Impact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery
I-PPOP
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable anxiety
Started Aug 2017
Typical duration for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedStudy Start
First participant enrolled
August 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2018
CompletedMarch 27, 2026
February 1, 2018
1.1 years
June 29, 2017
March 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Level of anxiety
Level of anxiety measured at the time of anesthetic induction by the MYPAS hetero-evaluation scale
10 minutes
Study Arms (2)
Accompanying and information procedure
EXPERIMENTALPreparation for anesthesia (explanations, film, booklet), the presence of a relative in the operating room and the awakening of the child.
Usual care
OTHERConsultation of anesthesia and the care of the child without parental presence
Interventions
Preparation for anesthesia (explanations, film, booklet), the presence of a parent in the operating room and the awakening of the child
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 ...)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Limoges
Limoges, 87 042, France
Related Publications (1)
Peggy BOURNEIX, Pascale BELONI, Noemie MARCHAT, Anaïs LABRUNIE, Valérie DELAIDE, Pierre-Marie PREUX et Jean TONIOLO ; Impact of a preoperative child-parent accompaniment procedure on the anxiety of children aged 5 to 12 with scheduled surgery: a pilot comparative randomized trial.;Recherche et Avancées en Sciences Infirmières ; 10 février 2025
RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2017
First Posted
July 2, 2017
Study Start
August 17, 2017
Primary Completion
September 30, 2018
Study Completion
October 31, 2018
Last Updated
March 27, 2026
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share