Study of the Effects of Hypnosis Before Undergoing Surgery, on Anxiety in Children Aged 10 to 18 Years

Study Overview
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Brief Summary
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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.

Detailed Description
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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 the difference in anxiety level between D-1 (the day before surgery) and D1 (24 hours after surgery) the use of morphine during the first 24 hours This study is a prospective randomized trial, comparing a usual analgesics procedure to an experimental analgesics procedure including hypnosis before anaesthesia. Expected impact of this study :change in procedures, decrease of anxiety levels in patients by the use of hypnosis before anaesthesia.

Official Title
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Impact of Pre Operative Hypnosis on Anxiety in Children Aged 10 to 18 Years

Conditions
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Osteotomy and Spinal Column Surgery

Intervention / Treatment
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* Behavioral: Pre operative nurse consultation and Hypnosis
* Other: Pre operative nurse consultation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 10-18 years Orthopaedics surgery (spinal column, osteotomy) ASA 1 & 2 Exclusion Criteria: casualty surgery patient or family unable to understand the study (language, disability ...) patient or family refusing the study

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 215 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis<br>Pre operative nurse consultation and Hypnosis: will have hypnosis | Behavioral: Pre operative nurse consultation and Hypnosis<br>* 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.<br>* Other names: Hypnosis, HYPNOANALGESIA;|
| Active Comparator: Control<br>Pre operative nurse consultation: usual nurse consultation without hypnosis | Other: Pre operative nurse consultation<br>* Pre operative nurse consultation with pain management nurse. Usual care and anesthesia<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HYPNOANALGESIA, hypnosis, surgery, children, anxiety, morphine, pain, A-VAS, orthopaedics, osteotomy, tenotomy, arthrodesis, spinal column surgery