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 Paris15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cleft Lip and Palate

Interventions

Interactive story teller LUNIIBEHAVIORAL

Use of the interactive story teller LUNII by the child from the pre-operative visit to the discharge.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 6 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Necker-Enfants Malades

Paris, France

Outcomes

Primary Outcomes

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)

Time frame: At the entrance into the operating room

Yale Preoperative Anxiety Scale (mYPAS )

Time frame: 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

Time frame: Day of surgery (D0)

Secondary Outcomes

Analgesic administration

Evaluation of analgesic administration after surgery during hospital stay

Time frame: 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

Time frame: Up to 1 week

Duration between the operation and the first survey

Time frame: Up to 1 week

Length of hospitalization

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.