Trial Outcomes & Findings for Can Virtual Reality Reduce Pain and Anxiety During Blood Draw (NCT NCT04449341)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

59 participants

Primary outcome timeframe

2 months

Results posted on

2021-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Virtual Reality Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset Oculus Go headset with Ocean Rift application: Information already included in arm description	Control Patients undergoing blood draw while wearing Oculus Go headset that is turned off
Overall Study STARTED	31	28
Overall Study COMPLETED	30	28
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Virtual Reality Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset Oculus Go headset with Ocean Rift application: Information already included in arm description	Control Patients undergoing blood draw while wearing Oculus Go headset that is turned off
Overall Study Protocol Violation	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Care Venipuncture With Additional of Virtual Reality n=30 Participants Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset Oculus Go headset with Ocean Rift application: Information already included in arm description	Standard Care Venipuncture Without Addition of Virtual Reality n=28 Participants Patients undergoing blood draw while wearing Oculus Go headset that is turned off	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=28 Participants	0 Participants n=58 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=30 Participants	28 Participants n=28 Participants	58 Participants n=58 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants	0 Participants n=28 Participants	0 Participants n=58 Participants
Sex/Gender, Customized Unknown	30 participants n=30 Participants	28 participants n=28 Participants	58 participants n=58 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 2 months

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

Outcome measures

Outcome measures
Measure	Standard Care Venipuncture With Additional of Virtual Reality n=30 Participants Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset Oculus Go headset with Ocean Rift application: Information already included in arm description	Standard Care Venipuncture Without Addition of Virtual Reality n=28 Participants Patients undergoing blood draw while wearing Oculus Go headset that is turned off
Procedural Pain	6.50 score on a scale Interval 0.25 to 30.75	5.00 score on a scale Interval 1.0 to 24.25

SECONDARY outcome

Timeframe: 2 months

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

Outcome measures

Outcome measures
Measure	Standard Care Venipuncture With Additional of Virtual Reality n=31 Participants Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset Oculus Go headset with Ocean Rift application: Information already included in arm description	Standard Care Venipuncture Without Addition of Virtual Reality n=28 Participants Patients undergoing blood draw while wearing Oculus Go headset that is turned off
Procedural Anxiety	5 score on a scale Interval 1.0 to 24.25	6.5 score on a scale Interval 0.25 to 30.75

Adverse Events

Standard Care Venipuncture With Additional of Virtual Reality

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care Venipuncture Without Addition of Virtual Reality

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthew Perdue

Carl R Darnall Army Medical Center

Phone: (254) 553-4653

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place