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

February 3, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Hopital Robert Debre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety level
Time Frame: 24 hours
difference in anxiety level between D-1 (the day before surgery) and D1 (24 hours after surgery)
24 hours
Pain after surgery
Time Frame: 24 hours
need for analgesics (morphine)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Chantal WOOD, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

March 21, 2011

First Submitted That Met QC Criteria

March 21, 2011

First Posted (ESTIMATE)

March 23, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P100112
  • 2010-A01165-34 (OTHER: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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