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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

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

Clinicaltrials.gov identifier NCT03926403

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted July 22, 2020

Study Description

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.

  • Condition or Disease:Hypnosis
    Local Anaesthesia
    Outpatient Surgery
    FACE
  • Intervention/Treatment: Procedure: local anaesthesia
    Other: State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire")
    Procedure: hypnosis techniques
  • Phase: N/A
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 moderately anxious about their management (score ≥ 46). The latter will be randomized into 2 groups, one benefiting from experimental management based on hypnosis techniques and the other benefiting from conventional management.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 66 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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.
  • Actual Study Start Date: January 2020
  • Estimated Primary Completion Date: January 2022
  • Estimated Study Completion Date: April 2022
Arms and interventions
Arm Intervention/treatment
Experimental: Hypnosis
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")
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 moderately anxious about their management (score ≥ 46).

Procedure: hypnosis techniques
Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on hypnosis techniques.
Active Comparator: conventional management
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")
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 moderately anxious about their management (score ≥ 46).

Procedure: local anaesthesia
Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from conventional management (local anaesthesia).
Outcome Measures
  • Primary Outcome Measures: 1. variation in Spielberger's anxiety self-assessment questionnaire score between the patient's arrival in the operating room and his departure [ Time Frame: on the day of surgery under local anaesthesia. ]
    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.
  • Secondary Outcome Measures: 1. Value reported by the patient on the Visual Analogue Pain Scale after surgery [ Time Frame: on the day of surgery under local anaesthesia. ]
    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."
  • 2. Variation of amount of local anaesthetic [ Time Frame: on the day of surgery under local anaesthesia. ]
    Amount of local anaesthetic consumed for a defined surgical procedure
  • 3. measure of operating time [ Time Frame: on the day of surgery under local anaesthesia. ]
    operating time for a defined surgical procedure.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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 ≥ 46 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

Contacts and Locations
Contacts

Contact: Martine Gosset, ORN (33)322089050 gosset.martine@chu-amiens.fr

Locations

France
CHU Amiens Picardie
Amiens

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

Principal Investigator: Stéphanie Mauquit, N CHU Amiens

Principal Investigator: Jérémie Bettoni, MD CHU Amiens

Principal Investigator: Sylvie Testelin, Pr CHU Amiens

Principal Investigator: Bernard Devauchelle, Pr CHU Amiens

Principal Investigator: Stéphanie Dakpe, MD CHU Amiens

More Information
  • Responsible Party: Centre Hospitalier Universitaire, Amiens
  • ClinicalTrials.gov Identifier: NCT03926403 History of Changes
  • Other Study ID Numbers: PI2019_843_0007
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: July 22, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Centre Hospitalier Universitaire, Amiens: hypnosis
    local anaesthesia
    outpatient surgery
    face surgery