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

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ClinicalTrials.gov Identifier: NCT03926403
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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 Intervention/treatment Phase
Hypnosis Local Anaesthesia Outpatient Surgery FACE Other: State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire") Procedure: hypnosis techniques Procedure: local anaesthesia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 28, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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).




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926403


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

Locations
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France
CHU Amiens Picardie Recruiting
Amiens, France, 80000
Contact: Stéphanie DAKPE, MD       dakpe.stéphanie@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: 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
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03926403    
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

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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
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs