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

Pediatric Surgery Clinical Trial

— Anx'Appli  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05401617
• Other study ID #: 2019/087/HP
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 30, 2022
• Est. completion date: February 15, 2024

Study information

• Verified date: May 2022
• Source: University Hospital, Rouen
• Contact: Vincent Compere, Pr
• Phone: +3323288
• Email: vincent.compere[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 352
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pediatric Surgery

Intervention

Other:
• additional information via the computerized tool
additional information delivered via the computerized tool

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of anxiety on entering the operating room	YALE score (also called m-YPAS SF) : 22.9 to 100	15 days
Secondary	Anxiety of parents	EVA (Analogic Visual Scale) score : 0 to 10	15 days
Secondary	Need of an analgesic supplement in SSPI (post-interventional monitoring room)		15 days
Secondary	Duration of stay in SSPI	Stay in SSPI in minutes	15 days
Secondary	Parents' satisfaction with the quality of the information provided	numerical scale : 0 to 10	15 days