Impact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery

Anxiety Clinical Trial

— I-PPOP  

Official title:

Impact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205397
• Other study ID #: I15004
• Status: Completed
• Phase: N/A
• Start date: August 17, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: February 2018
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In France, during surgery, only 4% of parents are present at induction, most often for children with disabilities with iterative interventions. Some studies have shown that the presence of parents during induction decreases the anxiety of children, while others do not. Their conclusions all advocate preparing parents for this presence in the operating room in an accompanying course.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 31, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• 5 to 12 year olds requiring scheduled surgery

• scheduled outpatient or weekly hospitalization.

• Anesthesia envisaged by inhalation induction

• Agreement of parents (and child according to age).

• Even parent (s) present at pre-anesthesia and on the day of surgery

Exclusion Criteria:

• Child with previous surgery

• Parent (s) of a child who has already had surgery

• Parent (s) or child unable to follow the whole procedure (autism, blindness ...)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• Experimental Group
Preparation for anesthesia (explanations, film, booklet), the presence of a parent in the operating room and the awakening of the child
• usual care
Usual care

Locations

Country	Name	City	State
France	CHU de Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of anxiety	Level of anxiety measured at the time of anesthetic induction by the MYPAS hetero-evaluation scale	10 minutes