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Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort

Primary Purpose

Procedural Anxiety, Procedural Pain, Perioperative Care

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual reality
Peripheral intravenous catheter placement
Sponsored by
Brooke Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Procedural Anxiety focused on measuring Adult, Peripheral IV, procedural pain, procedural anxiety, virtual reality, peripheral intravenous catheter

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Brooke Army Medical Center patients age 19-89 undergoing peripheral intravenous catheter placement in preparation for elective surgery will be eligible for participation.

Exclusion Criteria:

Patients will be excluded with head wounds/head bandages preventing the use of a headset, active nausea/vomiting, history of seizure, dementia, psychosis, mania, vertigo, or motion sickness, if the patient is pregnant or incarcerated on the day of surgery, and if the patient is unable to consent self.

Sites / Locations

  • Brooke Army Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Virtual reality during PIV placement

Standard PIV placement

Arm Description

Randomized consented adult subjects will participate in a six-minute healthcare virtual reality software program via Samsung Gear virtual reality headsets while receiving 18 or 20-gauge peripheral intravenous catheter placement in peri-operative suite in preparation for surgery. They will be asked to rate their pain and discomfort afterwards using a graphic rating scale. They will be asked several questions about satisfaction, in order to elicit clinical significance of this intervention. Demographic information will be collected, and baseline vital signs upon arrival to OR will be abstracted retrospectively.

Adult control arm subjects will receive 18 or 20-gauge peripheral intravenous catheter placement according to current standard protocol, without virtual reality distraction .They will be asked to rate pain and discomfort afterwards using a graphic rating scale. Demographic information will be collected, and baseline vital signs upon arrival to OR will be abstracted retrospectively.

Outcomes

Primary Outcome Measures

Discomfort associated with peripheral IV placement
Subject experiences will be measured using a validated graphic rating scale (GRS) which enquires about the extent to which the experience was unpleasant.

Secondary Outcome Measures

Magnitude of pain severity
Subjects will rate their worst pain during the IV placement on a scale of 1-10 out of 10 possible points
Time spent thinking about pain
Subject will describe the amount of time spent thinking about pain during IV placement, as a proportion.
Degree to which subject felt immersed in virtual reality
The subject will answer a question regarding the extent to which they felt they went "inside" the computer-generated world
Nausea
Subject will answer a question regarding extent to which nausea was experienced during IV placement
Claustrophobia
The subject will be asked to answer a question about the extent to which they felt claustrophobic for any reason during IV placement
Clinical significance
the subject will be asked if they would want to have their IV placed this way again
Satisfaction score
The subject will be asked if they were satisfied with IV placement
Physiological parameters
Baseline vital signs- continuous variables
Fun factor
Subject will describe the extent to which they found the experience to be fun, on a scale of 1-10

Full Information

First Posted
November 10, 2018
Last Updated
August 24, 2021
Sponsor
Brooke Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03740607
Brief Title
Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort
Official Title
Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooke Army Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Immersive virtual reality (iVR) has been used successfully to manage pain with distraction. It is a non-invasive treatment modality unassociated with worrisome well-known side effects typically seen when opioids and NSAIDS are used, and has previously been used safely in place of analgesia during dressing changes and burn care. This study investigates whether iVR can be useful as a stand-alone option to manage the pain associated with placement of peripheral intravenous (PIV) catheters in adults.
Detailed Description
This is a prospective study of the effect of immersive virtual reality on the perception of pain during peripheral IV (PIV) placement. Adult patients who require PIV placement for elective surgery will be consented for intervention while in the peri-operative suites (PS). The VR intervention will consist of a headset and immersive VR software that allows the patient to engage in a virtual world during PIV placement. Subjects will be queried immediately after PIV placement using the validated graphic rating scale regarding the sensory, cognitive, and affective aspects of discomfort they experienced with PIV placement (Appendix A). They will also be asked two validated questions concerning patient satisfaction (Dexter et al 1997). A control group of patients will undergo a similar assessment with slightly different wording after receiving PIV placement without iVR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Anxiety, Procedural Pain, Perioperative Care
Keywords
Adult, Peripheral IV, procedural pain, procedural anxiety, virtual reality, peripheral intravenous catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
randomized prospective cohort
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality during PIV placement
Arm Type
Experimental
Arm Description
Randomized consented adult subjects will participate in a six-minute healthcare virtual reality software program via Samsung Gear virtual reality headsets while receiving 18 or 20-gauge peripheral intravenous catheter placement in peri-operative suite in preparation for surgery. They will be asked to rate their pain and discomfort afterwards using a graphic rating scale. They will be asked several questions about satisfaction, in order to elicit clinical significance of this intervention. Demographic information will be collected, and baseline vital signs upon arrival to OR will be abstracted retrospectively.
Arm Title
Standard PIV placement
Arm Type
Placebo Comparator
Arm Description
Adult control arm subjects will receive 18 or 20-gauge peripheral intravenous catheter placement according to current standard protocol, without virtual reality distraction .They will be asked to rate pain and discomfort afterwards using a graphic rating scale. Demographic information will be collected, and baseline vital signs upon arrival to OR will be abstracted retrospectively.
Intervention Type
Device
Intervention Name(s)
Virtual reality
Other Intervention Name(s)
Samsung Gear Headset, AppliedVR software
Intervention Description
Healthcare virtual reality software implemented during peripheral intravenous catheter placement
Intervention Type
Procedure
Intervention Name(s)
Peripheral intravenous catheter placement
Other Intervention Name(s)
IV, PIV
Intervention Description
Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.
Primary Outcome Measure Information:
Title
Discomfort associated with peripheral IV placement
Description
Subject experiences will be measured using a validated graphic rating scale (GRS) which enquires about the extent to which the experience was unpleasant.
Time Frame
This outcome will be measured immediately after peripheral IV placement
Secondary Outcome Measure Information:
Title
Magnitude of pain severity
Description
Subjects will rate their worst pain during the IV placement on a scale of 1-10 out of 10 possible points
Time Frame
This outcome will be measured immediately after peripheral IV placement
Title
Time spent thinking about pain
Description
Subject will describe the amount of time spent thinking about pain during IV placement, as a proportion.
Time Frame
This outcome will be measured immediately after peripheral IV placement
Title
Degree to which subject felt immersed in virtual reality
Description
The subject will answer a question regarding the extent to which they felt they went "inside" the computer-generated world
Time Frame
This outcome will be measured immediately after peripheral IV placement
Title
Nausea
Description
Subject will answer a question regarding extent to which nausea was experienced during IV placement
Time Frame
This outcome will be measured immediately after peripheral IV placement
Title
Claustrophobia
Description
The subject will be asked to answer a question about the extent to which they felt claustrophobic for any reason during IV placement
Time Frame
This outcome will be measured immediately after peripheral IV placement
Title
Clinical significance
Description
the subject will be asked if they would want to have their IV placed this way again
Time Frame
This outcome will be measured immediately after peripheral IV placement
Title
Satisfaction score
Description
The subject will be asked if they were satisfied with IV placement
Time Frame
This outcome will be measured immediately after peripheral IV placement
Title
Physiological parameters
Description
Baseline vital signs- continuous variables
Time Frame
Initial vital signs at start of anesthesia care will be abstracted retrospectively. This reading will likely occur within an hour of the initial intervention, as start times for anesthesia cases are within an hour of initiation of peri-operative care
Title
Fun factor
Description
Subject will describe the extent to which they found the experience to be fun, on a scale of 1-10
Time Frame
This outcome will be measured immediately after peripheral IV placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Brooke Army Medical Center patients age 19-89 undergoing peripheral intravenous catheter placement in preparation for elective surgery will be eligible for participation. Exclusion Criteria: Patients will be excluded with head wounds/head bandages preventing the use of a headset, active nausea/vomiting, history of seizure, dementia, psychosis, mania, vertigo, or motion sickness, if the patient is pregnant or incarcerated on the day of surgery, and if the patient is unable to consent self.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annie L Chow, MD, MPH, MS
Phone
6093063329
Email
chowanni@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng Yang, MD
Email
chengyang448@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Maani, MD
Organizational Affiliation
BAMC Faculty
Official's Role
Study Director
Facility Information:
Facility Name
Brooke Army Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie Chow, MD
Phone
210-228-6877
Email
annie.l.chow.mil@mail.mil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21481162
Citation
Maani CV, Hoffman HG, Fowler M, Maiers AJ, Gaylord KM, Desocio PA. Combining ketamine and virtual reality pain control during severe burn wound care: one military and one civilian patient. Pain Med. 2011 Apr;12(4):673-8. doi: 10.1111/j.1526-4637.2011.01091.x. Epub 2011 Apr 11.
Results Reference
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PubMed Identifier
21795888
Citation
Maani CV, Hoffman HG, Morrow M, Maiers A, Gaylord K, McGhee LL, DeSocio PA. Virtual reality pain control during burn wound debridement of combat-related burn injuries using robot-like arm mounted VR goggles. J Trauma. 2011 Jul;71(1 Suppl):S125-30. doi: 10.1097/TA.0b013e31822192e2.
Results Reference
background
PubMed Identifier
16640481
Citation
Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.
Results Reference
background
PubMed Identifier
29485536
Citation
Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599.
Results Reference
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PubMed Identifier
25722534
Citation
Rosen LD, Whaling K, Carrier LM, Cheever NA, Rokkum J. The Media and Technology Usage and Attitudes Scale: An empirical investigation. Comput Human Behav. 2013 Nov 1;29(6):2501-2511. doi: 10.1016/j.chb.2013.06.006.
Results Reference
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PubMed Identifier
28356241
Citation
Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.
Results Reference
background
PubMed Identifier
18042882
Citation
Hoffman HG, Richards TL, Van Oostrom T, Coda BA, Jensen MP, Blough DK, Sharar SR. The analgesic effects of opioids and immersive virtual reality distraction: evidence from subjective and functional brain imaging assessments. Anesth Analg. 2007 Dec;105(6):1776-83, table of contents. doi: 10.1213/01.ane.0000270205.45146.db.
Results Reference
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PubMed Identifier
18427228
Citation
Hoffman HG, Patterson DR, Seibel E, Soltani M, Jewett-Leahy L, Sharar SR. Virtual reality pain control during burn wound debridement in the hydrotank. Clin J Pain. 2008 May;24(4):299-304. doi: 10.1097/AJP.0b013e318164d2cc.
Results Reference
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PubMed Identifier
9357889
Citation
Dexter F, Aker J, Wright WA. Development of a measure of patient satisfaction with monitored anesthesia care: the Iowa Satisfaction with Anesthesia Scale. Anesthesiology. 1997 Oct;87(4):865-73. doi: 10.1097/00000542-199710000-00021.
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Citation
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Results Reference
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Citation
Kenney MP, Milling LS. The effectiveness of virtual reality distraction for reducing pain: a meta-analysis. Psychology of Consciousness: Theory, Research, and Practice 3(3): 199-210, 2016.
Results Reference
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Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort

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