HypnosisHypnoanxietyNCT07370974
Effect of Clinical Hypnosis in Preoperative Anxiety Among Patients Undergoing an Abdominal Surgery.
A study testing Clincal hypnosis in people with Hypnosis and Preoperative Anxiety, run by HASSAN 1st university at 3 sites in Morocco.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypnosis, Preoperative Anxiety, Postoperative Pain
- What is being tested?
- Clincal hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesMorocco
- Study dates
- 7 Feb 2026to 3 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting patients undergoing abdominal surgery
- ASA I-II physical status
- Able to understand and respond to instructions
- No major psychological disorders
Who cannot join
- Non-consenting patients
- Prior experience with hypnosis
- History of mental illness
- Psychoactive substance consumption
- Cognitive disorders
Trial locations and contacts
3 sites in 1 country.
Morocco3 sites
Kenitra, Rabat Sale Kenitra region, Morocco
Kenitra, Province, 14000
Settat, Casablanca settat region , Morocco
Settat, Province, 26000
Youssoufia, Marrakech-Safi Morocco
Youssoufia, Province, 46300
About this study
Official title: 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.
- Being tested
- Clincal hypnosis
- Keywords
- RCT, Morocco, Hypnosis, preoperative anxiety
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clincal hypnosisOther
Also called Hypnosis, hypnotism, Hypnosis session
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour Before surgery
Secondary outcomes (3)
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
Measured: 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):
Measured: 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
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start7 Feb 2026
- Primary completion20 Mar 2026
- Study completion3 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- HASSAN 1st university
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YOUSSEF EL-ALLAM, HASSAN 1st university
- Investigators
- NAOUFAL HIMMOUCHE HIMMOUCHE, Professor, Study director, Laboratory of health sciences and technlmogies, Higher Institute of Health sciences, Hassan Fisrt University, Settat MoroccoYASSINE HAFIANI, Professor, Study director, Pedagogical Unit of Anesthesia and Intensive Care, Rabat Faculty of Medicine and Pharmacy, Mohammed V University, Rabat, Morocco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370974
- Sponsor's protocol ID
- Hypnosis UHP
- Acronym
- Hypnoanxiety
- Status last verified
- Sep 2026
- First submitted
- 2 Jan 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Clinical Hypnosis in Preoperative Anxiety Among Patients Undergoing an Abdominal Surgery : a Multicenter Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07370974
- Acronym / sponsor ID
- Hypnoanxiety / Hypnosis UHP
- Keywords
- RCT, Morocco, Hypnosis, preoperative anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- HASSAN 1st universityUniversity, hospital or other
- Study start
- 7 Feb 2026 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fisrt arm: patients having a session of hypnosis prior to surgery | Experimental | Other: Clincal hypnosisPatients randomized to the intervention arm undergo a single 15-20 minute clinical hypnosis session preoperatively for anxiety reduction, achieving level 2 hypnotic trance (somnambulism) |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clincal hypnosisAlso: Hypnosis, hypnotism, Hypnosis sessionPatients 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 | Fisrt arm: patients having a session of hypnosis prior to surgery |
Primary outcome
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
3 secondary outcomes
Postoperative pain
Time frame: 6 and 24 hours postoperatively
medication consumption
Time frame: Perioperative
length of stay
Time frame: Perioperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clincal hypnosis in people with Hypnosis and Preoperative Anxiety, run by HASSAN 1st university at 3 sites in Morocco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative anxiety (time frame: 1 hour Before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.