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Evaluation of the Effects of LUNII on Pre-operative Anxiety and on the Post-operative Period in Children With Cleft Lip and Palate Admitted for Alveolar Bone Graft: Pilot Study

NCT03740841 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-09-25

No results posted yet for this study

Summary

The literature on the effects of various devices on per-operative anxiety is scarce. There is currently no study on the effects of an interactive storyteller on per-operative anxiety in pediatric surgery.

The interactive story teller LUNII (available over the counter in France) would reduce pre-operative anxiety, with post-operative effects on pain and hospitalization time.

Conditions

  • Cleft Lip and Palate

Interventions

BEHAVIORAL

Interactive story teller LUNII

Use of the interactive story teller LUNII by the child from the pre-operative visit to the discharge.

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Roman Hossein Khonsari, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-08
Primary Completion
2019-01-08
Completion
2019-01-08

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03740841 on ClinicalTrials.gov