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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 — LUNII  

Cleft Lip and Palate Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

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. Patients admitted for an alveolar bone graft with an iliac donor site as part of the treatment of their cleft lip and palate will be include for two reasons: 1. It is a homogeneous population - same condition, same treatment, same age at surgery, standardized procedure; 2. It is a population with long individual medical histories and, potentially, subjected to significant surgery-related stress. Patients will be randomized into two groups: with LUNII and without LUNII. In the LUNII group, the interactive story teller LUNII will be delivered the day before surgery during the pre-operative medical visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03740841
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Terminated
Phase N/A
Start date January 8, 2019
Completion date January 8, 2019
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