Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort

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.

Study Overview

• Status: Recruiting
• Conditions: Perioperative Care; Procedural Pain; Procedural Anxiety
• Intervention / Treatment: Device: Virtual reality; Procedure: Peripheral intravenous catheter placement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annie L Chow, MD, MPH, MS; Phone Number: 6093063329; Email: chowanni@gmail.com
• Study Contact Backup: Name: Cheng Yang, MD; Email: chengyang448@gmail.com

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78234
      • Recruiting
      • Brooke Army Medical Center
      • Contact: Annie Chow, MD; Phone Number: 210-228-6877; Email: annie.l.chow.mil@mail.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual reality during PIV placement; 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.	Device: Virtual reality; Healthcare virtual reality software implemented during peripheral intravenous catheter placement; Other Names: Samsung Gear Headset, AppliedVR software; Procedure: Peripheral intravenous catheter placement; Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.; Other Names: IV; PIV
Placebo Comparator: Standard PIV placement; 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.	Procedure: Peripheral intravenous catheter placement; Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.; Other Names: IV; PIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This outcome will be measured immediately after peripheral IV placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	This outcome will be measured immediately after peripheral IV placement
Time spent thinking about pain	Subject will describe the amount of time spent thinking about pain during IV placement, as a proportion.	This outcome will be measured immediately after peripheral IV placement
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	This outcome will be measured immediately after peripheral IV placement
Nausea	Subject will answer a question regarding extent to which nausea was experienced during IV placement	This outcome will be measured immediately after peripheral 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	This outcome will be measured immediately after peripheral IV placement
Clinical significance	the subject will be asked if they would want to have their IV placed this way again	This outcome will be measured immediately after peripheral IV placement
Satisfaction score	The subject will be asked if they were satisfied with IV placement	This outcome will be measured immediately after peripheral IV placement
Physiological parameters	Baseline vital signs- continuous variables	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
Fun factor	Subject will describe the extent to which they found the experience to be fun, on a scale of 1-10	This outcome will be measured immediately after peripheral IV placement

Collaborators and Investigators

• Sponsor: Brooke Army Medical Center
• Investigators: Study Director: Christopher Maani, MD, BAMC Faculty

Publications and helpful links

General Publications

• Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 15, 2022

Study Registration Dates

• First Submitted: November 10, 2018
• First Submitted That Met QC Criteria: November 10, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Adult; virtual reality; Peripheral IV; procedural pain; procedural anxiety; peripheral intravenous catheter
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Procedural
• Other Study ID Numbers: c.2017.114d

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes