An interventional study of Virtual Reality App in Procedural Anxiety and Laceration of Skin, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 5 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-03.
Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Treatment
Among 60 studies in Lacerations with a site in United States — 12 open to participants now, 14 under way, 1 of them phase 3. Lacerations · United States.
Among the 60 studies in Lacerations with a site in United States, this one is the 32nd largest by enrollment of the 52 interventional ones, is one of 5 that started in 2018, is one of 33 with no phase, and was the 31st registered.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's enrollment of 40 is below the median of 65 across 128 interventional studies indexed under Lacerations.
Browse Lacerations studies →12 of the 60 studies in Lacerations with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 27 Lacerations studies recruiting now, 15 (56%) set no upper age limit and 10 (37%) stop at 75 or younger; 6 take children under 18; 9 take healthy volunteers.
This study: 5 Years to 13 Years · all sexes · healthy volunteers too.
The full table on the hub →60 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 5 started in 2018.
Median enrollment 52 across the 52 interventional studies, 50 across the 7 observational. Of the 36 that completed or were terminated, 18 (50%) have results posted.
8 of 60 have an industry lead sponsor. The 10 most frequent:
Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
Montefiore Medical Center has 2 studies filed under Lacerations — fewer than ten, so there is no comparison to draw.
6 of the studies in Lacerations with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06910241Phase 3Florida Atlantic UniversityLidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs | 2027-06-30 |
| NCT07606625University of California, BerkeleyOcular Surface Health and Tear Film Stability With a Nasal Spray Dry Eye Treatment | 2026-12-31 |
| NCT07068880Brett LewellynClinical Analysis of a Novel Flexor Tendon Repair Technique | 2027-01 |
| NCT07632183Edward Via Virginia College of Osteopathic MedicineWill a Hands on Technique Applied to the Face Increase the Tear Production in Participants | 2027-06 |
| NCT07688967Arthroresearch LLCMeasuring Knee Laxity and Pivot Shift in ACL-Deficient Patients | 2027-07 |
Among the 60 studies in Lacerations with a site in United States, from their registry updates:
The investigators propose a pilot study to examine the feasibility of utilizing immersive virtual reality to reduce procedural anxiety in children undergoing non-facial laceration repair in the Pediatric Emergency Department.
The investigators hypothesize that virtual reality will be well-received by patients and their caregivers, and that the anxiety provoked by laceration repair will be mitigated by the immersive virtual reality experience.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Virtual reality app produced by KindVR played via a stereoscopic head mounted display (Samsung GearVR) and headphones that the patient will wear over their eyes and ears.
Other: Virtual Reality App
Virtual reality app produced by KindVR played via a stereoscopic head mounted display (Samsung GearVR) and headphones that the patient will wear over their eyes and ears.
The percentage of children whose anxiety score did NOT increase by ≥ 20mm on a visual analog anxiety scale
Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).
Time frame: from the time of enrollment to the placement of the first stitch, which is typically ranges from 15 to 90 minutes
Change in anxiety score
Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).
Time frame: from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes
Change in anxiety score
Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).
Time frame: from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes
Change in anxiety score
Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).
Time frame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Patient satisfaction with the use of VR during the procedure as assessed by a patient questionnaire
To assess the receptiveness of patients to this technology as well as the efficacy of the VR experience, participants will be asked to complete a brief questionnaire at the end of the procedure assessing their experience while using VR during the laceration repair. These surveys address the patient's comfort and satisfaction with the technology. We have created separate patient surveys for children ages 5-7 and children ages 8-13 - these surveys have the same questions, but the answer choices are simplified from Likert Rating Scales (scale of 1 - 5) for the older children to a simple "Yes, No, I don't know" choice for the younger children. There is also a free text response question for which patients can provide additional comments or suggestions regarding their use of VR during laceration repair.
Time frame: Patients will fill out the questionnaire at the time their sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
Parent/guardian satisfaction with the use of VR during the procedure as assessed by a parent/guardian questionnaire
To assess the receptiveness of patients to this technology as well as the efficacy of the VR experience, parents/guardians will be asked to complete a brief survey at the end of the procedure assessing their comfort and satisfaction with their child's use of VR during the laceration repair. The survey contains both rating questions with Likert Rating Scales (scale of 1 - 5), yes/no questions, and questions with free text responses.
Time frame: Parent/guardian will fill out the questionnaire at the time their child's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
Provider satisfaction with the use of VR during the procedure as measured by a provider questionnaire
The ED provider who performed the laceration repair will complete a survey at the end of the procedure assessing their satisfaction with using VR during laceration repair. The survey contains yes/no questions, multiple choice questions, and questions with free text responses.
Time frame: Providers will fill out the questionnaire at the time their patient's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
Need for adjunctive anxiolysis methods, sedation, or restraints during the procedure as reported on a provider questionnaire
The ED provider who performed the laceration repair will complete a questionnaire at the end of the procedure which will detail which, if any, adjunctive measures were needed during the procedure.
Time frame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Headache due to VR use as reported on a qualitative simulator sickness questionnaire
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
Time frame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Eye pain due to VR use as reported on a qualitative simulator sickness questionnaire
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
Time frame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Nausea due to VR use as reported on a qualitative simulator sickness questionnaire
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
Time frame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Dizziness due to VR use as reported on a qualitative simulator sickness questionnaire
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
Time frame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Barriers to the use of VR identified during this study as reported on a provider questionnaire
The ED provider who performed the laceration repair will complete a questionnaire at the end of the procedure which will detail which, if any, barriers to the use of VR that they encountered during the procedure
Time frame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2018 to primary completion in Nov 2019, 19 months.
Of 46 non-industry interventional studies with no phase under Lacerations, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 72. This study's 19 months is close to that.
Counting every sponsor, half of 50 studies reached it within 19 months; a quarter within 12 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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