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NCT Number: NCT07370974

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kenitra, Rabat Sale Kenitra region, Morocco, Kenitra, Province, Morocco

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • Consenting patients undergoing abdominal surgery
  • ASA I-II physical status
  • Able to understand and respond to instructions
  • No major psychological disorders
  • Exclusion Criteria:
  • Non-consenting patients
  • Prior experience with hypnosis
  • History of mental illness
  • Psychoactive substance consumption
  • Cognitive disorders

Treatment and study plan

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

Other names: Hypnosis, hypnotism, Hypnosis session

Primary outcomes

  1. Preoperative anxiety

    Time frame: 1 hour Before surgery

    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

Secondary outcomes

  1. Postoperative pain

    Time frame: 6 and 24 hours postoperatively

    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

  2. medication consumption

    Time frame: Perioperative

    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):

  3. length of stay

    Time frame: Perioperative

    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

Study contacts

Contact information is provided by the study sponsor or research team.

NAOUFAL HIMMOUCHE Pr Himmouche, Professor

CONTACT

[email protected]

+212619544601

YOUSSEF EL-ALLAM EL-ALLAM, Phd student

CONTACT

[email protected]

+212653977028

Sponsors and collaborators

Lead sponsor

HASSAN 1st university

Other

Registry information

Official study title

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

Acronym: Hypnoanxiety

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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