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

NCT03926403 | Unknown

• 1 other identifier: PI2019_843_0007
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypnosis; Local Anaesthesia; Outpatient Surgery; FACE

Keywords

hypnosis; local anaesthesia; outpatient surgery; face surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Value reported by the patient on the Visual Analogue Pain Scale after surgery

  on the day of surgery under local anaesthesia.

• Variation of amount of local anaesthetic

  on the day of surgery under local anaesthesia.

• measure of operating time

  on the day of surgery under local anaesthesia.

Study Arms (2)

Hypnosis

EXPERIMENTAL

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"); Procedure: hypnosis techniques

conventional management

ACTIVE COMPARATOR

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"); Procedure: local anaesthesia

Interventions

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

hypnosis techniques PROCEDURE

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

Hypnosis

local anaesthesia PROCEDURE

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

conventional management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, 80000, France

RECRUITING

MeSH Terms

Interventions

Anesthesia, Local

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Bernard Devauchelle, Pr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Stéphanie Dakpe, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Sylvie Testelin, Pr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Jérémie Bettoni, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Stéphanie Mauquit, N

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martine Gosset, ORN

CONTACT

(33)322089050; gosset.martine@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 24, 2019
• Study Start: January 28, 2020
• Primary Completion: July 1, 2023
• Study Completion: October 1, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)