Information and Anaesthesia in Paediatrics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Information of children with comic leaflet

Group Type EXPERIMENTAL

Information with comics

Intervention Type OTHER

Information of children with comic leaflet

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Information with comics

Information of children with comic leaflet

Intervention Type OTHER

Eligibility Criteria

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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.