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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A00758-47 | Registry Identifier | ID-RCB |
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Unsuccessful study
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LUNII | Other | The interactive story teller LUNII is delivered to the child the day before surgery, during the usual pre-operative medical visit. |
|
| Without LUNII | No Intervention | Usual pre-operative visit. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive story teller LUNII | Behavioral | Use of the interactive story teller LUNII by the child from the pre-operative visit to the discharge. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roman Hossein Khonsari, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Necker-Enfants Malades | Paris | 75015 | France |
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| 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 |
| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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