Back to resultsImpact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery (I-PPOP)
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Experimental Group
usual care
Sponsored by
About this trial
This is an interventional other trial for Anxiety
Eligibility Criteria
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 ...)
Sites / Locations
- CHU de Limoges
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Accompanying and information procedure
Usual care
Arm Description
Preparation for anesthesia (explanations, film, booklet), the presence of a relative in the operating room and the awakening of the child.
Consultation of anesthesia and the care of the child without parental presence
Outcomes
Primary Outcome Measures
Level of anxiety
Level of anxiety measured at the time of anesthetic induction by the MYPAS hetero-evaluation scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03205397
First Posted
June 29, 2017
Last Updated
October 31, 2018
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT03205397
Brief Title
Impact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery
Acronym
I-PPOP
Official Title
Impact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 17, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Accompanying and information procedure
Arm Type
Experimental
Arm Description
Preparation for anesthesia (explanations, film, booklet), the presence of a relative in the operating room and the awakening of the child.
Arm Title
Usual care
Arm Type
Other
Arm Description
Consultation of anesthesia and the care of the child without parental presence
Intervention Type
Other
Intervention Name(s)
Experimental Group
Intervention Description
Preparation for anesthesia (explanations, film, booklet), the presence of a parent in the operating room and the awakening of the child
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
Level of anxiety
Description
Level of anxiety measured at the time of anesthetic induction by the MYPAS hetero-evaluation scale
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 ...)
Facility Information:
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87 042
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery
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