Physiological StressNCT05825846
Impact of Breathing Interventions on Stress Markers
A study testing Virtual- reality active shooter drill in people with Physiological Stress, run by Texas State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological Stress
- What is being tested?
- Virtual- reality active shooter drill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2022to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- what is the impact of a controlled breathing intervention and virtual reality active shooter drill on markers of subjective and biological stress?
Read the 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.
- Conditions
- Physiological Stress
- Being tested
- Virtual- reality active shooter drill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual- reality active shooter drillDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Slow breathing 1 (SB1) | Experimental | 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) Receives: Device: Virtual- reality active shooter drill |
| Slow breathing 2 (SB2) | Experimental | Four second inhale through the nose into the diaphragm followed by a two second exhale, repeat (~50 breath cycles within the 5 min intervention) Receives: Device: Virtual- reality active shooter drill |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary secretory IgA
SIgA is a marker of immune function and salivary SIgA concentrations tend to increase when exposed to stress
Measured: 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.
Measured: up to 8months
salivary cortisol
salivary cortisol is a marker of stress which reflects activation on the hypothalamic pituitary adrenal axis
Measured: up to 8 months
heart rate
heart rate reflects activity from parasympathetic and sympathetic nervous system and increases when exposed to stress
Measured: 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.
Measured: 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.
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start23 Sep 2022
- Primary completion21 Oct 2022
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physiological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly assigned to one of two treatments: 1. slow breathing 1 (SB1) 2. slow breathing 2 (SB2)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas State University
- Sponsor type
- University, hospital or other
- Collaborators
- M. Hunter Martaindale, C. Dillard, S. Hunter
- Responsible party
- Principal investigator, Matt McAllister, Texas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825846
- Sponsor's protocol ID
- Breathing and VR-ASD
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dillard CC, Martaindale H, Hunter SD, McAllister MJ. Slow Breathing Reduces Biomarkers of Stress in Response to a Virtual Reality Active Shooter Training Drill. Healthcare (Basel). 2023 Aug 21;11(16):2351. doi: 10.3390/healthcare11162351.
PubMed 37628548
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Slow Breathing on Markers of Stress in Response to a Virtual Reality Active Shooter Drill
- ClinicalTrials.gov ID
- NCT05825846
- Acronym / sponsor ID
- Breathing and VR-ASD
- Conditions
- Physiological Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Texas State UniversityUniversity, hospital or other
- Collaborators
- M. Hunter Martaindale, C. Dillard, S. Hunter
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- May 2023 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- what is the impact of a controlled breathing intervention and virtual reality active shooter drill on markers of subjective and biological stress?
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to one of two treatments: 1. slow breathing 1 (SB1) 2. slow breathing 2 (SB2)
| Arm | Type | Receives |
|---|---|---|
| Slow breathing 1 (SB1) | Experimental | Device: Virtual- reality active shooter drillFour 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 (SB2) | Experimental | Device: Virtual- reality active shooter drillFour second inhale through the nose into the diaphragm followed by a two second exhale, repeat (~50 breath cycles within the 5 min intervention) |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual- reality active shooter drillThe 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. | Device | Slow breathing 1 (SB1), Slow breathing 2 (SB2) |
Primary outcome
salivary secretory IgA
Time frame: Up to 8 months
SIgA is a marker of immune function and salivary SIgA concentrations tend to increase when exposed to stress
salivary alpha amylase
Time frame: up to 8months
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.
salivary cortisol
Time frame: up to 8 months
salivary cortisol is a marker of stress which reflects activation on the hypothalamic pituitary adrenal axis
heart rate
Time frame: Up to 8 months
heart rate reflects activity from parasympathetic and sympathetic nervous system and increases when exposed to stress
State trait anxiety inventory
Time frame: Up to 8 months
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.
systolic and diastolic blood pressure
Time frame: Up to 8 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Derived from this study: PubMed 37628548Dillard CC, Martaindale H, Hunter SD, McAllister MJ. Slow Breathing Reduces Biomarkers of Stress in Response to a Virtual Reality Active Shooter Training Drill. Healthcare (Basel). 2023 Aug 21;11(16):2351. doi: 10.3390/healthcare11162351.
Related trials for Physiological Stress
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Not yet recruiting
Eye Covering and White Noise During Nasogastric Tube Insertion in Preterm Infants
Preterm Infants
Recruiting
Effects of Moderate Exercise and Cyclic Sighing on Stress, Cognition and Physiological Markers in Young Adults
Stress
Not yet recruiting
Psychological and Physiological Effects of Three-Minute Breathing Space Meditation in UPM Postgraduate Students
Stress, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual- reality active shooter drill in people with Physiological Stress, run by Texas State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salivary secretory IgA (time frame: Up to 8 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05825846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.