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

Study Overview
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Brief Summary
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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
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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: It is a homogeneous population - same condition, same treatment, same age at surgery, standardized procedure; 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.

Official Title
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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

Conditions
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Cleft Lip and Palate

Intervention / Treatment
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* Behavioral: Interactive story teller LUNII


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 4 to 6 years. Alveolar bone graft with iliac crest donor site in children with unilateral or bilateral cleft lip and palate Primary alveolar bone graft or first side when bilateral cleft Followed at Necker since birth and operated according to the protocol used in the department. Consent signed by the holder (or holders) of parental authority Exclusion Criteria: Medical care different from the usual protocol applied in the service (secondary surgery, age > 7 years) Known psychomotor delay, associated rare syndrome or disease, known psychiatric disorders, other surgical procedures between hard palate closure and alveolar bone graft Possession and/or prior use of LUNII by the child

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LUNII<br>The interactive story teller LUNII is delivered to the child the day before surgery, during the usual pre-operative medical visit. | Behavioral: Interactive story teller LUNII<br>* Use of the interactive story teller LUNII by the child from the pre-operative visit to the discharge.<br>|
| No Intervention: Without LUNII<br>Usual pre-operative visit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale Preoperative Anxiety Scale (mYPAS ) | Questionnaire, completed in the operating room by an independent observer preferably without knowledge about the child, made of 22 items divided into 5 categories. The score ranges from 5 (minimum anxiety) to 20 (maximum anxiety) | At the entrance into the operating room | 
| Yale Preoperative Anxiety Scale (mYPAS ) | Questionnaire, completed in the operating room by an independent observer preferably without knowledge about the child, made of 22 items divided into 5 categories. The score ranges from 5 (minimum anxiety) to 20 (maximum anxiety) | At the time of anesthetic induction | 
| Number of hours spent with the interactive story teller LUNII before surgery | Number of hours spent with the interactive story teller LUNII | Day of surgery (D0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic administration | Evaluation of analgesic administration after surgery during hospital stay | Up to 1 week | 
| Visual Analogue pain Scale (EVA) | Self-assessment of pain by a graduated ruler of 0 (no pain) at 100 millimeters (maximum pain imaginable), twice a day during hospitalization | Up to 1 week | 
| Duration between the operation and the first survey | Duration between the operation and the first survey | Up to 1 week | 
| Length of hospitalization | Length of hospitalization | Up to 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Per-operative stress, per-operative anxiety, pediatric surgery