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

Assistance Publique - Hôpitaux de Paris

Status

Terminated

Conditions

Cleft Lip and Palate

Treatments

Behavioral: Interactive story teller LUNII

Study type

Interventional

Funder types

Other

Identifiers

NCT03740841

K180306J

2018-A00758-47 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

15 patients

Sex

All

Ages

4 to 6 years old

Volunteers

No Healthy Volunteers

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