analgesics in the Daily Diary Analgesic consumption will be categorized according to the standard analgesic step classification:
| from day 1 to day 30 |