Effect of Clinical Hypnosis in Preoperative Anxiety Among Patients Undergoing an Abdominal Surgery. (Hypnoanxiety)

Effect of Clinical Hypnosis in Preoperative Anxiety Among Patients Undergoing an Abdominal Surgery : a Multicenter Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Preoperative Anxiety; Hypnosis; Length of Stay; Abdominal Surgeries
• Intervention / Treatment: Other: Clincal hypnosis

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YOUSSEF EL-ALLAM EL-ALLAM, Phd student; Phone Number: +212653977028; Email: youssef.el-allam.doc@uhp.ac.ma
• Study Contact Backup: Name: NAOUFAL HIMMOUCHE Pr Himmouche, Professor; Phone Number: +212619544601; Email: naoufal.himmouche@uhp.ac.ma

Study Locations

• Morocco
  • Province
    • Kenitra, Province, Morocco, 14000
      • Completed
      • Kenitra, Rabat Sale Kenitra region, Morocco
    • Settat, Province, Morocco, 26000
      • Not yet recruiting
      • Settat, Casablanca settat region , Morocco
      • Contact: YOUSSEF Mr EL-ALLAM, PhD student; Phone Number: +212653997028; Email: youssef.el-allam.doc@gmail.com
      • Contact: Noufal Himmouche Pr HIMMOUCHE, Professor; Phone Number: +21219544601; Email: naoufal.himmouche@uhp.ac.ma
      • Principal Investigator: YOUSSEF EL-ALLAM EL-ALLAM, Phd student
      • Sub-Investigator: AYOUB LILOU Mr LILOU, Masters degree
    • Youssoufia, Province, Morocco, 46300
      • Recruiting
      • Youssoufia, Marrakech-Safi Morocco
      • Contact: YOUSSEF Mr EL-ALLAM, PhD student; Phone Number: +212653997028; Email: youssef.el-allam.doc@gmail.com
      • Principal Investigator: YOUSSEF EL-ALLAM EL-ALLAM, Phd student
      • Contact: ABDELAAZIZ BOUSBEGH Mr BOUSBEGH, Head Nurse Anesthetist; Phone Number: +212630175700; Email: abdelaazizbousbegh@gmail.com
      • Sub-Investigator: Aasmae Benhssayne Mme BENHSSAYNE, anesthestist nurse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• Inclusion Criteria:

  1. Consenting patients undergoing abdominal surgery
  2. ASA I-II physical status
  3. Able to understand and respond to instructions
  4. No major psychological disorders

• Exclusion Criteria:

  1. Non-consenting patients
  2. Prior experience with hypnosis
  3. History of mental illness
  4. Psychoactive substance consumption
  5. Cognitive disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fisrt arm: patients having a session of hypnosis prior to surgery; 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)	Other: Clincal hypnosis; Patients 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; Other Names: Hypnosis, hypnotism; Hypnosis session
No Intervention: Arm 2 : patients will be treated as usual with standard conditions; Patients in this group will receive standard usual care without any hypnotic intervention, only with routine psychological preparation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: HASSAN 1st university
• Investigators: Study Director: 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

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2026
• Primary Completion (Actual): March 20, 2026
• Study Completion (Estimated): June 3, 2026

Study Registration Dates

• First Submitted: January 2, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Hypnosis; RCT; preoperative anxiety; Morocco
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Therapeutics; Mind-Body Therapies; Complementary Therapies; Psychotherapy; Behavioral Disciplines and Activities; Hypnosis
• Other Study ID Numbers: Hypnosis UHP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No