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
- Cleft Lip and Palate
- Interventions
- Behavioral: Interactive story teller LUNII
- Registration Number
- NCT03740841
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LUNII Interactive story teller LUNII The interactive story teller LUNII is delivered to the child the day before surgery, during the usual pre-operative medical visit.
- Primary Outcome Measures
Name Time Method Yale Preoperative Anxiety Scale (mYPAS ) At the time of anesthetic induction 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)
Number of hours spent with the interactive story teller LUNII before surgery Day of surgery (D0) Number of hours spent with the interactive story teller LUNII
- Secondary Outcome Measures
Name Time Method Analgesic administration Up to 1 week Evaluation of analgesic administration after surgery during hospital stay
Visual Analogue pain Scale (EVA) Up to 1 week Self-assessment of pain by a graduated ruler of 0 (no pain) at 100 millimeters (maximum pain imaginable), twice a day during hospitalization
Duration between the operation and the first survey Up to 1 week Duration between the operation and the first survey
Length of hospitalization Up to 1 week Length of hospitalization
Trial Locations
- Locations (1)
Hôpital Necker-Enfants Malades
🇫🇷Paris, France