N/A
N=80
iPad as a Distraction Tool During Facial Laceration Repair
Anxiety · Laceration Repair · Children
Bottom Line
View on ClinicalTrials.gov: NCT02217436 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Observational Score Behavioral Distress Revised (OSBD-R) — 2.3; 0.8 units on a scale — p=0.98
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- iPad (Device); Standard Care (Other)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Observational Score Behavioral Distress Revised (OSBD-R) |
2.3; 0.8 | 0.98 |
| SECONDARY Parent Survey |
2; 4 | 0.01 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02217436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.