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CompletedNCT07370974HypnoanxietyUpdated Sep 11, 2026

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

An interventional study of Clincal hypnosis in Hypnosis, Preoperative Anxiety and Postoperative Pain, sponsored by HASSAN 1st university. Completed at 3 sites in Morocco. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by HASSAN 1st university · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

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

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Keywords

  • RCT
  • Morocco
  • Hypnosis
  • preoperative anxiety
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's enrollment of 48 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

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Lead sponsor

HASSAN 1st university is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Consenting patients undergoing abdominal surgery

    1. physical status
    2. Able to understand and respond to instructions
    3. No major psychological disorders

Exclusion criteria

  1. Non-consenting patients

    1. Prior experience with hypnosis
    2. History of mental illness
    3. Psychoactive substance consumption
    4. Cognitive disorders
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • OtherClincal 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

    Also known as: Hypnosis, hypnotism, Hypnosis session

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What researchers measure

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 surgery

Secondary 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 postoperatively

  2. 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: Perioperative

  3. 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: Perioperative

07

Study locations

3 sites
  • Kenitra, Rabat Sale Kenitra region, Morocco
    Kenitra, Province 14000, Morocco
  • Settat, Casablanca settat region , Morocco
    Settat, Province 26000, Morocco
  • Youssoufia, Marrakech-Safi Morocco
    Youssoufia, Province 46300, Morocco
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References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07370974
Lead sponsor
HASSAN 1st university
Responsible party
YOUSSEF EL-ALLAM (Principal investigator, HASSAN 1st university) — Principal investigator
First posted
Jan 27, 2026
Start date
Feb 7, 2026
Primary completion
Mar 20, 2026
Completion
Jun 3, 2026
Last update
Sep 11, 2026

Study contacts

NAOUFAL HIMMOUCHE HIMMOUCHE, Professor
study director · Laboratory of health sciences and technlmogies, Higher Institute of Health sciences, Hassan Fisrt University, Settat Morocco
YASSINE HAFIANI, Professor
study director · Pedagogical Unit of Anesthesia and Intensive Care, Rabat Faculty of Medicine and Pharmacy, Mohammed V University, Rabat, Morocco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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