InjuriesChecklistsNCT01960738
Common Recreational Diving Practices: A Randomized Control Trial Using Pre-Dive Checklist
A study testing A pre-dive checklist in people with Injuries, run by Divers Alert Network at 4 sites in 3 countries.
Trial summary
To evaluate the efficacy of using a pre-dive checklist to prevent the incidence of diving mishaps in recreational divers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Injuries
- What is being tested?
- A pre-dive checklist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,116 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jun 2012to Aug 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Anyone not meeting all of the inclusion criteria
- A diver who did not answer the outcomes questionnaire was later excluded
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Mexico2 sites
Aldora Divers
San Miguel de Cozumel, Quintana Roo
Sand Dollar Sports
San Miguel de Cozumel, Quintana Roo
Cayman Islands1 site
Sunset House
George Town, Grand Cayman
About this study
Official title: 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.
- Conditions
- Injuries
- Being tested
- A pre-dive checklist
- Keywords
- Diving, Water, Recreation, Precursor
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A pre-dive checklistOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group received a pre-dive checklist and a post-dive log Receives: Other: A pre-dive checklist |
| Control | No intervention | The control group received the post-dive log only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
Secondary outcomes (2)
Major mishaps
Major mishaps are a type of mishaps
Measured: One day
Minor Mishaps
Minor mishaps are a type of mishaps
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startJun 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InjuriesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Divers Alert Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Shabbar I Ranapurwala, MPH, Principal investigator, Research Assistant, Medical ResearchPetar J Denoble, MD, DSc, Study director, Vice President, Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960738
- Sponsor's protocol ID
- DAN009-12
- Acronym
- Checklists
- Status last verified
- Oct 2013
- First submitted
- 7 Oct 2013
- Last updated
- 11 Oct 2013
- Results posted
- No
Publications
Ranapurwala SI, Denoble PJ, Poole C, Kucera KL, Marshall SW, Wing S. The effect of using a pre-dive checklist on the incidence of diving mishaps in recreational scuba diving: a cluster-randomized trial. Int J Epidemiol. 2016 Feb;45(1):223-31. doi: 10.1093/ije/dyv292.
PubMed 26534948
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Group Randomized Trial to Evaluate the Efficacy of Using Pre-dive Checklist to Prevent the Incidence of Recreational Scuba Diving Mishaps
- ClinicalTrials.gov ID
- NCT01960738
- Acronym / sponsor ID
- Checklists / DAN009-12
- Conditions
- Injuries
- Keywords
- Diving, Water, Recreation, Precursor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,116 participants (actual)
- Lead sponsor
- Divers Alert NetworkResearch network
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 Oct 2013 (estimated)
- 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.
To evaluate the efficacy of using a pre-dive checklist to prevent the incidence of diving mishaps in recreational divers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: A pre-dive checklistThe intervention group received a pre-dive checklist and a post-dive log |
| Control | No intervention | –The control group received the post-dive log only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Anyone not meeting all of the inclusion criteria
- A diver who did not answer the outcomes questionnaire was later excluded
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 |
|---|---|---|
| A pre-dive checklistThe 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. | Other | Intervention |
Primary outcome
Mishaps
Time frame: One day
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.
2 secondary outcomes
Major mishaps
Time frame: One day
Minor Mishaps
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2013.
- Derived from this study: PubMed 26534948Ranapurwala SI, Denoble PJ, Poole C, Kucera KL, Marshall SW, Wing S. The effect of using a pre-dive checklist on the incidence of diving mishaps in recreational scuba diving: a cluster-randomized trial. Int J Epidemiol. 2016 Feb;45(1):223-31. doi: 10.1093/ije/dyv292.
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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.
Shabbar I Ranapurwala, MPH principal investigator
Research Assistant, Medical Research
Petar J Denoble, MD, DSc study director
Vice President, Medical Research
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A pre-dive checklist in people with Injuries, run by Divers Alert Network at 4 sites in 3 countries.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 11 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Mexico, United States, Cayman Islands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mishaps (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01960738, which also lists 1 linked publication.
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 11 Oct 2013.