Brief Summary
This is a randomized non-blinded trial evaluating the effect of virtual reality goggles on perceived pain and anxiety scores during venipuncture on hospitalized children ages 5-21. We will randomized patients to either standard of care (including Lidocaine 2.5%/Prilocaine 2.5% cream as a topical anesthetic 60-240 minutes prior to venipuncture) or standard of care plus virtual reality goggles.
Brief Title
Virtual Reality Goggle Utilization for Venipuncture Distraction
Detailed Description
Study personnel will identify patients on CHAM 6 and CHAM 8 scheduled for lab draw prior to child life rounds and subsequently ask the health care providers if there are any patients that are not developmentally or physically appropriate to use the VR equipment. They will then screen and consent the patients approximately 1 hour prior to the Child Life rounds (see appendix A \& B). Patients aged 12-17 years old who are able to read the form will be asked to fill out an assent form (see appendix C) and patients aged 5-12 years old and those unable to read the form will be read the assent form to ensure verbal assent. Those patients who consent to the study will be randomized to a VR arm and non VR arm using computer generated randomization. Lidocaine 2.5%/Prilocaine 2.5% cream will be placed on all patients that have consented to the study by the patient's nurse if they don't already have it applied. After consent and assurance of topical anesthetic application, a brief demographic questionnaire (see appendix D) will also be completed. For efficiency and feasibility, two study personnel will screen and consent families, assist with VR set up and removal, and conduct post procedure assessment.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
540 514 4389
Central Contact Email
comcnama@montefiore.org
Central Contact Role
Contact
Central Contact Phone
(917) 776-0512
Central Contact Email
koconnor@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
Pain, Procedural
Eligibility Criteria
Inclusion Criteria:
patients aged 5-21 years old admitted to the 6th floor of the inpatient unit who are scheduled for a venipuncture during morning phlebotomy rounds
Exclusion Criteria:
Patients developmentally or physically not appropriate to use the VR equipment as determined by their parent, guardian or healthcare provider, if there is discomfort related to wearing the goggles (for example: recent neurosurgery, migraines, hardware on head), patient have photosensitive seizures or infectious concern such as scabies, lice, COVID-19 that can't reliably be disinfected.
Patient (\>18) or Parent or guardian (for patient \< 18) that does not speak English, Spanish or Arabic will be excluded.
If patient refuses Lidocaine 2.5%/Prilocaine 2.5% cream use they will also be excluded from the study.
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patients aged 5-21 years old admitted to the 6th floor of the inpatient unit who are scheduled for a venipuncture during morning phlebotomy rounds
Exclusion Criteria:
Patients developmentally or physically not appropriate to use the VR equipment as determined by their parent, guardian or healthcare provider, if there is discomfort related to wearing the goggles (for example: recent neurosurgery, migraines, hardware on head), patient have photosensitive seizures or infectious concern such as scabies, lice, COVID-19 that can't reliably be disinfected.
Patient (\>18) or Parent or guardian (for patient \< 18) that does not speak English, Spanish or Arabic will be excluded.
If patient refuses Lidocaine 2.5%/Prilocaine 2.5% cream use they will also be excluded from the study.
-
Inclusion Criteria
Inclusion Criteria:
patients aged 5-21 years old admitted to the 6th floor of the inpatient unit who are scheduled for a venipuncture during morning phlebotomy rounds
patients aged 5-21 years old admitted to the 6th floor of the inpatient unit who are scheduled for a venipuncture during morning phlebotomy rounds
Gender
All
Gender Based
false
Keywords
virtual reality
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
21 Years
Minimum Age
5 Years
NCT Id
NCT04479735
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2020-11200
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Optimizing the Patient Experience: Virtual Reality Goggle Utilization for Venipuncture Distraction - Can we Decrease Anxiety and Pain During This Common Procedure?
Primary Outcomes
Outcome Description
Change in perceived pain from pre-venipuncture to post-venipuncture (during the blood draw) will be assessed using the Wong-Baker FACES Pain Rating scale. Children, or parents on behalf of children, will be asked to communicate the severity of the pain the child is experiencing using the FACES scale which contains a series of 6 different facial expressions correlated to numbers (i.e., 0, 2, 4, 6, 8, 10) ranging from a happy face at "0" indicating "no hurt" to a crying face at "10" indicating "hurts worst." Higher scale scores signify worse pain severity. Change in group mean FACES scale scores will be summarized by study arm and subsequently analyzed using Wilcoxon signed rank test for paired data.
Outcome Measure
Change in Perceived Pain Scale
Outcome Time Frame
Approximately 1 hour prior to venipuncture and again immediately after venipuncture
Secondary Outcomes
Outcome Description
Change in anxiety from pre-venipuncture to post-venipuncture (during the blood draw) will be assessed using the Visual Analog Scale (VAS). Children, or parents on behalf of children, will be asked to estimate the level of anxiety the child is having by marking their estimate on a visual 0-to-100 millimeter (mm) line ranging from "0" (=Not at all Anxious) to "100" (=Extremely Anxious). The line increases by increments of "1" from left to right. A score of ≥ 30mm is considered anxious. Change in anxiety scores will be summarized by study arm using basic descriptive statistics and subsequently analyzed using Wilcoxon signed rank test for paired data.
Outcome Time Frame
Approximately 1 hour prior to venipuncture and again immediately after venipuncture
Outcome Measure
Change in Anxiety Scores
Outcome Description
Change in HR from pre-venipuncture to post-venipuncture will be evaluated for those patients on a cardiac monitor. Increased heart rate can be associated with increases in pain and anxiety. Group mean changes in heart will be summarized by study arm and subsequently analyzed using Wilcoxon signed rank test for paired data.
Outcome Time Frame
Approximately 1 hour prior to venipuncture and again immediate after venipuncture
Outcome Measure
Change in Heart Rate
Outcome Description
Change in Level of simulator sickness from pre-venipuncture (pre-placement of Virtual Reality goggles) to post-venipuncture (removal of VR goggles) will be assessed using a Simulator Sickness Questionnaire. The survey consists for 4 questions related to the possible side effects of using the VR goggles. Children, or parents on behalf of children, will be asked to respond to the following 4 questions on a scale ranging from 1-10: Does your head hurt? Do your eyes hurt? Do you have an upset stomach? Do you feel dizzy? Total scores will be summed for an overall possible scoring range of 4-40 with higher scores indicating worse sickness symptoms. Change in simulator sickness scores will be summarized by study arm.
Outcome Time Frame
Approximately 1 hour prior to venipuncture and again immediately after venipuncture
Outcome Measure
Change in Level of simulator sickness
Outcome Description
Level of pre venipuncture anxiety scores in participants with prior hospitalizations or prior medical problems will be evaluated. Anxiety scores will be collected using the VAS tool. Children, or parents on behalf of children, will be asked to estimate the level of anxiety the child is having by marking their estimate on a visual 0-to-100mm line ranging from "0" (=Not at all Anxious) to "100" (=Extremely Anxious). The line increases by increments of "1" from left to right. A score of ≥ 30mm is considered anxious. Prior hospitalization data and prior medical problem information will be extracted via chart review. Anxiety scores will be summarized by study arm using basic descriptive statistics. An independent t test will be used to asses whether anxiety scores are normally distributed or Mann U test if not normally distributed.
Outcome Time Frame
Baseline
Outcome Measure
Pre-venipuncture anxiety scores in participants with prior hospitalizations or prior medical problems.
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
21
Minimum Age Number (converted to Years and rounded down)
5
Investigators
Investigator Type
Principal Investigator
Investigator Name
Courtney Mcnamara
Investigator Email
comcnama@montefiore.org
Investigator Phone
540-514-4389