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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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 techniques

    Procedure/Surgery

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

  • local anaesthesia

    Procedure/Surgery

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

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: HypnosisExperimental treatment 2 interventions
Group B: conventional managementActive comparator 2 interventions

Trial outcomes

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.

Time frame
on the day of surgery under local anaesthesia.

Secondary outcomes

1

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

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."

Time frame
on the day of surgery under local anaesthesia.
2

Variation of amount of local anaesthetic

Amount of local anaesthetic consumed for a defined surgical procedure

Time frame
on the day of surgery under local anaesthesia.
3

measure of operating time

operating time for a defined surgical procedure.

Time frame
on the day of surgery under local anaesthesia.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.