Trials / Terminated
TerminatedNCT03740841
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
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 4 Years – 6 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Interactive story teller LUNII | Use of the interactive story teller LUNII by the child from the pre-operative visit to the discharge. |
Timeline
- Start date
- 2019-01-08
- Primary completion
- 2019-01-08
- Completion
- 2019-01-08
- First posted
- 2018-11-14
- Last updated
- 2025-09-25
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03740841. Inclusion in this directory is not an endorsement.