Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort

NCT03740607 | Unknown DMC FDA Device

• 1 other identifier: c.2017.114d
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Anxiety; Procedural Pain; Perioperative Care

Keywords

Adult; Peripheral IV; procedural pain; procedural anxiety; virtual reality; peripheral intravenous catheter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Magnitude of pain severity

  This outcome will be measured immediately after peripheral IV placement

• Time spent thinking about pain

  This outcome will be measured immediately after peripheral IV placement

• Degree to which subject felt immersed in virtual reality

  This outcome will be measured immediately after peripheral IV placement

• Nausea

  This outcome will be measured immediately after peripheral IV placement

• Claustrophobia

  This outcome will be measured immediately after peripheral IV placement

Study Arms (2)

Virtual reality during PIV placement

EXPERIMENTAL

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; Procedure: Peripheral intravenous catheter placement

Standard PIV placement

PLACEBO COMPARATOR

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

Interventions

Virtual reality DEVICE

Healthcare virtual reality software implemented during peripheral intravenous catheter placement

Also known as: Samsung Gear Headset, AppliedVR software

Virtual reality during PIV placement

Peripheral intravenous catheter placement PROCEDURE

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

Also known as: IV, PIV

Standard PIV placement; Virtual reality during PIV placement

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

RECRUITING

Related Publications (11)

• 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.

  PMID: 21481162 BACKGROUND

• 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.

  PMID: 21795888 BACKGROUND

• 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.

  PMID: 16640481 BACKGROUND

• 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.

  PMID: 29485536 BACKGROUND

• 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.

  PMID: 25722534 BACKGROUND

• 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.

  PMID: 28356241 BACKGROUND

• 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.

  PMID: 18042882 BACKGROUND

• 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.

  PMID: 18427228 BACKGROUND

• 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.

  PMID: 9357889 BACKGROUND

• 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.

  PMID: 20691523 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Maani, MD

  BAMC Faculty

  STUDY DIRECTOR

Central Study Contacts

Annie L Chow, MD, MPH, MS

CONTACT

6093063329; chowanni@gmail.com

Cheng Yang, MD

CONTACT

chengyang448@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized prospective cohort

Study Record Dates

• First Submitted: November 10, 2018
• First Posted: November 14, 2018
• Study Start: March 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 15, 2022
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)