Clinical trial NCT03740841: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cleft Lip and Palate
Keywords: Per-operative stress
per-operative anxiety
pediatric surgery
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 15
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Yale Preoperative Anxiety Scale (mYPAS )
timeFrame: At the entrance into the operating room
measure: Yale Preoperative Anxiety Scale (mYPAS )
timeFrame: At the time of anesthetic induction
measure: Number of hours spent with the interactive story teller LUNII before surgery
timeFrame: Day of surgery (D0)
Secondary outcomes:
measure: Analgesic administration
timeFrame: Up to 1 week
measure: Visual Analogue pain Scale (EVA)
timeFrame: Up to 1 week
measure: Duration between the operation and the first survey
timeFrame: Up to 1 week
measure: Length of hospitalization
timeFrame: Up to 1 week
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Roman Hossein Khonsari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: