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临床试验/NCT05825846
NCT05825846进行中(未招募)不适用

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

Texas State University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
2
主要终点
salivary alpha amylase

研究概览

简要总结

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?

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

salivary alpha amylase

时间窗: 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

时间窗: up to 8 months

salivary cortisol is a marker of stress which reflects activation on the hypothalamic pituitary adrenal axis

heart rate

时间窗: Up to 8 months

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

State trait anxiety inventory

时间窗: 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

时间窗: 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.

salivary secretory IgA

时间窗: Up to 8 months

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matt McAllister

Associate Professor

Texas State University

研究点 (2)

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