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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypnosis | Experimental | Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | on the day of surgery under local anaesthesia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martine Gosset, ORN | Contact | (33)322089050 | gosset.martine@chu-amiens.fr |
| Name | Affiliation | Role |
|---|---|---|
| Bernard Devauchelle, Pr | CHU Amiens | Principal Investigator |
| Stéphanie Dakpe, MD | CHU Amiens | Principal Investigator |
| Sylvie Testelin, Pr |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie | Recruiting | Amiens | 80000 | France |
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| hypnosis techniques | Procedure | Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on hypnosis techniques. |
|
| local anaesthesia | Procedure | Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from conventional management (local anaesthesia). |
|
| Variation of amount of local anaesthetic | Amount of local anaesthetic consumed for a defined surgical procedure | on the day of surgery under local anaesthesia. |
| measure of operating time | operating time for a defined surgical procedure. | on the day of surgery under local anaesthesia. |
| CHU Amiens |
| Principal Investigator |
| Jérémie Bettoni, MD | CHU Amiens | Principal Investigator |
| Stéphanie Mauquit, N | CHU Amiens | Principal Investigator |
| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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