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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A01165-34 | Other Identifier | ID-RCB |
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This study aims to find how hypnosis performed just before a painful surgery can change anxiety level, in children aged 10 to 18 years.
Undergoing surgery can cause anxiety among children. Thus, peri operative anxiety can increase levels of pain, need for painkillers, and even length of stay in hospital.
Caring for children must take in account their anxiety. This anxiety can be treated through drugs or others means such as hypnosis. Thus, the use hypnosis in surgery has been very poorly assessed.
Parents will be given a consent form as well as an information note. This study aims to compare the level of post operative anxiety (D1)of children having hypnosis before receiving anaesthetics to the level of anxiety of children getting the usual care.
All the children included in this study will have a pre operative consultation with the Pain Management Nurse.
The study applies to inpatients, aged 10 to 18 years, who must go through orthopaedics surgery such as osteotomy (bone section) and spinal column surgery. 120 patients will be included in this study (60 in each arm) The primary outcome measure is the level of anxiety at day 1 (24 hours after surgery) Other outcome measure are
Expected impact of this study :change in procedures, decrease of anxiety levels in patients by the use of hypnosis before anaesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypnosis | Experimental | Pre operative nurse consultation and Hypnosis: will have hypnosis |
|
| Control | Active Comparator | Pre operative nurse consultation: usual nurse consultation without hypnosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre operative nurse consultation and Hypnosis | Behavioral | Pre operative nurse consultation with pain management nurse, the day before surgery and 5 to 10 minutes of hypnosis, just before anesthesia, with trained nurse. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of anxiety at day 1 (24 hours after surgery) | Level anxiety will be measured 24 hours after exit of operating room, using A-VAS (Anxiety visual analog scale) by a single blind assessor. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety level | difference in anxiety level between D-1 (the day before surgery) and D1 (24 hours after surgery) | 24 hours |
| Pain after surgery | need for analgesics (morphine) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chantal WOOD, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Robert Debré | Paris | 75019 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28403569 | Result | Duparc-Alegria N, Tiberghien K, Abdoul H, Dahmani S, Alberti C, Thiollier AF. Assessment of a short hypnosis in a paediatric operating room in reducing postoperative pain and anxiety: A randomised study. J Clin Nurs. 2018 Jan;27(1-2):86-91. doi: 10.1111/jocn.13848. Epub 2017 Jul 4. |
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|
| Pre operative nurse consultation | Other | Pre operative nurse consultation with pain management nurse. Usual care and anesthesia |
|
|
| 24 hours |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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