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

Cleft Lip and Palate Clinical Trial

— LUNII  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03740841
• Other study ID #: K180306J
• Secondary ID: 2018-A00758-47
• Status: Terminated
• Phase: N/A
• Start date: January 8, 2019
• Est. completion date: January 8, 2019

Study information

• Verified date: March 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 8, 2019
• Est. primary completion date: January 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Analgesic administration	Evaluation of analgesic administration after surgery during hospital stay	Up to 1 week
Secondary	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
Secondary	Duration between the operation and the first survey	Duration between the operation and the first survey	Up to 1 week
Secondary	Length of hospitalization	Length of hospitalization	Up to 1 week