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Virtual Reality Goggle Utilization for Venipuncture Distraction

Primary Purpose

Pain, Procedural

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Goggles
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Procedural focused on measuring virtual reality

Eligibility Criteria

5 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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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Sites / Locations

  • Montefiore Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

VR goggle with venipuncture

no VR goggle with venipuncture

Arm Description

Virtual reality goggles SamsungGearVR supplied by KindVR will be placed on patients at least 2 min prior to venipuncture. All patients will also receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture.

Patients will receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture but NO virtual reality goggles.

Outcomes

Primary Outcome Measures

Change in Perceived Pain: scale
change in the perceived pain using Wong-Baker FACES scale pre/post venipuncture. Faces scale converts 6 faces to numbers (0, 2,4,6,8,10) with high "number" indicating worse pain.

Secondary Outcome Measures

Anxiety Scores
Changed in pre/post venipuncture anxiety scores using visual analogue scale where patients mark on a scale their value from 0-100mm.
Heart Rate
Change in HR for patients on cardiac monitor pre/post venipuncture
Level of simulator sickness
Level of simulator sickness with immersive VR distraction during venipuncture using serum sickness survey (4 questions 0-10 asking degree of head hurt, eye hurt, upset stomach and dizziness with 10 being worse outcome)

Full Information

First Posted
July 16, 2020
Last Updated
October 12, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04479735
Brief Title
Virtual Reality Goggle Utilization for Venipuncture Distraction
Official Title
Optimizing the Patient Experience: Virtual Reality Goggle Utilization for Venipuncture Distraction - Can we Decrease Anxiety and Pain During This Common Procedure?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Procedural
Keywords
virtual reality

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized non blinded study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VR goggle with venipuncture
Arm Type
Experimental
Arm Description
Virtual reality goggles SamsungGearVR supplied by KindVR will be placed on patients at least 2 min prior to venipuncture. All patients will also receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture.
Arm Title
no VR goggle with venipuncture
Arm Type
No Intervention
Arm Description
Patients will receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture but NO virtual reality goggles.
Intervention Type
Device
Intervention Name(s)
Virtual Reality Goggles
Intervention Description
Virtual reality goggles will placed at least 2 min prior to venipuncture to deteremine if it mitigates perceived anxiety or perceived pain scores.
Primary Outcome Measure Information:
Title
Change in Perceived Pain: scale
Description
change in the perceived pain using Wong-Baker FACES scale pre/post venipuncture. Faces scale converts 6 faces to numbers (0, 2,4,6,8,10) with high "number" indicating worse pain.
Time Frame
Approximately 1 hour prior to venipuncture and again immediately after venipuncture.
Secondary Outcome Measure Information:
Title
Anxiety Scores
Description
Changed in pre/post venipuncture anxiety scores using visual analogue scale where patients mark on a scale their value from 0-100mm.
Time Frame
Approximately 1 hour prior to venipuncture and again immediately after venipuncture.
Title
Heart Rate
Description
Change in HR for patients on cardiac monitor pre/post venipuncture
Time Frame
Approximately 1 hour prior to venipuncture and again immediate after venipuncture.
Title
Level of simulator sickness
Description
Level of simulator sickness with immersive VR distraction during venipuncture using serum sickness survey (4 questions 0-10 asking degree of head hurt, eye hurt, upset stomach and dizziness with 10 being worse outcome)
Time Frame
Approximately 1 hour prior to venipuncture and again immediately after venipuncture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Courtney A McNamara, MD
Phone
540 514 4389
Email
comcnama@montefiore.org
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine O'Connor, MD
Phone
(917) 776-0512
Email
koconnor@montefiore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney A McNamara, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Reality Goggle Utilization for Venipuncture Distraction

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