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Clinical Trials/NCT01320956
NCT01320956
Completed
N/A

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country120 target enrollmentMarch 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteotomy and Spinal Column Surgery
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
120
Locations
1
Primary Endpoint
Level of anxiety at day 1 (24 hours after surgery)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
March 2013
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Anxiety level(24 hours)
  • Pain after surgery(24 hours)

Study Sites (1)

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