Impact of Combined Stress on Biomarkers of Stress

NCT06680908 | Completed

• 1 other identifier: Combined Stress
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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 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?

Conditions

Physiological Stress

Outcome Measures

Primary Outcomes (4)

• Salivary secretory IgA

  SIgA is a marker of immune function and salivary SIgA concentrations tend to increase when exposed to stress

  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.

  Up to 6 months

• Heart Rate

  heart rate reflects activity from parasympathetic and sympathetic nervous system and increases when exposed to stress

  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.

  Up to 6 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects who participated were 18-39, healthy, college aged students recruited from Texas State University campus.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas State University: lead
• Texas State University, San Marcos: collaborator

Study Sites (1)

Texas State Univeristy

San Marcos, Texas, 78666, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

the participants collected their own saliva using the passive drool method. Each sample was collected by allowing saliva to pool in mouth, by tilting their head forward and gently guiding saliva into a tube. Each sample was approximately .1 tbsp (1.5mL) of saliva.

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: January 20, 2024
• Primary Completion: May 4, 2024
• Study Completion: May 4, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)