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Information and Anaesthesia in Paediatrics

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Information with comics
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring anxiety, anaesthesia, child, RCT, Elective surgery

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female children between 6 to 16 years and 11 month old.
  • Children scheduled to have a craniotomy or orthopaedic surgery (multi-level surgery, spinal decompression, osteosarcoma resection, column surgery , fibroid curettage, Nuss bar procedure, hip varus surgery) or visceral and urologic surgery (intestinal continuity restoration, hypospadias surgery, bladder malformation, sarcoma).
  • 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)

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Information of children with comic leaflet

Outcomes

Primary Outcome Measures

Level of anxiety scale (STAIC-S)

Secondary Outcome Measures

Level of verbal comprehension : WISC 4 (similitude, vocabulary and comprehension)
Level of anxiety scale (STAIC-T)

Full Information

First Posted
February 10, 2009
Last Updated
May 23, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT00841022
Brief Title
Information and Anaesthesia in Paediatrics
Official Title
Effects of Comics on Anaesthesia's Anxiety in Paediatrics: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
anxiety, anaesthesia, child, RCT, Elective surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Information of children with comic leaflet
Arm Title
2
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Information with comics
Intervention Description
Information of children with comic leaflet
Primary Outcome Measure Information:
Title
Level of anxiety scale (STAIC-S)
Time Frame
before preanaesthesia consultation and after preanaesthesia consultation
Secondary Outcome Measure Information:
Title
Level of verbal comprehension : WISC 4 (similitude, vocabulary and comprehension)
Time Frame
before preanaesthesia consultation
Title
Level of anxiety scale (STAIC-T)
Time Frame
Before preanaesthesia consultation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female children between 6 to 16 years and 11 month old. Children scheduled to have a craniotomy or orthopaedic surgery (multi-level surgery, spinal decompression, osteosarcoma resection, column surgery , fibroid curettage, Nuss bar procedure, hip varus surgery) or visceral and urologic surgery (intestinal continuity restoration, hypospadias surgery, bladder malformation, sarcoma). 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmundo PEREIRA DE SOUZA NETO, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69002
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27317708
Citation
Kassai B, Rabilloud M, Dantony E, Grousson S, Revol O, Malik S, Ginhoux T, Touil N, Chassard D, Pereira de Souza Neto E. Introduction of a paediatric anaesthesia comic information leaflet reduced preoperative anxiety in children. Br J Anaesth. 2016 Jul;117(1):95-102. doi: 10.1093/bja/aew154.
Results Reference
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Information and Anaesthesia in Paediatrics

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