Hôpital Robert Debré
Paris, 75019, France
NCT Number: NCT01320956
This study aims to find how hypnosis performed just before a painful surgery can change anxiety level, in children aged 10 to 18 years.
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Notify Me10 year–215 month
All sexes
Interventional
Not applicable
Paris, 75019, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: Hypnosis, HYPNOANALGESIA
Pre operative nurse consultation with pain management nurse. Usual care and anesthesia
Other names: Control
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.
Time frame: 24 hours
difference in anxiety level between D-1 (the day before surgery) and D1 (24 hours after surgery)
Time frame: 24 hours
need for analgesics (morphine)
Assistance Publique - Hôpitaux de Paris
Other
Impact of Pre Operative Hypnosis on Anxiety in Children Aged 10 to 18 Years
Acronym: HYPOPANX
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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