Anxiety, Laceration Repair, Children
Conditions
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.
Interventions
DEVICEiPad
iPad with age-appropriate applications, videos, and music
OTHERStandard 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).
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observational Score Behavioral Distress Revised (OSBD-R) | Entire laceration repair procedure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent Survey | Survey administered immediately following the laceration repair | Parent rating of own anxiety during the procedure Likert-based scale 1-5 (1 low/better, 5 high/worse) |
Countries
United States
Participant flow
Pre-assignment details
105 eligible patients were approached and 25 refused to participate in the study (not consented), 80 participants were randomized, and 3 withdrew from the study.
Participants by arm
| Arm | Count |
|---|---|
| iPad iPad + Standard Care
iPad: iPad with age-appropriate applications, videos, and music
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). | 39 |
| Standard Care Standard Care
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). | 38 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incomplete data | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Standard Care | Total | iPad |
|---|---|---|---|
| Age, Categorical <=18 years | 38 Participants | 77 Participants | 39 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.5 years STANDARD_DEVIATION 2.6 | 5.2 years STANDARD_DEVIATION 2.5 | 5.0 years STANDARD_DEVIATION 2.5 |
| Buffered with bicarbonate | 7 Participants | 11 Participants | 4 Participants |
| Duration of procedure | 16.4 minutes STANDARD_DEVIATION 8.4 | 16.0 minutes STANDARD_DEVIATION 7.5 | 15.5 minutes STANDARD_DEVIATION 6.5 |
| Infiltrated anesthetic | 30 Participants | 60 Participants | 30 Participants |
| Location of laceration Chin | 10 Participants | 29 Participants | 19 Participants |
| Location of laceration Forehead/eyebrow | 23 Participants | 39 Participants | 16 Participants |
| Location of laceration Lip | 4 Participants | 7 Participants | 3 Participants |
| Location of laceration Other | 1 Participants | 2 Participants | 1 Participants |
| Number of sutures | 4.6 sutures STANDARD_DEVIATION 2.6 | 4.3 sutures STANDARD_DEVIATION 2.5 | 4.0 sutures STANDARD_DEVIATION 2.4 |
| Sex: Female, Male Female | 10 Participants | 25 Participants | 15 Participants |
| Sex: Female, Male Male | 28 Participants | 52 Participants | 24 Participants |
| Topical anesthetic No topical | 4 Participants | 6 Participants | 2 Participants |
| Topical anesthetic Topical | 34 Participants | 71 Participants | 37 Participants |
| Type of provider Emergency medicine | 2 Participants | 4 Participants | 2 Participants |
| Type of provider Fellow | 7 Participants | 11 Participants | 4 Participants |
| Type of provider Nurse practitioner | 5 Participants | 11 Participants | 6 Participants |
| Type of provider Pediatric emergency medicine | 15 Participants | 27 Participants | 12 Participants |
| Type of provider Pediatrics | 5 Participants | 13 Participants | 8 Participants |
| Type of provider Resident | 4 Participants | 11 Participants | 7 Participants |
| Use of restraint | 19 Participants | 39 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
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)
Time frame: Entire laceration repair procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| iPad | Observational Score Behavioral Distress Revised (OSBD-R) | 2.3 units on a scale |
| Standard Care | Observational Score Behavioral Distress Revised (OSBD-R) | 0.8 units on a scale |
p-value: 0.98Wilcoxon (Mann-Whitney)
Secondary
Parent Survey
Parent rating of own anxiety during the procedure Likert-based scale 1-5 (1 low/better, 5 high/worse)
Time frame: Survey administered immediately following the laceration repair
Population: Parent own anxiety survey
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| iPad | Parent Survey | 2 score on a scale |
| Standard Care | Parent Survey | 4 score on a scale |
p-value: 0.01Wilcoxon (Mann-Whitney)