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

Hypnosis Clinical Trial

— HYPNOFACE  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03926403
• Other study ID #: PI2019_843_0007
• Status: Recruiting
• Phase: N/A
• Start date: January 28, 2020
• Est. completion date: October 2023

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Martine Gosset, ORN
• Phone: (33)322089050
• Email: gosset.martine[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: October 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• FACE
• Hypnosis
• Local Anaesthesia
• Outpatient Surgery

Intervention

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.
• local anaesthesia
Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from conventional management (local anaesthesia).

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Variation of amount of local anaesthetic	Amount of local anaesthetic consumed for a defined surgical procedure	on the day of surgery under local anaesthesia.
Secondary	measure of operating time	operating time for a defined surgical procedure.	on the day of surgery under local anaesthesia.