iPad as a Distraction Tool During Facial Laceration Repair

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Children; Laceration Repair
• Intervention / Treatment: Device: iPad; Other: Standard Care

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Rady Children's Hospital San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iPad; iPad with age-appropriate applications, videos, and music	Device: iPad; iPad with age-appropriate applications, videos, and music; Other: Standard Care; 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).
Active Comparator: Standard Care; 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; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Bema Bonsu, MD, University of California, San Diego and Rady Children's Hospital San Diego; Principal Investigator: Amy Williams, MD, University of California, San Diego and Rady Children's Hospital San Diego

Publications and helpful links

General Publications

• Crellin D, Sullivan TP, Babl FE, O'Sullivan R, Hutchinson A. Analysis of the validation of existing behavioral pain and distress scales for use in the procedural setting. Paediatr Anaesth. 2007 Aug;17(8):720-33. doi: 10.1111/j.1460-9592.2007.02218.x.
• Sinha M, Christopher NC, Fenn R, Reeves L. Evaluation of nonpharmacologic methods of pain and anxiety management for laceration repair in the pediatric emergency department. Pediatrics. 2006 Apr;117(4):1162-8. doi: 10.1542/peds.2005-1100.
• Luhmann JD, Kennedy RM, Porter FL, Miller JP, Jaffe DM. A randomized clinical trial of continuous-flow nitrous oxide and midazolam for sedation of young children during laceration repair. Ann Emerg Med. 2001 Jan;37(1):20-7. doi: 10.1067/mem.2001.112003.
• McQueen A, Cress C, Tothy A. Using a tablet computer during pediatric procedures: a case series and review of the "apps". Pediatr Emerg Care. 2012 Jul;28(7):712-4. doi: 10.1097/PEC.0b013e31825d24eb.
• Jay SM, Elliott C. Behavioral observation scales for measuring children's distress: the effects of increased methodological rigor. J Consult Clin Psychol. 1984 Dec;52(6):1106-7. doi: 10.1037//0022-006x.52.6.1106. No abstract available.
• Bryl AW, Bonsu B, Johnson AL, Pommert KBJ, Hollenbach KA, Kanegaye JT. Tablet Computer as a Distraction Tool During Facial Laceration Repair: A Randomized Trial. Pediatr Emerg Care. 2021 Aug 1;37(8):e425-e430. doi: 10.1097/PEC.0000000000001626.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: August 8, 2014
• First Submitted That Met QC Criteria: August 14, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations
• Other Study ID Numbers: iPadWilliams