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This Multicenter randomized controlled trial evaluates clinical hypnosis efficacy for reducing perioperative anxiety and postoperative pain in abdominal surgery patients across 3 Moroccan centers (n=48-68). Intervention arm receives 15-20 min level 2 hypnosis session preoperatively; control receives standard psychological preparation. Primary outcome: VAS-anxiety post-intervention. Secondary: postoperative EVA-pain, analgesic consumption, length of stay.
Study Design Prospective, multicenter, parallel-group RCT (1:1 allocation, stratified by center/sex). Inclusion: consenting ASA I-II adults for abdominal surgery. Primary endpoint powered for 10mm EVA reduction (80% power, α=0.05). Registration supports PhD thesis at ISSS/Université Hassan 1er Settat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fisrt arm: patients having a session of hypnosis prior to surgery | Experimental | Patients randomized to the intervention arm undergo a single 15-20 minute clinical hypnosis session preoperatively for anxiety reduction, achieving level 2 hypnotic trance (somnambulism) |
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| Arm 2 : patients will be treated as usual with standard conditions | No Intervention | Patients in this group will receive standard usual care without any hypnotic intervention, only with routine psychological preparation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clincal hypnosis | Other | Patients randomized to the intervention arm receive a single 15-20 minute individual clinical hypnosis session 30-60 minutes preoperatively. The standardized protocol includes:
Delivered by certified hypnotherapist using validated script for preoperative anxiety in abdominal surgery patients." Key Elements Required Timing: Preop holding area, 30-60 min before incision Provider: Trained clinician (specify certification) Dose: Single 15-20 min session Target: Level 2 hypnosis (somnambulism) Outcome link: EVA anxiety scale pre/post This matches your 3-center RCT design (~16 patients/center, stratified randomization) and distinguishes from control arm (standard psychological preparation |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative anxiety | Perioperative Anxiety (Primary Outcome) is measured using the Visual Analog Scale for Anxiety (EVA-Anxiété, 0-100 mm). Primary Outcome Measure: preoperative anxiety level Assessment Tool: 100-mm Visual Analog Scale (VAS-Anxiety): 0 mm = No anxiety ("Je ne suis pas du tout anxieux") 100 mm = Worst possible anxiety ("Anxiété maximale imaginable") Timepoints: (post-intervention, ~10 min later). Expected hypnosis effect: ≥10 mm reduction vs. control. Protocol Specifications Patient marking: Single horizontal 100-mm line; mark position indicates intensity Scoring: Distance (mm) from "No anxiety" (0) to mark, precise to 1 mm | 1 hour Before surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Secondary Outcome Measure: Acute postoperative pain intensity at 6, and 24 hours post-surgery. Assessment Tool: 100-mm VAS-Pain Scale: 0 mm = No pain ("Aucune douleur") 100 mm = Worst imaginable pain ("Douleur maximale imaginable") Timepoints: T+6h, T+24h. Expected hypnosis benefit: ≥10 mm reduction vs. control . Protocol Specifications Patient marking: Horizontal 100-mm line; precise mm measurement from 0 Analgesia standardization: Multimodal protocol identical across arms (paracetamol, NSAIDs, opioids rescue) Power: Secondary analysis leverages primary outcome sample (48-68 patients, 80% power for Δ=10 mm, σ=24 mm) ClinicalTrials.gov Entry: "Postoperative pain intensity measured by 100-mm Visual Analog Scale at rest in PACU at 1, 2, 6, and 24 hours post-surgery" This complements your prim |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YOUSSEF EL-ALLAM EL-ALLAM, Phd student | Contact | +212653977028 | youssef.el-allam.doc@uhp.ac.ma | |
| NAOUFAL HIMMOUCHE Pr Himmouche, Professor | Contact | +212619544601 | naoufal.himmouche@uhp.ac.ma |
| Name | Affiliation | Role |
|---|---|---|
| NAOUFAL HIMMOUCHE HIMMOUCHE, Professor | Laboratory of health sciences and technlmogies, Higher Institute of Health sciences, Hassan Fisrt University, Settat Morocco | Study Director |
| YASSINE HAFIANI, Professor | Pedagogical Unit of Anesthesia and Intensive Care, Rabat Faculty of Medicine and Pharmacy, Mohammed V University, Rabat, Morocco |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenitra, Rabat Sale Kenitra region, Morocco | Completed | Kenitra | Province | 14000 | Morocco | |
Data sharing not planned. Individual patient data will not be shared due to:" Small sample size (n=60 across 3 centers) creates high re-identification risk in Morocco's healthcare context Patient consent forms obtained pre-NIH Policy 2.0 did not include data sharing provisions Doctoral thesis protocol approved by CERB Mohammed V Rabat without data sharing plan Local data protection regulations (Loi 28-13) limit identifiable health data transfer Resource constraints prevent data de-identification and controlled access infrastructure Summary results, statistical analysis plan, and blinded protocol available upon request to corresponding author post-publication.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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This study did not use any kind of masking or blinding,
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| 6 and 24 hours postoperatively |
| medication consumption | Secondary Outcome Measure: Anesthia drugs consumption and postoperative consumption of analgesics (morphine equivalents, paracetamol, NSAIDs, opioids) from PACU arrival to discharge. Assessment Method: Total mg/doses per patient, Data collection: Medication administration records (MAR), nurse logs Expected hypnosis effect: ≥20-30% reduction vs. control arm. Protocol Specifications Standardized multimodal analgesia (identical both arms): | Perioperative |
| length of stay | Secondary Outcome Measure: Time to hospital discharge (days) from surgery day (Day 0) to medical discharge order date. Assessment Method: Calendar days: Date of discharge hour date of surgery Expected hypnosis effect: ≥1 day reduction vs. control (typical LOS 3-5 days abdominal surgery). Protocol Specifications Standardized discharge criteria (identical both arms): Tolerates solid diet VAS-pain ≤30 mm at rest Mobilizes independently to bathroom Afebrile, normal vital signs Data collection: medical record discharge order timestamp | Perioperative |
| Study Director |
| Settat, Casablanca settat region , Morocco |
| Not yet recruiting |
| Settat |
| Province |
| 26000 |
| Morocco |
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| Youssoufia, Marrakech-Safi Morocco | Recruiting | Youssoufia | Province | 46300 | Morocco |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D004191 |
| Behavioral Disciplines and Activities |