iPad as a Distraction Tool During Facial Laceration Repair

Study Overview
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Brief Summary
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Children aged 2-12 presenting to the Rady Children's Hospital San Diego (RCHSD) emergency department with facial lacerations requiring suture repair will be eligible to participate in the study. Participating children will be randomized to standard care versus standard care plus iPad use during the procedure. Children's anxiety levels assessed using a validated scale will be measured from video recordings made of the procedure. Parent and provider satisfaction surveys will be completed following the procedure. The primary study aim is to determine how iPad use affects children's anxiety levels during facial laceration repair. The secondary study aim is to determine how iPad use affects parent and provider satisfaction regarding a child's facial laceration repair. Hypothesis is that iPad use decreases children's anxiety levels during facial laceration repair and increases parent and provider satisfaction regarding a child's facial laceration repair.

Official Title
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iPad as a Distraction Tool During Facial Laceration Repair

Conditions
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Anxiety, Laceration Repair, Children

Intervention / Treatment
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* Device: iPad
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients: Male and female children aged 2-12 of all ethnic backgrounds and socioeconomic levels presenting to the emergency department for laceration repair. Children sustaining single, uncomplicated facial lacerations, which can be repaired with basic suture techniques, are eligible for the study. Lacerations repaired using LET cream, lidocaine injection, and LET cream and lidocaine injection are all eligible for the study. Parents of enrolled patients. Providers of enrolled patients: Residents, fellows, attendings, and nurse practitioners serving as the primary provider performing the laceration repair. Exclusion Criteria: Patients: Lacerations to parts of the body other than the face. Children with developmental disabilities. Children with laceration repair requiring sedation. Children with complex lacerations requiring subspecialty repair. Parents and/or providers of children not eligible or enrolled in the study. Providers: Medical students performing the laceration repair.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iPad<br>iPad with age-appropriate applications, videos, and music | Device: iPad<br>* iPad with age-appropriate applications, videos, and music<br>Other: Standard Care<br>* All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).<br>|
| Active Comparator: Standard Care<br>All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization). | Other: Standard Care<br>* All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observational Score Behavioral Distress Revised (OSBD-R) | Weighted average Observational Score Behavioral Distress Revised (OSBD-R) scored from videotapes of the entire laceration repair procedure Scale 0-23.5 (0 low/better, 23.5 high/worse) | Entire laceration repair procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent Survey | Parent rating of own anxiety during the procedure Likert-based scale 1-5 (1 low/better, 5 high/worse) | Survey administered immediately following the laceration repair |