Injuries Clinical Trial
— ChecklistsOfficial title:
A Group Randomized Trial to Evaluate the Efficacy of Using Pre-dive Checklist to Prevent the Incidence of Recreational Scuba Diving Mishaps
Verified date | October 2013 |
Source | Divers Alert Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
To evaluate the efficacy of using a pre-dive checklist to prevent the incidence of diving mishaps in recreational divers.
Status | Completed |
Enrollment | 1116 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Cayman Islands | Sunset House | George Town | Grand Cayman |
Mexico | Aldora Divers | Cozumel | Q,roo |
Mexico | Sand Dollar Sports | Cozumel | Q,roo |
United States | Aquatic Safaris | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Divers Alert Network |
United States, Cayman Islands, Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mishaps | 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. | One day | No |
Secondary | Major mishaps | Major mishaps are a type of mishaps | One day | No |
Secondary | Minor Mishaps | Minor mishaps are a type of mishaps | One day | No |
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