Physiologic Responses to Surprise EventsNCT05664399
Shock Factor: Effects of Surprise on Cardiovascular Responses.
An observational study of Physiologic Responses to Surprise Events, run by University of Manitoba at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiologic Responses to Surprise Events
- What is being tested?
- Surprise events
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 24 Nov 2022to 30 Aug 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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 and healthy.
Who may be able to join
- 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,
- healthy,
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
PlaySafe Productions
Keswick, Ontario
Ted Rankine, 19059605897, tedrankine@rogers.com
Cheryl Gallagher, 14164200453, cheryl@playsafeproductions.com
About this study
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.
Read the detailed description
Participants will participate in one visit to our research facility for 60-90 minutes. During this visit, the following will occur:
General overview
- You will be considered for participation if you respond to the recruitment email from your organization, with an email to indicate interest in participation.
- 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.
- If you respond positively to the second email you will be scheduled to appear at the research facility for an experimental trial.
- 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.
- 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.
- A pre-trial interview will be conducted, and responses will be manually recorded on paper.
- 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).
- You will then put on a climbing harness.
- You will then complete 4 surprise events (see below in the Surprise Events section).
- A post-trial interview will be conducted, and responses will be manually recorded.
- You will change into your regular clothing and be free to leave the research facility.
Surprise Events
- 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.
- For the first event, you will complete one of the following. you will either sit or stand on platforms that are initially stable but will then be allowed to rotate without notice (to simulate tipping a boat or falling off a standup paddleboard).
- For the second event, you will stand on the floor and either hold on to a rope (to simulate holding on to an anchor) or a fishing net (to simulate landing a fish). Without notice, either the rope or fishing net will be quickly pulled downwards. A movable gantry unit (overhead beam) will be used for these first two events. In each case, the self-ratcheting lifeline will be attached to the gantry, and the rope from the lifeline will be attached to the attachment on the back of the climbing harness; this will prevent you from ever falling to the ground.
- The third and fourth events will not involve VR goggles but will involve falling into two dunk tanks with different water temperatures (cool = 22℃; cold = 10℃). The order of temperatures will be randomly assigned to achieve a balanced design. Before each dunking, you will shower in warm water so that your clothing is wet before both dunkings. You will then sit on the platform above one of the tanks. Once you are ready, without notice the dunk tank will be activated and you will be dunked and immediately allowed to exit. After about 5 minutes, the process will then be repeated for the second tank.
- Conditions
- Physiologic Responses to Surprise Events
- Being tested
- Surprise events
- Keywords
- Shock response, Ventilatory response, Cardiac response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surprise eventsOther
Subjects will be subjected to 4 surprise events, two using Virtual Reality simulations of falling out of a boat, and 2 involving falling into dunk tanks of cool and thermoneutral water.
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory response
Changes in ventilation
Measured: 1 day
Cardiac response
Changes in heart rate
Measured: 1 day
Secondary outcomes (1)
Subjective response
Subjective description of surprise experiences
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start24 Nov 2022
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiologic Responses to Surprise EventsStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gordon Giesbrecht, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664399
- Sponsor's protocol ID
- HE2022-0286
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shock Factor: Effects of Surprise on Cardiovascular Responses.
- ClinicalTrials.gov ID
- NCT05664399
- Acronym / sponsor ID
- HE2022-0286
- Conditions
- Physiologic Responses to Surprise Events
- Keywords
- Shock response, Ventilatory response, Cardiac response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 23 Dec 2022 (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.
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.
Detailed description
Participants will participate in one visit to our research facility for 60-90 minutes. During this visit, the following will occur:
General overview
- You will be considered for participation if you respond to the recruitment email from your organization, with an email to indicate interest in participation.
- 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.
- If you respond positively to the second email you will be scheduled to appear at the research facility for an experimental trial.
- 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.
- 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.
- A pre-trial interview will be conducted, and responses will be manually recorded on paper.
- 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).
- You will then put on a climbing harness.
- You will then complete 4 surprise events (see below in the Surprise Events section).
- A post-trial interview will be conducted, and responses will be manually recorded.
- You will change into your regular clothing and be free to leave the research facility.
Surprise Events
- 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.
- For the first event, you will complete one of the following. you will either sit or stand on platforms that are initially stable but will then be allowed to rotate without notice (to simulate tipping a boat or falling off a standup paddleboard).
- For the second event, you will stand on the floor and either hold on to a rope (to simulate holding on to an anchor) or a fishing net (to simulate landing a fish). Without notice, either the rope or fishing net will be quickly pulled downwards. A movable gantry unit (overhead beam) will be used for these first two events. In each case, the self-ratcheting lifeline will be attached to the gantry, and the rope from the lifeline will be attached to the attachment on the back of the climbing harness; this will prevent you from ever falling to the ground.
- The third and fourth events will not involve VR goggles but will involve falling into two dunk tanks with different water temperatures (cool = 22℃; cold = 10℃). The order of temperatures will be randomly assigned to achieve a balanced design. Before each dunking, you will shower in warm water so that your clothing is wet before both dunkings. You will then sit on the platform above one of the tanks. Once you are ready, without notice the dunk tank will be activated and you will be dunked and immediately allowed to exit. After about 5 minutes, the process will then be repeated for the second tank.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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 and healthy.
Key inclusion criteria (7 listed)
- 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,
- healthy,
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surprise eventsSubjects will be subjected to 4 surprise events, two using Virtual Reality simulations of falling out of a boat, and 2 involving falling into dunk tanks of cool and thermoneutral water. | Other | – |
Primary outcome
Respiratory response
Time frame: 1 day
Changes in ventilation
Cardiac response
Time frame: 1 day
Changes in heart rate
1 secondary outcome
Subjective response
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: No
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.
Gordon Giesbrecht, PhD principal investigator
University of Manitoba
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 Physiologic Responses to Surprise Events, run by University of Manitoba at 1 site in Canada.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Dec 2022. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gordon Giesbrecht, PhD (2049956599, gordon.giesbrecht@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory response (time frame: 1 day). The study lists 2 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 23 Dec 2022.