Hypnosis support to reduce anxiety for adults undergoing outpatient facial surgery with local anaesthesia.
Evaluation of the Effectiveness of Hypnosis Support on Patient Perception of Outpatient Surgery Under Local Anaesthesia in the Maxillo-Facial Surgery Department of the CHU Amiens-Picardie.
This will try hypnosis to see if it lowers anxiety in adults having outpatient facial surgery under local anaesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT03926403 on ClinicalTrials.gov |
What this trial studies
The protocol enrolls adults scheduled for outpatient (ultra-short circuit) facial surgery under local anaesthesia who score ≥36 on the Spielberger State-Trait Anxiety Inventory (STAI). After informed consent and baseline STAI, participants receive hypnosis support techniques in the perioperative period and their anxiety scores are collected again on the same day. The trial uses pre- and post-procedure STAI measures to determine whether hypnosis reduces perioperative anxiety and improves medical management without adding pharmacologic side effects. Patients with cognitive disorders, hearing impairment, minors, those under general anaesthesia, or treated in conventional inpatient care are excluded.
Who should consider this trial
Good fit: Adults (≥18) scheduled for outpatient facial surgery under local anaesthesia at the CHU Amiens Maxillofacial Surgery Department who can give informed consent and have a baseline STAI score ≥36.
Not a fit: Patients under general anaesthesia, minors, those with cognitive impairment or hearing loss, or those treated in inpatient or standard ambulatory circuits are not eligible and would not benefit from this protocol.
Why it matters
Potential benefit: If successful, hypnosis support could lower perioperative anxiety, improve patient experience, and reduce reliance on anxiolytic medications for outpatient facial surgery.
How similar studies have performed: Previous trials have suggested hypnosis can reduce pain and anxiety compared with some drug or complementary approaches, but many studies carried risk of bias so stronger evidence is still needed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient treated under local anaesthesia in the Maxillo Facial Surgery department with ultra-short circuit * Patient undergoing face surgery * Patient who has received appropriate information and has provided informed consent * Adult patient ≥ 18 years old * Patient with a score of ≥ 36 on the initial anxiety self-assessment questionnaire Exclusion Criteria: * Patient under general anaesthesia * Patients treated in conventional inpatient care or in the traditional ambulatory circuit * Patient under guardianship or trusteeship * Minor patient \< 18 years of age * Patient who has not provided informed consent or who cannot submit to the study protocol * Patient suffering from cognitive disorders (ex: Alzheimer's disease) * Patients who are deaf or hearing-impaired
Where this trial is running
Amiens
- CHU Amiens Picardie — Amiens, France (Recruiting)
Study contacts
- Principal investigator: Bernard Devauchelle, Pr — CHU Amiens
- Study coordinator: Martine Gosset, ORN
- Email: gosset.martine@chu-amiens.fr
- Phone: (33)322089050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.