Evaluation of the Effectiveness of Hypnosis Support on Patient Perception of Outpatient Surgery U… (NCT03926403) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Effectiveness of Hypnosis Support on Patient Perception of Outpatient Surgery Under Local Anaesthesia
France66 participantsStarted 2020-01-28
Plain-language summary
Many clinical trials assessing the effectiveness of hypnosis have been conducted in recent years, some of which show that hypnosis reduces pain perception better than drug treatments administered to control groups, and that it is at least as effective as other complementary therapies (such as massage, acupuncture, yoga). However, their conclusions are limited by a significant risk of bias, and further studies with rigorous methodology remain necessary. The hypothesis of this study is that hypnosis support methods can reduce anxiety in patients requiring facial surgery under local anaesthesia, and thus improve their medical management.
The purpose of this study is to evaluate the effectiveness of hypnosis support on the patient's state of anxiety before and after outpatient surgery under local anaesthesia in the Maxillofacial Surgery Department.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
variation in Spielberger's anxiety self-assessment questionnaire score between the patient's arrival in the operating room and his departure
Timeframe: on the day of surgery under local anaesthesia.