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

NCT07370974 | Recruiting DMC

• 1 other identifier: Hypnosis UHP
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Hypnosis; Preoperative Anxiety; Postoperative Pain; Abdominal Surgeries; Length of Stay

Keywords

RCT; Morocco; Hypnosis; preoperative anxiety

Outcome Measures

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

  1 hour Before surgery

Secondary Outcomes (3)

• Postoperative pain

  6 and 24 hours postoperatively

• medication consumption

  Perioperative

• length of stay

  Perioperative

Study Arms (2)

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)

Other: Clincal hypnosis

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.

Interventions

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: * 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

Also known as: Hypnosis, hypnotism, Hypnosis session

Fisrt arm: patients having a session of hypnosis prior to surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting patients undergoing abdominal surgery
• ASA I-II physical status
• Able to understand and respond to instructions
• No major psychological disorders

You may not qualify if:

• Non-consenting patients
• Prior experience with hypnosis
• History of mental illness
• Psychoactive substance consumption
• Cognitive disorders

Sponsors & Collaborators

• HASSAN 1st university: lead

Study Sites (3)

Kenitra, Rabat Sale Kenitra region, Morocco

Kenitra, Province, 14000, Morocco

COMPLETED

Settat, Casablanca settat region , Morocco

Settat, Province, 26000, Morocco

NOT YET RECRUITING

Youssoufia, Marrakech-Safi Morocco

Youssoufia, Province, 46300, Morocco

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• 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 DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study did not use any kind of masking or blinding,
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 27, 2026
• Study Start: December 22, 2025
• Primary Completion: March 20, 2026
• Study Completion: April 20, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

MO (3)