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Information and Anaesthesia in Paediatrics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00841022
First received: February 10, 2009
Last updated: January 17, 2013
Last verified: December 2010
History of Changes
  Purpose

This study aims to investigate whether detailed and illustrated information (comics) about anaesthesia reduce preoperative anxiety in children being subjects to craniotomy.

Children scheduled for craniotomy are randomized to groups receiving a comic leaflet explaining the course of anaesthesia before preanaesthesia visit or no intervention.

Preoperative anxiety is assessed with anxiety scale STAIC for the two groups of participants.


Condition Intervention
Anxiety
 Other: Information with comics

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Comics on Anaesthesia's Anxiety in Paediatrics: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Level of anxiety scale (STAIC-S) [ Time Frame: before preanaesthesia consultation and after preanaesthesia consultation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Level of verbal comprehension : WISC 4 (similitude, vocabulary and comprehension) [ Time Frame: before preanaesthesia consultation ] [ Designated as safety issue: No ]
  • Level of anxiety scale (STAIC-T) [ Time Frame: Before preanaesthesia consultation ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: February 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Information of children with comic leaflet
 Other: Information with comics
Information of children with comic leaflet
No Intervention: 2

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female children between 6 to 16 years and 11 month old.
  • Children scheduled to have a craniotomy.
  • Children with a high, normal or light level of verbal comprehension (normal academic level or less than two repeating)
  • Children coming with their parents.

Exclusion Criteria:

  • Previous surgery.
  • Unwillingness to participate (parents or child)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841022

Contacts
Contact: Edmundo PEREIRA DE SOUZA NETO, MD 472 118 934 ext +33 edmundo.pereira-de-souza-neto@chu-lyon.fr

Locations
France
Hospices Civils de Lyon Recruiting
Lyon, France, 69 002
Principal Investigator: Edmundo PEREIRA DE SOUZA NETO, MD            
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Edmundo PEREIRA DE SOUZA NETO, MD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00841022     History of Changes
Other Study ID Numbers: 2008.518
Study First Received: February 10, 2009
Last Updated: January 17, 2013
Health Authority: France: Direction Générale de la Santé

Keywords provided by Hospices Civils de Lyon:
anxiety
anaesthesia
child
RCT
Elective craniotomy surgery

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013