Can Virtual Reality Reduce Pain and Anxiety During Blood Draw

NCT04449341 | Completed Results FDA Device

• 1 other identifier: 921118
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Adult patients aged 18-50 undergoing blood draw for routine lab evaluation will be randomized to a control group or experimental group to assess if the use of virtual reality reduces procedural pain (primary outcome) and procedural anxiety (secondary outcome) during venipuncture.

Conditions

Procedural Anxiety; Procedural Pain

Keywords

virtual reality; venipuncture; blood draw; Oculus Go

Outcome Measures

Primary Outcomes (1)

• Procedural Pain

  Determine if use of Oculus Go headset reduces procedural pain perception utilizing the visual analog scale, which measures pain on a linear scale from 0 to 100 millimeters, with 0 being no pain and 100 being maximum pain

  2 months

Secondary Outcomes (1)

• Procedural Anxiety

  2 months

Study Arms (2)

Standard care venipuncture with additional of virtual reality

EXPERIMENTAL

Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset

Device: Oculus Go headset with Ocean Rift application

Standard care venipuncture without addition of virtual reality

NO INTERVENTION

Patients undergoing blood draw while wearing Oculus Go headset that is turned off

Interventions

Oculus Go headset with Ocean Rift application DEVICE

Information already included in arm description

Standard care venipuncture with additional of virtual reality

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-50
• Currently scheduled to undergo venipuncture

You may not qualify if:

• Less than 18 years old or greater than 50 years old
• History of motion sickness (nausea or vertigo)
• Pregnant women
• Reported history of blood borne disease (no request will be made for which disease participant has)
• Use of pain medication(s) on day of study
• Current use of medical devices, including hearing aids, pacemakers, implanted cardiac defibrillators
• Currently experiencing headache/migraine

Sponsors & Collaborators

• C.R.Darnall Army Medical Center: lead

Study Sites (1)

Carl R Darnall Army Medical Center

Fort Hood, Texas, 76544, United States

Location

Related Publications (15)

• Atzori B, Hoffman HG, Vagnoli L, Patterson DR, Alhalabi W, Messeri A, Lauro Grotto R. Virtual Reality Analgesia During Venipuncture in Pediatric Patients With Onco-Hematological Diseases. Front Psychol. 2018 Dec 20;9:2508. doi: 10.3389/fpsyg.2018.02508. eCollection 2018.

  PMID: 30618938 BACKGROUND

• Cassidy KL, Reid GJ, McGrath PJ, Finley GA, Smith DJ, Morley C, Szudek EA, Morton B. Watch needle, watch TV: Audiovisual distraction in preschool immunization. Pain Med. 2002 Jun;3(2):108-18. doi: 10.1046/j.1526-4637.2002.02027.x.

  PMID: 15102157 BACKGROUND

• Lee JS, Hobden E, Stiell IG, Wells GA. Clinically important change in the visual analog scale after adequate pain control. Acad Emerg Med. 2003 Oct;10(10):1128-30. doi: 10.1111/j.1553-2712.2003.tb00586.x.

  PMID: 14525749 BACKGROUND

• Dahlquist LM, Weiss KE, Law EF, Sil S, Herbert LJ, Horn SB, Wohlheiter K, Ackerman CS. Effects of videogame distraction and a virtual reality type head-mounted display helmet on cold pressor pain in young elementary school-aged children. J Pediatr Psychol. 2010 Jul;35(6):617-25. doi: 10.1093/jpepsy/jsp082. Epub 2009 Sep 28.

  PMID: 19786489 BACKGROUND

• Garrett B, Taverner T, Masinde W, Gromala D, Shaw C, Negraeff M. A rapid evidence assessment of immersive virtual reality as an adjunct therapy in acute pain management in clinical practice. Clin J Pain. 2014 Dec;30(12):1089-98. doi: 10.1097/AJP.0000000000000064.

  PMID: 24535053 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

• Gold JI, Belmont KA, Thomas DA. The neurobiology of virtual reality pain attenuation. Cyberpsychol Behav. 2007 Aug;10(4):536-44. doi: 10.1089/cpb.2007.9993.

  PMID: 17711362 BACKGROUND

• Hoffman HG, Patterson DR, Carrougher GJ, Sharar SR. Effectiveness of virtual reality-based pain control with multiple treatments. Clin J Pain. 2001 Sep;17(3):229-35. doi: 10.1097/00002508-200109000-00007.

  PMID: 11587113 BACKGROUND

• Hoffman HG, Sharar SR, Coda B, Everett JJ, Ciol M, Richards T, Patterson DR. Manipulating presence influences the magnitude of virtual reality analgesia. Pain. 2004 Sep;111(1-2):162-8. doi: 10.1016/j.pain.2004.06.013.

  PMID: 15327820 BACKGROUND

• Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.

  PMID: 21779307 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

• Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.

  PMID: 11719741 BACKGROUND

• Moore B, Stocks C, Owens P. Trends in Emergency Department Visits, 2006-2014. Healthcare Cost and Utilization Project (HCUP) Statistical Brief #227. 2017

  BACKGROUND

• Wiederhold BK, Gao K, Kong L, Wiederhold MD. Mobile devices as adjunctive pain management tools. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):385-9. doi: 10.1089/cyber.2014.0202.

  PMID: 24892202 BACKGROUND

• Ozalp Gerceker G, Ayar D, Ozdemir EZ, Bektas M. Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12 years old: A randomised controlled study. J Clin Nurs. 2020 Apr;29(7-8):1151-1161. doi: 10.1111/jocn.15173. Epub 2020 Jan 22.

  PMID: 31889358 BACKGROUND

Related Links

• 2018 Demographics Report: Profile of the Military Community

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Matthew Perdue
• Organization: Carl R Darnall Army Medical Center

matthewperdue94@gmail.com

(254) 553-4653

Study Officials

• Matthew J Perdue, PA

  C.R.Darnall Army Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow, US Army-Baylor DSc Emergency Medicine PA Studies, Principal Investigator

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 26, 2020
• Study Start: June 10, 2020
• Primary Completion: July 9, 2020
• Study Completion: July 9, 2020
• Last Updated: July 13, 2021
• Results First Posted: June 11, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)