Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort

NCT ID: NCT03740607

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2022-09-15

Brief Summary

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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

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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.

Conditions

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Procedural Anxiety Procedural Pain Perioperative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

randomized prospective cohort
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Virtual reality

Intervention Type DEVICE

Healthcare virtual reality software implemented during peripheral intravenous catheter placement

Peripheral intravenous catheter placement

Intervention Type PROCEDURE

Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.

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.

Group Type PLACEBO_COMPARATOR

Peripheral intravenous catheter placement

Intervention Type PROCEDURE

Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.

Interventions

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Virtual reality

Healthcare virtual reality software implemented during peripheral intravenous catheter placement

Intervention Type DEVICE

Peripheral intravenous catheter placement

Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.

Intervention Type PROCEDURE

Other Intervention Names

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Samsung Gear Headset, AppliedVR software IV PIV

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brooke Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Annie Chow

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Maani, MD

Role: STUDY_DIRECTOR

BAMC Faculty

Locations

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Brooke Army Medical Center

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Annie L Chow, MD, MPH, MS

Role: CONTACT

6093063329

Cheng Yang, MD

Role: CONTACT

Facility Contacts

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Annie Chow, MD

Role: primary

210-228-6877

References

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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.

Reference Type BACKGROUND
PMID: 21481162 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21795888 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16640481 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29485536 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25722534 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28356241 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18042882 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18427228 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9357889 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20691523 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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c.2017.114d

Identifier Type: -

Identifier Source: org_study_id

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