AnxietyNCT02217436
iPad as a Distraction Tool During Facial Laceration Repair
A study testing iPad in people with Anxiety and Laceration Repair, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Anxiety, Laceration Repair, Children
- What is being tested?
- iPad
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Parents of enrolled patients.
- Providers of enrolled patients: Residents, fellows, attendings, and nurse practitioners serving as the primary provider performing the laceration repair.
Who cannot join
- 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.
- Parents and/or providers of children not eligible or enrolled in the study.
- Providers: Medical students performing the laceration repair.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rady Children's Hospital San Diego
San Diego, California, 92123
About this study
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.
- Conditions
- Anxiety, Laceration Repair, Children
- Being tested
- iPad, Standard Care
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPadDevice
iPad with age-appropriate applications, videos, and music
Standard CareOther
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).
| Study group | Role | What they receive |
|---|---|---|
| iPad | Experimental | iPad with age-appropriate applications, videos, and music Receives: Device: iPad; Other: Standard Care |
| Standard Care | Active comparator | 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). Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Entire laceration repair procedure
Secondary outcomes (1)
Parent Survey
Parent rating of own anxiety during the procedure Likert-based scale 1-5 (1 low/better, 5 high/worse)
Measured: Survey administered immediately following the laceration repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Williams, University of California, San Diego
- Investigators
- Bema Bonsu, MD, Principal investigator, University of California, San Diego and Rady Children's Hospital San DiegoAmy Williams, MD, Principal investigator, University of California, San Diego and Rady Children's Hospital San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217436
- Sponsor's protocol ID
- iPadWilliams
- Status last verified
- Jul 2019
- First submitted
- 8 Aug 2014
- Last updated
- 23 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 17596217Luhmann 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.
PubMed 11145766McQueen 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.
PubMed 22766593Sinha 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.
PubMed 16585311Jay 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.
PubMed 6520283Bryl 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.
PubMed 30422942
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iPad as a Distraction Tool During Facial Laceration Repair
- ClinicalTrials.gov ID
- NCT02217436
- Acronym / sponsor ID
- iPadWilliams
- Conditions
- Anxiety, Laceration Repair, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Posted 23 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iPad | Experimental | Device: iPad, Other: Standard CareiPad with age-appropriate applications, videos, and music |
| Standard Care | Active comparator | Other: Standard CareAll 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). |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
- Parents of enrolled patients.
- Providers of enrolled patients: Residents, fellows, attendings, and nurse practitioners serving as the primary provider performing the laceration repair.
Key exclusion criteria (3 listed)
- 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.
- Parents and/or providers of children not eligible or enrolled in the study.
- Providers: Medical students performing the laceration repair.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPadiPad with age-appropriate applications, videos, and music | Device | iPad |
| Standard CareAll 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 |
Primary outcome
Observational Score Behavioral Distress Revised (OSBD-R)
Time frame: 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)
1 secondary outcome
Parent Survey
Time frame: Survey administered immediately following the laceration repair
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17596217Crellin 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.
- Background: PubMed 11145766Luhmann 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.
- Background: PubMed 22766593McQueen 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.
- Background: PubMed 16585311Sinha 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.
- Background: PubMed 6520283Jay 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.
- Derived from this study: PubMed 30422942Bryl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bema Bonsu, MD principal investigator
University of California, San Diego and Rady Children's Hospital San Diego
Amy Williams, MD principal investigator
University of California, San Diego and Rady Children's Hospital San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPad in people with Anxiety and Laceration Repair, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observational Score Behavioral Distress Revised (OSBD-R) (time frame: Entire laceration repair procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02217436, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.