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The collaborator has no intention to initiate the study at this moment.
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| Name | Class |
|---|---|
| Nationwide Children's Hospital | OTHER |
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This multi-center, prospective, clinical trial targets recruiting children undergoing inhalational induction of anesthesia. The primary objective of this study is to assess the Modified Yale Preoperative Anxiety Scale during induction between children receiving oral midazolam 0.5 mg/kg (max 20 mg) versus virtual parental presence on induction of anesthesia. Patients will be randomized to one of two groups by block randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Parental Presence on Induction of Anesthesia group | Experimental | Use of Facetime with child and parents during induction |
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| Midazolam Group | Experimental | 0.5 mg/kg oral midazolam (max 20 mg) will be given preoperatively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Parental Presence on Induction of Anesthesia | Behavioral | Apple Inc's FaceTimeâ„¢ video application will be used when the child is taken to the operating room |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of Anxiety in children | We will be using the modified Yale Preoperative Anxiety Scale (mYPAS) which was developed specifically to measure anxiety at anesthesia induction. It looks at activity, facial expression, alertness and arousal, vocalization and interaction with adults. It has a good validity against the State-Trait Anxiety Inventory for Children, as well as good intra and inter-observer reliability. mYPAS contains 5 items (activity, vocalisation, emotional expressivity, state of apparent arousal, and use of parent). The total score ranges from 0 to 22. Higher scores mean higher levels of anxiety. | baseline, immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Induction compliance | The Induction Compliance Checklist (ICC) is a validated observational scale, used to describe the compliance of a child during induction of anesthesia. ICC contains 10 items. Score ranges from 0 to 1. 0 point indicates the behavior is not observed while 1 point means behavior is observed. | immediately during anesthetic induction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa Olbrecht, MD, MBA | Nationwide Children's Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Midazolam | Behavioral | Preoperative midazolam (0.5 mg/kg of oral midazolam with a maximum dose of 20mg) will be given unless medically contraindicated. |
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| Change of parental anxiety | The State-Trait Anxiety Inventory (STAI) is the gold standard for assessing anxiety in adults and has been used in over 1000 studies. It is comprises 20 questions. The total score ranges from 0-63. 0-9 indicates normal or no anxiety; 10-18 indicates mild to moderate anxiety; 19-29 indicates moderate to severe anxiety; and 30-63 indicates severe anxiety. | baseline, immediately after anesthetic induction |
| D006571 | Heterocyclic Compounds |