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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01960738
Other study ID # DAN009-12
Secondary ID
Status Completed
Phase N/A
First received October 7, 2013
Last updated October 9, 2013
Start date June 2012
Est. completion date August 2012

Study information

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

Clinical Trial Summary

To evaluate the efficacy of using a pre-dive checklist to prevent the incidence of diving mishaps in recreational divers.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
A pre-dive checklist
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Divers Alert Network

Countries where clinical trial is conducted

United States,  Cayman Islands,  Mexico, 

Outcome

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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