Clinical trial · Interventional
Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room
NCT04252508CI-TRIAL-00115636VERAPOPcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Preoperative anxiety affects 40 to 60% of children. A literature review concluded that effective preparation strategies must involve parents, must be appropriate to their age and proposed upstream of the intervention. A double-readinganimated film aimed at informative was created for the children and their parents/legal guardians in order to solve the problem of anxiety found at the arrival of children in the operating room.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Animated film | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- With animated film
- description
- An animated film depicts the child and the caregivers in the form of avatars and retraces his journey from his room to the transfer area, then to the the operating room and finally to the post-intervention ward.
- interventionNames
- Other: Animated film
- type
- NO_INTERVENTION
- label
- Standard route
- description
- The information about the surgery will be given by the surgeon during the consultation. Those about anaesthesia will be delivered by anaesthesiologist during the anaesthetic consultation.
Primary outcomes (1)
- measure
- the child's anxiety score obtained from the M-Ypass scale at the time of induction in the operating room.
- timeFrame
- The duration of this visit will be about 3 hours, between the reception at the outpatient and the time of induction in intervention room, end of the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 7 Years
Show eligibility criteria text
Inclusion Criteria: * Child boy or girl. * 3 to 7 years old. * programmed for: removal of tonsils, vegetations, paracentesis or installation of trans-tympanic aerators, pre-heliceal fistula, otoplasty, myringoplasty * Scheduled intervention in the outpatient department of specialized surgeries or hospitalization of a postoperative night. * Accompanied by an adult, French-speaking, whose child lives at home. * Of which the holders of the parental authority formulated their non-opposition to the participation of their child and gave their signed agreement for the realization of videos of their child. * Assent of the child for children aged 6 to 7 * Parents affiliated to social security For the group under study only: \- Support available at home that can watch the movie on the internet Exclusion Criteria: * Child having already had surgery. * Presence of associated disability (blindness, profound deafness, autistic disorders). * Child having anxiolytic treatment. * Child to be operated within less than 2 days
References
Publications (0)
Data not yet available
No reference posted for this study.