Physiological StressNCT06680908
Impact of Combined Stress on Biomarkers of Stress
An observational study of 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 combined mental and physical stress on biomarkers of stress in healthy college aged individuals. The mental stress performed is a virtual reality active shooter drill that lasts ~3 minutes, and the physical stressor is a Ruffier squat test accompanied with… 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
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2024to 4 May 2024
- Phase
- Observational
- 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
Study population: Subjects who participated were 18-39, healthy, college aged students recruited from Texas State University campus.
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: Investigating the Effects of Combined Mental and Physical Stress
The goal of this clinical trial is to examine the effects of combined mental and physical stress on biomarkers of stress in healthy college aged individuals. The mental stress performed is a virtual reality active shooter drill that lasts ~3 minutes, and the physical stressor is a Ruffier squat test accompanied with jump rope, in order to examine the effects of combined stress versus physical stress alone. The main question to answer is:
- What is the impact of combined stress in comparison to a single stressor on markers of subjective and biological stress?
Read the detailed description
This study randomly assigned subjects to 2 groups; group one was assigned to experience the Ruffier squat test and jump rope, a physical stressor, alone. While group two was assigned to a dual stressor, the Ruffier squat test and jump rope, followed by the virtual reality active shooter drill (VR-ASD). The stress tasks marked the midway point in the study, prior to and following the stress task, researchers collected heart rate (HR), state inventory assessment (SAI), and a salivary sample in order to assess differences in perceived and physiological stress levels.
All procedures from this project were reviewed and approved by the University Institutional Review Board.
The experimental procedures began upon arrival to the testing site where the subjects read and signed the informed consent document, had their body composition measurements taken by the inbody, as well as height taken, they were then exported to the gymnasium where they were instructed to rinse their mouth with water and rest. There was 4 collection periods in this study, where a SAI, HR, and saliva sample was taken; 1) 30 minutes pre exercise test 2) immediately pre exercise test 3) 5 minutes post exercise test 4) 30 minutes post exercise.
Virtual Reality- Active Shooter Drill (VR-ASD):
The VR-ASD is a virtual reality simulation that required the subject to wear a VR headset, carry a Glock 17 training pistol, and navigate the VR environment by physically moving on their own without interruption. The VR was performed in an open gymnasium, much larger than the scenario, to allow for ample room to roam the scenario. Following a familiarization period, the subject is then told they are a responding officer to an active shooter where they will be asked to find and eliminate the target. The subject then physically walked down a 10-foot hallway in VR where they encountered 2 victims of the shooting. One of the victims has traumatic injuries, while the other victim runs out of the room with the shooter with gunshot wounds to their arm and leg. Once the subject reaches the room with the shooter, they will observe a victim with a traumatic head injury, and the shooter firing his handgun at the last victim. If the subject hadn't fired their weapon at this point, the shooter would then begin open firing at the participant. Once the shooter had been shot by the participant, the shooter fell to the ground and the scenario ended.
Exercise test:
The participants performed 30 squats in 45 seconds with a tempo set by a metronome at 80 bpm. Each repetition consisted of squatting down to 90-degree knee flexion and back up with their back straight and arms extended in front. Failure to meet 90 degree flexion after two warnings resulted in disqualification and they were not be able to continue the exercise intervention due to not meeting the criteria. The squat test is completed in 3 minutes. The participants sat for five minutes before having their resting HR recorded, they then performed the 30 squats and had their HR recorded immediately following, then waited 60 seconds before getting their final HR recording to complete the squat test. Following, they were then instructed to perform 2 sets of 20 jump ropes under 90 seconds.
- Conditions
- Physiological Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dual stress challenge group: VR-ASD & Exercise test | VR-ASD: ~90 second VR scenario, subject was instructed that they are a responding officer to an active shooter, and they must find and eliminate the shooter. They then must walk down a 10 foot hallway, find the shooter, and take them out with their Glock 17 training pistol. Exercise Test: 30 squats in 45 seconds, tempo set by metronome at 80bpm. Each rep must consist of 90 degree knee flexion with their back straight. Following, the subject then does 2 sets of 20 jump ropes. | |
| Exercise Test only | Exercise Test: 30 squats in 45 seconds, tempo set by metronome at 80bpm. Each rep must consist of 90 degree knee flexion with their back straight. Following, the subject then does 2 sets of 20 jump ropes. |
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 6 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 6 months
Heart Rate
heart rate reflects activity from parasympathetic and sympathetic nervous system and increases when exposed to stress
Measured: Up to 6 months
State 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 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start20 Jan 2024
- Primary completion4 May 2024
- Study completion4 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas State University
- Sponsor type
- University, hospital or other
- Collaborators
- Texas State University, San Marcos
- Responsible party
- Principal investigator, Matt McAllister, Texas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680908
- Sponsor's protocol ID
- Combined Stress
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Consent was not obtained for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Combined Mental and Physical Stress
- ClinicalTrials.gov ID
- NCT06680908
- Acronym / sponsor ID
- Combined Stress
- Conditions
- Physiological Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Texas State UniversityUniversity, hospital or other
- Collaborators
- Texas State University, San Marcos
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 4 May 2024 (actual)
- Study completion
- 4 May 2024 (actual)
- First posted
- 8 Nov 2024 (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 combined mental and physical stress on biomarkers of stress in healthy college aged individuals. The mental stress performed is a virtual reality active shooter drill that lasts ~3 minutes, and the physical stressor is a Ruffier squat test accompanied with jump rope, in order to examine the effects of combined stress versus physical stress alone. The main question to answer is:
- What is the impact of combined stress in comparison to a single stressor on markers of subjective and biological stress?
Detailed description
This study randomly assigned subjects to 2 groups; group one was assigned to experience the Ruffier squat test and jump rope, a physical stressor, alone. While group two was assigned to a dual stressor, the Ruffier squat test and jump rope, followed by the virtual reality active shooter drill (VR-ASD). The stress tasks marked the midway point in the study, prior to and following the stress task, researchers collected heart rate (HR), state inventory assessment (SAI), and a salivary sample in order to assess differences in perceived and physiological stress levels.
All procedures from this project were reviewed and approved by the University Institutional Review Board.
The experimental procedures began upon arrival to the testing site where the subjects read and signed the informed consent document, had their body composition measurements taken by the inbody, as well as height taken, they were then exported to the gymnasium where they were instructed to rinse their mouth with water and rest. There was 4 collection periods in this study, where a SAI, HR, and saliva sample was taken; 1) 30 minutes pre exercise test 2) immediately pre exercise test 3) 5 minutes post exercise test 4) 30 minutes post exercise.
Virtual Reality- Active Shooter Drill (VR-ASD):
The VR-ASD is a virtual reality simulation that required the subject to wear a VR headset, carry a Glock 17 training pistol, and navigate the VR environment by physically moving on their own without interruption. The VR was performed in an open gymnasium, much larger than the scenario, to allow for ample room to roam the scenario. Following a familiarization period, the subject is then told they are a responding officer to an active shooter where they will be asked to find and eliminate the target. The subject then physically walked down a 10-foot hallway in VR where they encountered 2 victims of the shooting. One of the victims has traumatic injuries, while the other victim runs out of the room with the shooter with gunshot wounds to their arm and leg. Once the subject reaches the room with the shooter, they will observe a victim with a traumatic head injury, and the shooter firing his handgun at the last victim. If the subject hadn't fired their weapon at this point, the shooter would then begin open firing at the participant. Once the shooter had been shot by the participant, the shooter fell to the ground and the scenario ended.
Exercise test:
The participants performed 30 squats in 45 seconds with a tempo set by a metronome at 80 bpm. Each repetition consisted of squatting down to 90-degree knee flexion and back up with their back straight and arms extended in front. Failure to meet 90 degree flexion after two warnings resulted in disqualification and they were not be able to continue the exercise intervention due to not meeting the criteria. The squat test is completed in 3 minutes. The participants sat for five minutes before having their resting HR recorded, they then performed the 30 squats and had their HR recorded immediately following, then waited 60 seconds before getting their final HR recording to complete the squat test. Following, they were then instructed to perform 2 sets of 20 jump ropes under 90 seconds.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual stress challenge group: VR-ASD & Exercise test | – | –VR-ASD: ~90 second VR scenario, subject was instructed that they are a responding officer to an active shooter, and they must find and eliminate the shooter. They then must walk down a 10 foot hallway, find the shooter, and take them out with their Glock 17 training pistol. Exercise Test: 30 squats in 45 seconds, tempo set by metronome at 80bpm. Each rep must consist of 90 degree knee flexion with their back straight. Following, the subject then does 2 sets of 20 jump ropes. |
| Exercise Test only | – | –Exercise Test: 30 squats in 45 seconds, tempo set by metronome at 80bpm. Each rep must consist of 90 degree knee flexion with their back straight. Following, the subject then does 2 sets of 20 jump ropes. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects who participated were 18-39, healthy, college aged students recruited from Texas State University campus.
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.
Primary outcome
Salivary secretory IgA
Time frame: Up to 6 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 6 months
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.
Heart Rate
Time frame: Up to 6 months
heart rate reflects activity from parasympathetic and sympathetic nervous system and increases when exposed to stress
State Anxiety Inventory
Time frame: Up to 6 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No. Consent was not obtained for data sharing.
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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?
An observational study of 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: finished, as of the sponsor's last update on 8 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2024.