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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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It is a homogeneous population - same condition, same treatment, same age at surgery, standardized procedure;
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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 Design
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- Yale Preoperative Anxiety Scale (mYPAS ) [At the entrance into the operating room]
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)
- Yale Preoperative Anxiety Scale (mYPAS ) [At the time of anesthetic induction]
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)
- Number of hours spent with the interactive story teller LUNII before surgery [Day of surgery (D0)]
Number of hours spent with the interactive story teller LUNII
Secondary Outcome Measures
- Analgesic administration [Up to 1 week]
Evaluation of analgesic administration after surgery during hospital stay
- Visual Analogue pain Scale (EVA) [Up to 1 week]
Self-assessment of pain by a graduated ruler of 0 (no pain) at 100 millimeters (maximum pain imaginable), twice a day during hospitalization
- Duration between the operation and the first survey [Up to 1 week]
Duration between the operation and the first survey
- Length of hospitalization [Up to 1 week]
Length of hospitalization
Eligibility Criteria
Criteria
Inclusion Criteria:
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Children aged 4 to 6 years.
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Alveolar bone graft with iliac crest donor site in children with unilateral or bilateral cleft lip and palate
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Primary alveolar bone graft or first side when bilateral cleft
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Followed at Necker since birth and operated according to the protocol used in the department.
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Consent signed by the holder (or holders) of parental authority
Exclusion Criteria:
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Medical care different from the usual protocol applied in the service (secondary surgery, age > 7 years)
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Known psychomotor delay, associated rare syndrome or disease, known psychiatric disorders, other surgical procedures between hard palate closure and alveolar bone graft
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Possession and/or prior use of LUNII by the child
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Necker-Enfants Malades | Paris | France | 75015 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Roman Hossein Khonsari, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K180306J
- 2018-A00758-47