Study of the Effects of Hypnosis Before Undergoing Surgery, on Anxiety in Children Aged 10 to 18 Years
NCT ID: NCT01320956
Last Updated: 2023-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2011-03-31
2013-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Hypnosis
Pre operative nurse consultation and Hypnosis:
will have hypnosis
Pre operative nurse consultation and Hypnosis
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.
Control
Pre operative nurse consultation:
usual nurse consultation without hypnosis
Pre operative nurse consultation
Pre operative nurse consultation with pain management nurse. Usual care and anesthesia
Interventions
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Pre operative nurse consultation and Hypnosis
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.
Pre operative nurse consultation
Pre operative nurse consultation with pain management nurse. Usual care and anesthesia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Orthopaedics surgery (spinal column, osteotomy)
* ASA 1 \& 2
Exclusion Criteria
* patient or family unable to understand the study (language, disability ...)
* patient or family refusing the study
10 Years
215 Months
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Chantal WOOD, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Robert Debré
Paris, , France
Countries
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References
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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.
Other Identifiers
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2010-A01165-34
Identifier Type: OTHER
Identifier Source: secondary_id
P100112
Identifier Type: -
Identifier Source: org_study_id
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