iPad as a Distraction Tool During Facial Laceration Repair

Anxiety Clinical Trial

Official title:

iPad as a Distraction Tool During Facial Laceration Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217436
• Other study ID #: iPadWilliams
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Children
• Laceration Repair
• Lacerations

Intervention

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).

Locations

Country	Name	City	State
United States	Rady Children's Hospital San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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