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

Osteotomy and Spinal Column Surgery Clinical Trial

— HYPOPANX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320956
• Other study ID #: P100112
• Secondary ID: 2010-A01165-34
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: March 2013

Study information

• Verified date: September 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 215 Months

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Osteotomy and Spinal Column Surgery

Intervention

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:
• Pre operative nurse consultation
Pre operative nurse consultation with pain management nurse. Usual care and anesthesia

Locations

Country	Name	City	State
France	Hôpital Robert Debré	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Duparc-Alegria N, Tiberghien K, Abdoul H, Dahmani S, Alberti C, Thiollier AF. Assessment of a short hypnosis in a paediatric operating room in reducing postoperative pain and anxiety: A randomised study. J Clin Nurs. 2018 Jan;27(1-2):86-91. doi: 10.1111/j — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of anxiety at day 1 (24 hours after surgery)	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	Anxiety level	difference in anxiety level between D-1 (the day before surgery) and D1 (24 hours after surgery)	24 hours
Secondary	Pain after surgery	need for analgesics (morphine)	24 hours