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

NCT03740841 | Terminated

• 2 other identifiers: K180306J2018-A00758-47
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Lip and Palate

Keywords

Per-operative stress; per-operative anxiety; pediatric surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Analgesic administration

  Up to 1 week

• Visual Analogue pain Scale (EVA)

  Up to 1 week

• Duration between the operation and the first survey

  Up to 1 week

• Length of hospitalization

  Up to 1 week

Study Arms (2)

LUNII

OTHER

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

Without LUNII

NO INTERVENTION

Usual pre-operative visit.

Interventions

Interactive story teller LUNII BEHAVIORAL

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

LUNII

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Roman Hossein Khonsari, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 14, 2018
• Study Start: January 8, 2019
• Primary Completion: January 8, 2019
• Study Completion: January 8, 2019
• Last Updated: September 25, 2025

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)