- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01960738
Common Recreational Diving Practices: A Randomized Control Trial Using Pre-Dive Checklist (Checklists)
October 9, 2013 updated by: Divers Alert Network
A Group Randomized Trial to Evaluate the Efficacy of Using Pre-dive Checklist to Prevent the Incidence of Recreational Scuba Diving Mishaps
To evaluate the efficacy of using a pre-dive checklist to prevent the incidence of diving mishaps in recreational divers.
Study Overview
Study Type
Interventional
Enrollment (Actual)
1116
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Grand Cayman
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George Town, Grand Cayman, Cayman Islands
- Sunset House
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Q,roo
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Cozumel, Q,roo, Mexico
- Aldora Divers
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Cozumel, Q,roo, Mexico
- Sand Dollar Sports
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North Carolina
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Wilmington, North Carolina, United States, 28403
- Aquatic Safaris
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Over 18 years of age
- Having a valid Diver Certification
- Deemed fit by the Dive operator to dive on the day of participation
- Planning to dive on the day of participation
- Have basic knowledge of English
Exclusion Criteria:
- Anyone not meeting all of the inclusion criteria
- A diver who did not answer the outcomes questionnaire was later excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention
The intervention group received a pre-dive checklist and a post-dive log
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The pre-dive checklist included a checklist of tasks to be undertaken before the dive, a dive-plan that asked the diver to plan the depth, and amount of gas kept at different levels of diving, and 4 dive tips.
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No Intervention: Control
The control group received the post-dive log only.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mishaps
Time Frame: One day
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Mishaps were reported by scuba divers themselves, at the end of their diving day (the day they were enrolled).
Mishaps are precursors of injuries.
Injuries are less common outcomes (in fact, nobody got injured), hence we used mishaps - which allowed us to test the efficacy of pre-dive checklists, and do so with limited resources.
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One day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Major mishaps
Time Frame: One day
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Major mishaps are a type of mishaps
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One day
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Minor Mishaps
Time Frame: One day
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Minor mishaps are a type of mishaps
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One day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shabbar I Ranapurwala, MPH, Research Assistant, Medical Research
- Study Director: Petar J Denoble, MD, DSc, Vice President, Medical Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
October 7, 2013
First Submitted That Met QC Criteria
October 9, 2013
First Posted (Estimate)
October 11, 2013
Study Record Updates
Last Update Posted (Estimate)
October 11, 2013
Last Update Submitted That Met QC Criteria
October 9, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DAN009-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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