Information and Anaesthesia in Paediatrics

Civil Hospices of Lyon

Status: Completed

Conditions: Anxiety

Treatments: Other: Information with comics

Study type: Interventional

Funder types: Other

Identifiers

NCT00841022

2008.518

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

115 participants in 2 patient groups

1

Experimental group

Description:

Information of children with comic leaflet

Treatment:

Other: Information with comics

2

No Intervention group