Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05825846 |
Other study ID # |
Breathing and VR-ASD |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 23, 2022 |
Est. completion date |
May 2023 |
Study information
Verified date |
April 2023 |
Source |
Texas State University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to examine the effects of slow breathing breathing on
markers of stress in healthy college aged individuals. The breathing intervention is
performed for five minutes pre and post a virtual reality active shooter drill.
The main question to answer is:
1) what is the impact of a controlled breathing intervention and virtual reality active
shooter drill on markers of subjective and biological stress?
Description:
For this study participants will be randomly assigned either slow breathing 1 [(SB1); four
second inhale, two second pause, four second exhale, two second pause, repeat for five
minutes] or slow breathing 2 [(SB2); four second inhale, two second exhale, repeat for five
minutes]. The breathing intervention will take place five minutes prior to the start of the
virtual reality based active shooter drill. Researchers will compare the two groups in terms
of change in heart rate (HR), blood pressure (BP) subjective stress [(SAI); state-trait
anxiety inventory], and salivary markers of stress before and after the breathing
intervention and virtual reality active shooter drill (VR-ASD).
All procedures were reviewed and approved by the University Institutional Review Board.
Experimental procedures upon arrival to the testing site, subjects will be instructed to
rinse their mouth with water and rest in a quiet room for 10 minutes. Immediately after the
10 minutes of rest period, an initial saliva sample, HR & BP (Suntech, Hauppauge, NY, USA)
and SAI measures were collected (30 min prior to VR-ASD). Throughout the experimental session
HR, BP, SAI, and saliva samples will be collected a total of four times : 1) 30 minutes prior
to start of the VR-ASD, 2) 5 minutes prior to the start of the VR-ASD (immediately before the
breathing intervention) 3) 5 minutes post VR-ASD (immediately post breathing intervention),
and 4) 30 minutes post VR-ASD.
Virtual Reality- Active Shooter Drill (VR-ASD):
This is a virtually reality simulation, the participant will put on the VR headset and carry
a Glock 17 training pistol, they will be able to physically move through the entire ASD
without interruption. The VR lab is larger than the virtual environment (~35 x 20 ft). The
participant will physically walk down a ~10-foot-long virtual hallway where they will
encounter 2 simulated wounded victims. One will be on the ground with traumatic injuries and
the second victim will 'run' out of the attack room with gunshot wounds to his/her left arm
and leg. Once at the threshold of to the attack room, they will observe one victim on the
ground with a traumatic head injury and the shooter firing his handgun at the last victim. If
the subject hadn't fired his/her weapon yet, the shooter would turn toward the participant to
elicit a response, the participant will " fire" a shot if needed. The shooter will fall after
being shot.
Slow breathing 1 ("Box" breathing/slow breathing): Four second inhale through the nasal +
hold two seconds + four second exhale through the mouth + hold for two seconds, repeat (~25
breath cycles within the 5 min intervention) Slow breathing 2: Four second inhale through the
nose into the diaphragm followed by a two second exhale, repeat (~50 breath cycles within the
5 min intervention)
Breathing Instructional video The lead researcher will provide a 5- minute instructional
video over randomly assigned breathing method to the participant prior to starting the
breathing intervention. The instructional video will include a visual of the researcher
performing the breathing intervention alongside a voice over with a countdown on the screen
to go-along with the breathing tempo. A researcher will be in the room with the participant
counting their breaths per minute to make sure they are keeping up with the breathing tempo
and ending at the appropriate time. If the participant is unable to keep up with the
breathing tempo they will be asked to discontinue.