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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01320956
First received: March 21, 2011
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

This study aims to find how hypnosis performed just before a painful surgery can change anxiety level, in children aged 10 to 18 years.


Condition Intervention
Osteotomy and Spinal Column Surgery
Behavioral: Pre operative nurse consultation and Hypnosis
Other: Pre operative nurse consultation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Impact of Pre Operative Hypnosis on Anxiety in Children Aged 10 to 18 Years

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Level of anxiety at day 1 (24 hours after surgery) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Anxiety level [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    difference in anxiety level between D-1 (the day before surgery) and D1 (24 hours after surgery)

  • Pain after surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    need for analgesics (morphine)


Enrollment: 120
Study Start Date: March 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypnosis

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

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.

  Eligibility

Ages Eligible for Study:   10 Years to 215 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320956

Locations
France
Hôpital Robert Debré
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Chantal WOOD, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01320956     History of Changes
Other Study ID Numbers: P100112, 2010-A01165-34
Study First Received: March 21, 2011
Last Updated: September 17, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
hypnosis
HYPNOANALGESIA
surgery
children
anxiety
morphine
pain
A-VAS
orthopaedics
osteotomy
tenotomy
arthrodesis
spinal column surgery

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 25, 2014