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iPad as a Distraction Tool During Facial Laceration Repair

Not Applicable
Completed
Conditions
Anxiety
Children
Laceration Repair
Interventions
Device: iPad
Other: Standard Care
Registration Number
NCT02217436
Lead Sponsor
University of California, San Diego
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
Inclusion Criteria
  1. 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.
  2. Parents of enrolled patients.
  3. Providers of enrolled patients: Residents, fellows, attendings, and nurse practitioners serving as the primary provider performing the laceration repair.
Exclusion Criteria
  1. 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.
  2. Parents and/or providers of children not eligible or enrolled in the study.
  3. Providers: Medical students performing the laceration repair.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
iPadStandard CareiPad with age-appropriate applications, videos, and music
Standard CareStandard CareAll 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).
iPadiPadiPad with age-appropriate applications, videos, and music
Primary Outcome Measures
NameTimeMethod
Observational Score Behavioral Distress Revised (OSBD-R)Entire laceration repair procedure

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)

Secondary Outcome Measures
NameTimeMethod
Parent SurveySurvey administered immediately following the laceration repair

Parent rating of own anxiety during the procedure Likert-based scale 1-5 (1 low/better, 5 high/worse)

Trial Locations

Locations (1)

Rady Children's Hospital San Diego

🇺🇸

San Diego, California, United States

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