Evaluation of the Effectiveness of Hypnosis Support on Patient Perception of Outpatient Surgery Under Local Anaesthesia (HYPNOFACE)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Hypnosis; Outpatient Surgery; Local Anaesthesia; FACE
• Intervention / Treatment: Other: State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire"); Procedure: hypnosis techniques; Procedure: local anaesthesia

Detailed Description

Interventions performed under local anaesthesia may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. In order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines. Hypnosis in particular has long been used in the non-pharmacological management of pain and anxiety.

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.

Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will be informed of the study in consultation by the maxillofacial surgeon. If they give their informed consent, a State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire") will be given to them and collected on the same day. Each patient's anxiety score will be calculated so as to select only patients who are at least lightly anxious about their management (score ≥ 36). The latter will be randomized into 2 groups, one benefiting from experimental management based on hypnosis techniques and the other benefiting from conventional management.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martine Gosset, ORN; Phone Number: (33)322089050; Email: gosset.martine@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80000
    • Recruiting
    • CHU Amiens Picardie
    • Contact: Stéphanie DAKPE, MD; Email: dakpe.stéphanie@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnosis; Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on hypnosis techniques.	Other: State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire"); Patients will be given, a State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire") that will be collected on the same day. Each patient's initial anxiety score will be calculated so as to select only patients who are at least lightly anxious about their management (score ≥ 36).; Procedure: hypnosis techniques; Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on hypnosis techniques.
Active Comparator: conventional management; Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from conventional management (local anaesthesia).	Other: State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire"); Patients will be given, a State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire") that will be collected on the same day. Each patient's initial anxiety score will be calculated so as to select only patients who are at least lightly anxious about their management (score ≥ 36).; Procedure: local anaesthesia; Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from conventional management (local anaesthesia).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
variation in Spielberger's anxiety self-assessment questionnaire score between the patient's arrival in the operating room and his departure	The State-Trait Anxiety Inventory (STAI) (or Spielbergers's anxiety self-assessment questionnaire) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety.	on the day of surgery under local anaesthesia.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value reported by the patient on the Visual Analogue Pain Scale after surgery	The visual analogue scale (VAS) is commonly used as the outcome measure. It is usually presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."	on the day of surgery under local anaesthesia.
Variation of amount of local anaesthetic	Amount of local anaesthetic consumed for a defined surgical procedure	on the day of surgery under local anaesthesia.
measure of operating time	operating time for a defined surgical procedure.	on the day of surgery under local anaesthesia.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Stéphanie Dakpe, MD, CHU Amiens; Principal Investigator: Jérémie Bettoni, MD, CHU Amiens; Principal Investigator: Bernard Devauchelle, Pr, CHU Amiens; Principal Investigator: Sylvie Testelin, Pr, CHU Amiens; Principal Investigator: Stéphanie Mauquit, N, CHU Amiens

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: hypnosis; outpatient surgery; local anaesthesia; face surgery
• Additional Relevant MeSH Terms: Anesthesia and Analgesia; Anesthesia, Conduction; Anesthesia; Anesthesia, Local
• Other Study ID Numbers: PI2019_843_0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No