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Completed

NCT Number: NCT01320956

Study of the Effects of Hypnosis Before Undergoing Surgery, 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.

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Key information

Age range

10 year–215 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Robert Debré

Paris, 75019, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre operative nurse consultation and Hypnosis

Behavioral

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

Other

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

Other names: Control

Primary outcomes

  1. 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

  1. Anxiety level

    Time frame: 24 hours

    difference in anxiety level between D-1 (the day before surgery) and D1 (24 hours after surgery)

  2. Pain after surgery

    Time frame: 24 hours

    need for analgesics (morphine)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: HYPOPANX

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 23, 2011
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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