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

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Outpatient Surgery; Hypnosis; Local Anaesthesia; FACE

Treatments: Procedure: hypnosis techniques; Procedure: local anaesthesia; Other: State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire")

Study type: Interventional

Funder types: Other

Identifiers

NCT03926403

PI2019_843_0007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Hypnosis

Experimental group

Description:

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

Treatment:

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

Procedure: hypnosis techniques

conventional management

Active Comparator group

Description:

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

Treatment:

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

Procedure: local anaesthesia