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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Other: Experimental Group; Other: usual care

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87 042
    • Chu de Limoges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 ...)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accompanying and information procedure; Preparation for anesthesia (explanations, film, booklet), the presence of a relative in the operating room and the awakening of the child.	Other: Experimental Group; Preparation for anesthesia (explanations, film, booklet), the presence of a parent in the operating room and the awakening of the child
Other: Usual care; Consultation of anesthesia and the care of the child without parental presence	Other: usual care; Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of anxiety	Level of anxiety measured at the time of anesthetic induction by the MYPAS hetero-evaluation scale	10 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2018
• Last Update Submitted That Met QC Criteria: October 31, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: I15004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No