iPad as a Distraction Tool During Facial Laceration Repair

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Anxiety Laceration Repair Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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iPad

iPad with age-appropriate applications, videos, and music

Group Type EXPERIMENTAL

iPad

Intervention Type DEVICE

iPad with age-appropriate applications, videos, and music

Standard Care

Intervention Type OTHER

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).

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).

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type OTHER

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).

Interventions

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iPad

iPad with age-appropriate applications, videos, and music

Intervention Type DEVICE

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).

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No