Impact of Breathing Interventions on Stress Markers

Impact of Slow Breathing on Markers of Stress in Response to a Virtual Reality Active Shooter Drill

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?

Study Overview

• Status: Active, not recruiting
• Conditions: Physiological Stress
• Intervention / Treatment: Device: Virtual- reality active shooter drill

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Marcos, Texas, United States, 78666
      • Texas State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• apparently healthy, aged 18-39
• free from any known cardiovascular or metabolic diseases,
• free from any major stressors within the last 30 days such as birth of a child, abortion, or divorce.

Exclusion Criteria:

• subjects are required to not have a history of motion sickness, or vertigo
• not previously diagnosed with a brain injury or epilepsy, asthma, or currently taking psychological medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Slow breathing 1 (SB1); 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)	Device: Virtual- reality active shooter drill; The stress protocol used for this experiment utilized a previously studied virtual reality active shooter drill (VR-ASD). The VR-ASD scenario (~2 min) involves the participant physically walking down a ~10-foot-long virtual hallway where they will encounter wounded victims. 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, the participant will "fire" a shot, and the shooter will fall after being shot.
Experimental: Slow breathing 2 (SB2); Four second inhale through the nose into the diaphragm followed by a two second exhale, repeat (~50 breath cycles within the 5 min intervention)	Device: Virtual- reality active shooter drill; The stress protocol used for this experiment utilized a previously studied virtual reality active shooter drill (VR-ASD). The VR-ASD scenario (~2 min) involves the participant physically walking down a ~10-foot-long virtual hallway where they will encounter wounded victims. 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, the participant will "fire" a shot, and the shooter will fall after being shot.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
salivary secretory IgA	SIgA is a marker of immune function and salivary SIgA concentrations tend to increase when exposed to stress	Up to 8 months
salivary alpha amylase	salivary alpha amylase is an enzyme involved in digestive processes. Amylase concentration in saliva have been shown to reflect sympathetic stress. Thus, as sympathetic stress increases, salivary amylase concentrations tend to increase.	up to 8months
salivary cortisol	salivary cortisol is a marker of stress which reflects activation on the hypothalamic pituitary adrenal axis	up to 8 months
heart rate	heart rate reflects activity from parasympathetic and sympathetic nervous system and increases when exposed to stress	Up to 8 months
State trait anxiety inventory	state anxiety inventory is a subjective scale which includes six short statements such as "I feel calm" or "I feel tense" and composite scores of participant responses are used for analysis. Higher values reflect higher subjected anxiety.	Up to 8 months
systolic and diastolic blood pressure	Blood pressure measures the force and pressure of blood in the arteries. When stressed the activation of the autonomic nervous system produces vasoconstricting hormones and releases them when exposed to stress.	Up to 8 months

Collaborators and Investigators

• Sponsor: Texas State University
• Collaborators: M. Hunter Martaindale; C. Dillard; S. Hunter

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Actual): October 21, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Breathing and VR-ASD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No