Can Virtual Reality Reduce Pain and Anxiety During Blood Draw
Condition: Procedural Anxiety; Procedural Pain
MeSH terms: Pain, Procedural; Anxiety Disorders
Study type: Interventional

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.
    

Intervention name(s): Oculus Go headset with Ocean Rift application
Intervention type(s): Device
Intervention description(s): Information already included in arm description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: virtual reality; venipuncture; blood draw; Oculus Go