Clinical trial NCT03926403: Evaluation of the Effectiveness of Hypnosis Support on Patient Perception of Outpatient Surgery Under Local Anaesthesia
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypnosis
Local Anaesthesia
Outpatient Surgery
FACE
Keywords: hypnosis
local anaesthesia
outpatient surgery
face surgery
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Value reported by the patient on the Visual Analogue Pain Scale after surgery
timeFrame: on the day of surgery under local anaesthesia.
measure: Variation of amount of local anaesthetic
timeFrame: on the day of surgery under local anaesthesia.
measure: measure of operating time
timeFrame: on the day of surgery under local anaesthesia.
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
affiliation: CHU Amiens
name: Bernard Devauchelle, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Stéphanie Dakpe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Sylvie Testelin, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Jérémie Bettoni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Stéphanie Mauquit, N
role: PRINCIPAL_INVESTIGATOR
References: