Effect of Clinical Hypnosis in Preoperative Anxiety Among Patients Undergoing an Abdominal Surgery.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHASSAN 1st university
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Consenting patients undergoing abdominal surgery
ASA I-II physical status
Able to understand and respond to instructions
No major psychological disorders
Disqualifiers
Non-consenting patients
Prior experience with hypnosis
History of mental illness
Psychoactive substance consumption
Trial design
Design model
Parallel
Treatments tested in this trial
Clincal hypnosis
Other interventionPatients randomized to the intervention arm receive a single 15-20 minute individual clinical hypnosis session 30-60 minutes preoperatively. The standardized protocol includes: * Induction phase (3-5 min): Eye fixation, progressive relaxation breathing * Deepening phase (5 min): Level 2 somnambulistic trance achievement * Therapeutic suggestions (7-10 min): Anxiety reduction imagery, surgical calm visualization * Emergence phase (2-3 min): Safe awakening to alert consciousness 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
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Fisrt arm: patients having a session of hypnosis prior to surgeryExperimental treatment 1 intervention
Group B: Arm 2 : patients will be treated as usual with standard conditionsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
1 hour Before surgerySecondary outcomes
1
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
Time frame
6 and 24 hours postoperatively2
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):
Time frame
Perioperative3
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
Time frame
PerioperativeSponsors and contacts
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Source ClinicalTrials.gov