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

NCT ID: NCT03926403

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-28
• Study Completion Date: 2023-10-31

Brief 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.

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.

Conditions

Hypnosis; Local Anaesthesia; Outpatient Surgery; FACE

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypnosis

Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on hypnosis techniques.

Group Type: EXPERIMENTAL

State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire")

Intervention Type: OTHER

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).

hypnosis techniques

Intervention Type: PROCEDURE

Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on hypnosis techniques.

conventional management

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

Group Type: ACTIVE_COMPARATOR

State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire")

Intervention Type: OTHER

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).

local anaesthesia

Intervention Type: PROCEDURE

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

Interventions

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).

Intervention Type: OTHER

hypnosis techniques

Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on hypnosis techniques.

Intervention Type: PROCEDURE

local anaesthesia

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernard Devauchelle, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Stéphanie Dakpe, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Sylvie Testelin, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Jérémie Bettoni, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Stéphanie Mauquit, N

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

CHU Amiens Picardie

Amiens, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Martine Gosset, ORN

Role: CONTACT

gosset.martine@chu-amiens.fr

(33)322089050

Facility Contacts

Stéphanie DAKPE, MD

Role: primary

dakpe.stéphanie@chu-amiens.fr

Other Identifiers

PI2019_843_0007

Identifier Type: -

Identifier Source: org_study_id