Study of the Effects of Hypnosis Before Undergoing Surgery, on Anxiety in Children Aged 10 to 18 Years (HYPOPANX)
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|ClinicalTrials.gov Identifier: NCT01320956|
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : November 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Osteotomy and Spinal Column Surgery||Behavioral: Pre operative nurse consultation and Hypnosis Other: Pre operative nurse consultation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Impact of Pre Operative Hypnosis on Anxiety in Children Aged 10 to 18 Years|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Pre operative nurse consultation and Hypnosis:
will have hypnosis
Behavioral: 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.
Other Name: Hypnosis, HYPNOANALGESIA
Active Comparator: Control
Pre operative nurse consultation:
usual nurse consultation without hypnosis
Other: Pre operative nurse consultation
Pre operative nurse consultation with pain management nurse. Usual care and anesthesia
Other Name: Control
- Level of anxiety at day 1 (24 hours after surgery) [ Time Frame: 24 hours ]Level anxiety will be measured 24 hours after exit of operating room, using A-VAS (Anxiety visual analog scale) by a single blind assessor.
- Anxiety level [ Time Frame: 24 hours ]difference in anxiety level between D-1 (the day before surgery) and D1 (24 hours after surgery)
- Pain after surgery [ Time Frame: 24 hours ]need for analgesics (morphine)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320956
|Hôpital Robert Debré|
|Paris, France, 75019|
|Principal Investigator:||Chantal WOOD, MD||Assistance Publique - Hôpitaux de Paris|