Trial Outcomes & Findings for iPad as a Distraction Tool During Facial Laceration Repair (NCT NCT02217436)
NCT ID: NCT02217436
Last Updated: 2019-07-23
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Entire laceration repair procedure
Results posted on
2019-07-23
Participant Flow
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.
Participant milestones
| Measure |
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).
|
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).
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).
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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).
|
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).
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).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Incomplete data
|
0
|
1
|
Baseline Characteristics
iPad as a Distraction Tool During Facial Laceration Repair
Baseline characteristics by cohort
| Measure |
iPad
n=39 Participants
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).
|
Standard Care
n=38 Participants
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).
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
39 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
5.0 years
STANDARD_DEVIATION 2.5 • n=99 Participants
|
5.5 years
STANDARD_DEVIATION 2.6 • n=107 Participants
|
5.2 years
STANDARD_DEVIATION 2.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Location of laceration
Forehead/eyebrow
|
16 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Location of laceration
Lip
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Location of laceration
Chin
|
19 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Location of laceration
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Number of sutures
|
4.0 sutures
STANDARD_DEVIATION 2.4 • n=99 Participants
|
4.6 sutures
STANDARD_DEVIATION 2.6 • n=107 Participants
|
4.3 sutures
STANDARD_DEVIATION 2.5 • n=206 Participants
|
|
Duration of procedure
|
15.5 minutes
STANDARD_DEVIATION 6.5 • n=99 Participants
|
16.4 minutes
STANDARD_DEVIATION 8.4 • n=107 Participants
|
16.0 minutes
STANDARD_DEVIATION 7.5 • n=206 Participants
|
|
Topical anesthetic
Topical
|
37 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Topical anesthetic
No topical
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Use of restraint
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Type of provider
Pediatric emergency medicine
|
12 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Type of provider
Pediatrics
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Type of provider
Emergency medicine
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Type of provider
Nurse practitioner
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Type of provider
Fellow
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Type of provider
Resident
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Infiltrated anesthetic
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Buffered with bicarbonate
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Entire laceration repair procedureWeighted 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)
Outcome measures
| Measure |
iPad
n=39 Participants
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).
|
Standard Care
n=38 Participants
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).
|
|---|---|---|
|
Observational Score Behavioral Distress Revised (OSBD-R)
|
2.3 units on a scale
Interval 0.0 to 6.2
|
0.8 units on a scale
Interval 0.1 to 5.5
|
SECONDARY outcome
Timeframe: Survey administered immediately following the laceration repairPopulation: Parent own anxiety survey
Parent rating of own anxiety during the procedure Likert-based scale 1-5 (1 low/better, 5 high/worse)
Outcome measures
| Measure |
iPad
n=39 Participants
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).
|
Standard Care
n=38 Participants
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).
|
|---|---|---|
|
Parent Survey
|
2 score on a scale
Interval 1.0 to 4.0
|
4 score on a scale
Interval 3.8 to 5.0
|
Adverse Events
iPad
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place