AzTrials
AzTrials

Procedural AnxietyNCT04449341

Can Virtual Reality Reduce Pain and Anxiety During Blood Draw

A study testing Oculus Go headset with Ocean Rift application in people with Procedural Anxiety and Procedural Pain, run by C.R.Darnall Army Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Procedural Anxiety, Procedural Pain
What is being tested?
Oculus Go headset with Ocean Rift application
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteUnited States
Study dates
10 Jun 2020to 9 Jul 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Carl R Darnall Army Medical Center

    Fort Hood, Texas, 76544

Other trials in United States

About this study

Official title: Can Virtual Reality Reduce Patient's Pain, Improve Patient's Experience, and Reduce Procedure Related Anxiety With Venipuncture? A Randomized Control Trial

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.

Read the detailed description

A prospective randomized controlled trial comparing standard practice for conducting venipuncture to standard practice with the addition of Virtual Reality using the Oculus Go Head Mounted Display (HMD). The study will be performed on volunteers who are reporting to the phlebotomy lab to have venipuncture for blood draws that were previously ordered by their health care providers. Participants who were not already scheduled to undergo routine venipuncture will not be included.

When approaching the ticket stand to draw a waiting number for the lab, prospective participants will be asked by an assistant investigator located near the kiosk if they are interested in participating in the study. If the participants express interest, they will be directed to the screening station. The screening station will be set up in a private room near the lab waiting area, and participants will be screened for eligibility and educated on the benefits and risks of the study. They will also provide informed consent if they decide to participate.

All participants will be asked to fill out a self-reported data questionnaire in addition to the informed consent document to assess for inclusion and exclusion criteria discussed later in this protocol. This questionnaire will assess the participant's expected level of anxiety prior to the procedure and expected level of pain associated with the procedure by utilizing a visual analog scale (VAS). The VAS will be on a 100 millimeter line.

Once approved for participation in the study all participants will undergo a brief instructional class on how to operate the HMD and will be allowed sufficient time to become comfortable with its use. The investigators expect approximately 5-10 minutes to be required for this portion of the study. Once familiar with the use of the virtual reality headset, participants will be asked to randomly draw an envelope from a container. This envelope will contain a block and sequence number. The block and sequence number will be the subject identification and will correspond to a predetermined number set on a separate document that will determine if the participant will use the HMD during venipuncture or not. The screener will not have immediate access to the list showing which group the participant will be assigned to. One member of the study team will be present in the lab room to ensure the participant uses the virtual reality headset (or not) according to what is randomly drawn. This member of the research team will have the list showing whether or not the participant is assigned to the control arm or the experimental arm. The participants will then proceed to the specimen room to undergo venipuncture.

Venipuncture for both groups will be occur in the non-dominant arm. The reasoning for this is that the Oculus Go requires one free hand to use a controller. This will ensure that the individuals participating are able to effectively use the device. Those unable to undergo venipuncture in the nondominant arm will undergo venipuncture in the dominant arm instead and will use the Oculus Go dominant arm will undergo venipuncture in the dominant arm instead and will use the Oculus Go controller with their non-dominant hand.

Those utilizing the Oculus Go HMD will be interacting with the virtual reality game Ocean Rift. They will utilize a single controller to explore an underwater safari park. Ocean Rift has multiple environments to choose from, including coral reefs, ship wrecks, lagoons, the arctic, and prehistoric seas. Participants may interact with and and learn about different creatures to include dolphins, turtles, orcas, ray, whales, sea lions, manatees, and dinosaurs. During the game users may travel where they please and interact with what they choose. The virtual reality device is equipped with head-tracking software that allows the user to choose direction by looking around. The entire interior and exterior of the headset will be cleaned with alcohol-based wipes after each use. Alcohol will be used since it is generally well-tolerated on human skin, and since it evaporates quickly. The headset will be dried in the open air for a minimum of two minutes between each subject's use.

Those not using the virtual reality will still wear a headset that will simply be turned off. This is to ensure that any significant change noted with the virtual reality is due to the use of virtual reality itself, and not simply due to "blindfolding" the patient during the procedure.

As some patients experiencing anxiety may be tempted to move during the procedure, lab personnel will instruct participants to remain still during venipuncture. Participants will be advised that they may take breaks as needed if anxiety becomes overwhelming.

After undergoing the procedure, each participant will be asked to fill out the postprocedure questionnaire and return it to the study team member present in the lab room, who will clean the headset as the participant completes the questionnaire. This questionnaire assesses the patient's pain intensity and level of anxiety with the VAS similar to the VAS assessing pain, as well as the patient's satisfaction with the visit which will be measured utilizing a Likert scale for individual questions.

Being tested
Oculus Go headset with Ocean Rift application
Keywords
virtual reality, venipuncture, blood draw, Oculus Go
Medical subject headings
Pain, Procedural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oculus Go headset with Ocean Rift applicationDevice

    Information already included in arm description

Study groups in NCT04449341
Study groupRoleWhat they receive
Standard care venipuncture with additional of virtual realityExperimentalPatients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset
Receives: Device: Oculus Go headset with Ocean Rift application
Standard care venipuncture without addition of virtual realityNo interventionPatients undergoing blood draw while wearing Oculus Go headset that is turned off

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 months

Secondary outcomes (1)
  1. Procedural Anxiety

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

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2020
  2. Study start10 Jun 2020
  3. Primary completion9 Jul 2020
  4. Study completion9 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04449341
Sponsor's protocol ID
921118
Status last verified
Jul 2021
First submitted
22 Jun 2020
Last updated
13 Jul 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 30618938
  • 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.

    PubMed 15102157
  • 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.

    PubMed 14525749
  • 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.

    PubMed 19786489
  • 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.

    PubMed 24535053
  • 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.

    PubMed 16640481
  • 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.

    PubMed 17711362
  • 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.

    PubMed 11587113
  • 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.

    PubMed 15327820
  • 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.

    PubMed 21779307
  • 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.

    PubMed 20691523
  • 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.

    PubMed 11719741
  • Moore B, Stocks C, Owens P. Trends in Emergency Department Visits, 2006-2014. Healthcare Cost and Utilization Project (HCUP) Statistical Brief #227. 2017

  • 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.

    PubMed 24892202
  • 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.

    PubMed 31889358

Questions about this trial

What is this clinical trial studying?

A study testing Oculus Go headset with Ocean Rift application in people with Procedural Anxiety and Procedural Pain, run by C.R.Darnall Army Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural Pain (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04449341, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in