Clinical trial NCT02217436: iPad as a Distraction Tool During Facial Laceration Repair
Official title: iPad as a Distraction Tool During Facial Laceration Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Laceration Repair
Children
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Observational Score Behavioral Distress Revised (OSBD-R)
timeFrame: Entire laceration repair procedure
Secondary outcomes:
measure: Parent Survey
timeFrame: Survey administered immediately following the laceration repair
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
Study officials:
affiliation: University of California, San Diego and Rady Children's Hospital San Diego
name: Bema Bonsu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego and Rady Children's Hospital San Diego
name: Amy Williams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1067/mem.2001.112003.
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.
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. doi: 10.1542/peds.2005-1100.
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. doi: 10.1037//0022-006x.52.6.1106. No abstract available.
citation: 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.