Impact of an Information Assistance Application in Addition to a Traditional Anesthesia Consultation on Preoperative Anxiety in Pediatrics: Prospective Randomized Trial

NCT05401617 | Terminated

• 1 other identifier: 2019/0087/HP
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to evaluate the benefits on pre-operative anxiety of an information assistance application in addition to a traditional anesthesia consultation on preoperative anxiety in pediatrics

Conditions

Pediatric Surgery

Outcome Measures

Primary Outcomes (1)

• Level of anxiety on entering the operating room

  YALE score (also called m-YPAS SF) : 22.9 to 100

  15 days

Secondary Outcomes (4)

• Anxiety of parents

  15 days

• Need of an analgesic supplement in SSPI (post-interventional monitoring room)

  15 days

• Duration of stay in SSPI

  15 days

• Parents' satisfaction with the quality of the information provided

  15 days

Study Arms (2)

control group

NO INTERVENTION

patient benefiting from a traditional anesthesia consultation as performed daily in the department (control group). The information will be delivered according to local customs and the MAR: oral, which can be supplemented by the delivery of the SPARADRAP booklet and the written documents usually delivered

experimental group

EXPERIMENTAL

patient benefiting, in addition to this traditional anesthesia consultation, from additional information via the computerized tool. The operation of this tool will be explained by paramedical staff and its access will be free as soon as you leave the consultation.

Other: additional information via the computerized tool

Interventions

additional information via the computerized tool OTHER

additional information delivered via the computerized tool

experimental group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child between 4 years old (inclusive) and 10 years old (inclusive);
• Must benefit from programmed general anesthesia for scheduled surgery at the Rouen University Hospital, in the paediatrics ward;
• Benefiting from a social security scheme;
• Whose parental authority has consented to participation in the research;
• Not having expressed their refusal to participate in the research;
• Understanding French;
• Ability to access the application being researched.

You may not qualify if:

• Patient with cognitive disorders: disorders known in the history and assessed or suspected during the anesthesia consultation.
• Poor understanding of oral French by the child;
• Poor understanding of the oral and/or written French language by the parent/legal representative;
• Patient presenting a contraindication to general anesthesia or to the intervention during the pre-anaesthetic visit;
• Patient with severe psychiatric disorders

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

UHRouen

Rouen, France

Location

Study Officials

• Vincent Compere

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: June 2, 2022
• Study Start: May 12, 2021
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (1)