Impact of Breathing Interventions on Stress Markers

NCT05825846 | Unknown

• 1 other identifier: Breathing and VR-ASD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Physiological Stress

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

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)

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)

Device: Virtual- reality active shooter drill

Interventions

Virtual- reality active shooter drill DEVICE

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.

Slow breathing 1 (SB1); Slow breathing 2 (SB2)

Eligibility Criteria

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

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
• M. Hunter Martaindale: collaborator
• C. Dillard: collaborator
• S. Hunter: collaborator

Study Sites (1)

Texas State University

San Marcos, Texas, 78666, United States

Location

Related Publications (1)

• 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.

  PMID: 37628548 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Subjects will be randomly assigned to one of two treatments: 1. slow breathing 1 (SB1) 2. slow breathing 2 (SB2)

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: September 23, 2022
• Primary Completion: October 21, 2022
• Study Completion: May 1, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

US (1)