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临床试验/NCT05664399
NCT05664399招募中不适用

Shock Factor: Effects of Surprise on Cardiovascular Responses.

University of Manitoba1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Respiratory response

研究概览

简要总结

This research will determine the breathing, heart rate and other responses to four surprise events. For two events, virtual reality goggles will be used to create a realistic experience of falling out of a boat and rolling out of a boat or falling of a paddleboard. Two final events will involve falling into a dunk tank with either cool (20℃) or cold (10℃) water.

详细描述

Participants will participate in one visit to our research facility for 60-90 minutes. During this visit, the following will occur:

General overview

  1. You will be considered for participation if you respond to the recruitment email from your organization, with an email to indicate interest in participation.
  2. You will be sent an initial email asking if you would be willing to receive 4 files related to the study: They are Screening Questionnaire; Subject Information Form, Get Active Questionnaire; and Informed Consent.
  3. If you respond positively to the second email you will be scheduled to appear at the research facility for an experimental trial.
  4. Once you have arrived at the facility you will be asked to sign this Informed Consent Form if you have not already submitted it via email.
  5. You will be asked if you voluntarily agree to be video recorded for the creation of educational videos for public use. If you do agree, you will be asked to sign a separate Audio-Video Release.
  6. A pre-trial interview will be conducted, and responses will be manually recorded on paper.
  7. You will then put on a special shirt (Hexoskin Shirt) over your swimsuit. This suit measures heart rate and breathing (indicated by the expansion of your chest).
  8. You will then put on a climbing harness.
  9. You will then complete 4 surprise events (see below in the Surprise Events section).
  10. A post-trial interview will be conducted, and responses will be manually recorded.
  11. You will change into your regular clothing and be free to leave the research facility.

Surprise Events

  1. The first two events will involve wearing virtual reality (VR) goggles. The goggles will have visual presentations that coincide with the corresponding events that you are participating in. You will also wear a full climbing harness (including a chest harness) which is connected via climbing rope to a self-ratcheting lifeline that is firmly anchored to an overhead beam. The lifeline is commonly used to provide fall protection for workers at height; when the wearer falls, you will be slowly lowered to the ground. With this configuration, when you quickly rotate sideways or fall forward, you will experience the initial surprise motion, but your fall will be arrested by the lifeline. As an added safety measure, a gymnastics mat will be placed on the floor.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female boaters (anyone who takes 2 or more boat trips per year in small recreational boats (including powered and unpowered),
  • 18-65 years old,
  • do not have any allergic responses to water (aquagenic urticaria) or cold (cold urticaria),
  • do not have a history of uncontrolled panic in water, or phobia or water (aquaphobia), and
  • are cleared based on responses to the Get Active Questionnaire.
  • Subjects will not have to be swimmers

排除标准

  • Anyone who has a history of uncontrolled panic in water, or phobia of water (aquaphobia),
  • allergic responses to water (aquagenic urticaria) or cold (cold urticaria),
  • outside the 18-65 year old age bracket, and
  • not cleared based on responses to the Get Active Questionnaire.

结局指标

主要结局

Respiratory response

时间窗: 1 day

Changes in ventilation

Cardiac response

时间窗: 1 day

Changes in heart rate

次要结局

  • Subjective response(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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