Clinical trial NCT04449341: Can Virtual Reality Reduce Pain and Anxiety During Blood Draw
Official title: Can Virtual Reality Reduce Patient's Pain, Improve Patient's Experience, and Reduce Procedure Related Anxiety With Venipuncture? A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Anxiety
Procedural Pain
Keywords: virtual reality
venipuncture
blood draw
Oculus Go
Lead sponsor: C.R.Darnall Army Medical Center
Sponsor class: FED
First posted: 2020-06-26
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Procedural Pain
timeFrame: 2 months
Secondary outcomes:
measure: Procedural Anxiety
timeFrame: 2 months
Other outcomes:
Locations:
city: Fort Hood
country: United States
facility: Carl R Darnall Army Medical Center
state: Texas
Study officials:
affiliation: C.R.Darnall Army Medical Center
name: Matthew J Perdue, PA
role: PRINCIPAL_INVESTIGATOR
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