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 (LUNII)

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.

Study Overview

• Status: Terminated
• Conditions: Cleft Lip and Palate
• Intervention / Treatment: Behavioral: Interactive story teller LUNII

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hopital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LUNII; 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; Use of the interactive story teller LUNII by the child from the pre-operative visit to the discharge.
No Intervention: Without LUNII; Usual pre-operative visit.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Roman Hossein Khonsari, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Actual): January 8, 2019
• Study Completion (Actual): January 8, 2019

Study Registration Dates

• First Submitted: November 2, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: pediatric surgery; Per-operative stress; per-operative anxiety
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: K180306J; 2018-A00758-47 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No