An interventional study of iPad and Standard Care in Anxiety, Laceration Repair and Children, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-07-23.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Supportive care
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.
133 studies on the registry are indexed under Lacerations; 29 are open to participants now.
This study's enrollment of 80 is close to the median of 79 across 106 interventional studies indexed under Lacerations.
Browse Lacerations studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
iPad with age-appropriate applications, videos, and music
Device: iPad · 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).
Other: Standard Care
iPad with age-appropriate applications, videos, and music
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).
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
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
| Milestone | iPad | Standard Care |
|---|---|---|
| Started | 40 | 40 |
| Completed | 39 | 38 |
| Not completed | 1 | 2 |
| Withdrew: Protocol violation | 1 | 1 |
| Withdrew: Incomplete data | 0 | 1 |
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)
| units on a scale | iPad | Standard Care |
|---|---|---|
| Observational Score Behavioral Distress Revised (OSBD-R) | 2.3 (0 to 6.2) | 0.8 (0.1 to 5.5) |
Parent rating of own anxiety during the procedure Likert-based scale 1-5 (1 low/better, 5 high/worse)
| score on a scale | iPad | Standard Care |
|---|---|---|
| Parent Survey | 2 (1 to 4) | 4 (3.8 to 5) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| iPad | — | 0/40 (0%) | 0/40 (0%) |
| Standard Care | — | 0/40 (0%) | 0/40 (0%) |
| Age, Categorical(Participants) | iPad | Standard Care | Total |
|---|---|---|---|
| <=18 years | 39 | 38 | 77 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | iPad | Standard Care | Total |
|---|---|---|---|
| Mean | 5.0 ± 2.5 | 5.5 ± 2.6 | 5.2 ± 2.5 |
| Sex: Female, Male(Participants) | iPad | Standard Care | Total |
|---|---|---|---|
| Female | 15 | 10 | 25 |
| Male | 24 | 28 | 52 |
| Location of laceration(Participants) | iPad | Standard Care | Total |
|---|---|---|---|
| Forehead/eyebrow | 16 | 23 | 39 |
| Lip | 3 | 4 | 7 |
| Chin | 19 | 10 | 29 |
| Other | 1 | 1 | 2 |
| Number of sutures(sutures) | iPad | Standard Care | Total |
|---|---|---|---|
| Mean | 4.0 ± 2.4 | 4.6 ± 2.6 | 4.3 ± 2.5 |
| Duration of procedure(minutes) | iPad | Standard Care | Total |
|---|---|---|---|
| Mean | 15.5 ± 6.5 | 16.4 ± 8.4 | 16.0 ± 7.5 |
| Topical anesthetic(Participants) | iPad | Standard Care | Total |
|---|---|---|---|
| Topical | 37 | 34 | 71 |
| No topical | 2 | 4 | 6 |
| Use of restraint(Participants) | iPad | Standard Care | Total |
|---|---|---|---|
| Count of participants | 20 | 19 | 39 |
3 further baseline measures are reported on the registry.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University of California, San Diego