Decompression SicknessDIVE-PLNCT07855861
Health, Fitness, and Safety Knowledge as Determinants of Adverse Events in Recreational Divers in Poland
An observational study of Decompression Sickness and Barotrauma, run by Medical University of Bialystok at 2 sites in Poland.
Trial summary
This cross-sectional online survey study assesses health status, physical fitness, and safety knowledge as potential determinants of diving-related adverse events among recreational divers in Poland. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Decompression Sickness, Barotrauma, Recreational Diving
- What is being tested?
- Anonymous online questionnaire
- How many people
- 384 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Oct 2026to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult recreational divers residing in Poland who completed at least one dive in the past 24 months, recruited online (convenience sampling) via diving organizations (KDP/CMAS-PTTK, PADI, SSI, IANTD, RAID), dive centers, and themed social-media communities.
Who may be able to join
- Age 18 years or older
- At least one dive within the past 24 months
- Provision of informed consent (checkbox in the survey)
- Residence in Poland (self-declared)
Who cannot join
- Age under 18 years
- No dive within the past 24 months
- No consent to participate
- Incomplete completion of survey sections A-C (eligibility, demographics, diving exposure)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites
Medical University of Bialystok, Department of Respiratory Physiopathology
Bialystok, Podlaskie Voivodeship, 15-540
Lukasz Minarowski, MD, PhD, +48505237045, lukasz.minarowski@umb.edu.pl
Medical University of Bialystok, II Department of Lung Diseases, Lung Cancer and Internal Medicine
Bialystok, Podlaskie Voivodeship, 15-540
Robert Mróz, Prof. MD PhD, +48858316383, lung@umb.edu.pl
Jakub Matuk, BEng
About this study
Official title: Health Status, Physical Activity, and Safety Knowledge as Determinants of Adverse Events Among Recreational Divers in Poland: a Cross-sectional Online Survey Study
This cross-sectional online survey study assesses health status, physical fitness, and safety knowledge as potential determinants of diving-related adverse events among recreational divers in Poland. Recreational diving exposes participants to specific hazards, including decompression sickness (DCS) and barotrauma of the middle ear, sinuses, and lungs. To date, no Polish study has simultaneously evaluated health, physical fitness, theoretical safety knowledge, and the occurrence of adverse events in this population. Adult divers (18 years or older) who completed at least one dive in the past 24 months and reside in Poland complete an anonymous online questionnaire (about 12 to 18 minutes). Physical fitness is estimated as VO2max using the University of Houston Non-Exercise Test (physical activity rating, age, BMI, and sex). Knowledge of DCS, barotrauma, and safe-diving rules is tested at three difficulty levels. The questionnaire also captures diving exposure, certification level, chronic health conditions, and risky behaviours (smoking, alcohol use, and diving beyond certification). The primary endpoint is the proportion of divers reporting at least one diving-related adverse event. Associations with certification level, estimated VO2max, BMI, and other factors are analysed using multivariable logistic regression. The study is non-interventional, anonymous, and carries minimal risk; no clinical procedures or biological sampling are involved.
Read the detailed description
Primary objective: to assess health status, physical fitness, and safety/training knowledge in relation to the occurrence of diving-related adverse events among recreational divers in Poland.
Specific objectives: (1) estimate VO2max from the University of Houston Non-Exercise Test; (2) assess knowledge of decompression sickness, barotrauma, and safe-diving rules at basic, advanced, and emergency-medical levels; (3) determine the frequency of barotrauma and decompression sickness symptoms (clinically confirmed versus presumed); (4) identify risky behaviours (smoking, alcohol use, diving under the influence, and diving beyond certification); (5) assess associations between training level, physical activity, and health and the occurrence of adverse events using multivariable logistic regression.
Hypotheses: H1 - higher certification (Advanced Open Water Diver and above) is associated with better knowledge of diving-related health hazards; H2 - lower estimated VO2max is associated with a higher frequency of adverse events; H3 - risky behaviours are more frequent among lower-certified divers; H4 (exploratory) - decompression sickness risk factors identified in the DAN DSL 2024 dataset are present in the Polish recreational diving population.
Design: cross-sectional, observational, non-interventional study conducted as an anonymous online survey. No clinical procedures, biological sampling, or modification of medical management are involved.
Population and sampling: adults (18 years or older) residing in Poland who completed at least one dive in the past 24 months, recruited online (convenience sampling) via diving organizations, dive centers, and themed social-media communities.
Sample size: target analytic n = 384, derived by triangulation of three methods (proportion estimation n = 323; two-proportion comparison n = 304; logistic-regression events-per-variable rule n = 234), with the binding value (323) plus a 15% non-response buffer.
Data collection and privacy: anonymous online questionnaire hosted on Medical University of Bialystok infrastructure (REDCap); no identifying data and no IP address are stored; processing is GDPR-compliant; data are retained on secured university storage for 5 years and used only for aggregate scientific analysis.
- Conditions
- Decompression Sickness, Barotrauma, Recreational Diving
- Being tested
- Anonymous online questionnaire
- Keywords
- scuba diving, freediving, VO2max, diving safety, adverse events, Poland, diving safety research, physical fitness
- Medical subject headings
- Decompression Sickness, Barotrauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anonymous online questionnaireOther
Anonymous online questionnaire completed once by each participant (about 12 to 18 minutes). It captures demographic data, diving exposure and certification level, chronic health conditions, risky behaviours, estimated VO2max (University of Houston Non-Exercise Test), and a diving-safety knowledge test. No clinical procedures or biological sampling are involved; this is the observational data-collection instrument for the cohort.
| Study group | Role | What they receive |
|---|---|---|
| Recreational divers | Adults (18 years or older) residing in Poland who completed at least one dive in the past 24 months and complete the anonymous online survey. A single observational cohort assessed cross-sectionally. Receives: Other: Anonymous online questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of diving-related adverse events
Proportion of divers reporting at least one diving-related adverse event (barotrauma symptoms, decompression sickness symptoms, or other post-dive health problems) occurring at any time during the participant's diving history up to enrollment (lifetime recall). Reported as a percentage with 95% confidence interval.
Measured: At enrollment (Day 1; single cross-sectional assessment)
Secondary outcomes (4)
Estimated VO2max (University of Houston Non-Exercise Test)
Estimated maximal oxygen uptake (mL/kg/min) calculated from the University of Houston Non-Exercise Test (physical activity rating, age, BMI, and sex), summarized as mean with standard deviation and as median with quartiles, stratified by sex and age.
Measured: At enrollment (Day 1; single cross-sectional assessment)
Diving safety knowledge score
Percentage of correct answers on the diving-hazard knowledge test (decompression sickness, barotrauma, and safe-diving rules), reported overall and at three difficulty levels: basic, advanced, and emergency-medical.
Measured: At enrollment (Day 1; single cross-sectional assessment)
Frequency of risky behaviours
Proportion of divers reporting risky behaviours: tobacco use, alcohol use before diving, diving under the influence of alcohol or other substances, and diving beyond their certification level.
Measured: At enrollment (Day 1; single cross-sectional assessment)
Adjusted odds ratios for diving-related adverse events
Adjusted odds ratios (with 95% confidence intervals) for the occurrence of at least one diving-related adverse event, estimated by multivariable logistic regression, for certification level, estimated VO2max, BMI, and selected risk factors from the DAN DSL 2024 dataset (e.g., sex, thermal comfort, pre-dive physical activity).
Measured: At enrollment (Day 1; single cross-sectional assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompression SicknessStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855861
- Sponsor's protocol ID
- APK.002.228.2026
- Acronym
- DIVE-PL
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2026
- Last updated
- 2 Oct 2026
- 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Status, Physical Activity, and Safety Knowledge as Determinants of Adverse Events Among Recreational Divers in Poland: a Cross-sectional Online Survey Study
- ClinicalTrials.gov ID
- NCT07855861
- Acronym / sponsor ID
- DIVE-PL / APK.002.228.2026
- Conditions
- Decompression Sickness, Barotrauma, Recreational Diving
- Keywords
- scuba diving, freediving, VO2max, diving safety, adverse events, Poland, diving safety research, physical fitness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 2 Oct 2026 (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 cross-sectional online survey study assesses health status, physical fitness, and safety knowledge as potential determinants of diving-related adverse events among recreational divers in Poland. Recreational diving exposes participants to specific hazards, including decompression sickness (DCS) and barotrauma of the middle ear, sinuses, and lungs. To date, no Polish study has simultaneously evaluated health, physical fitness, theoretical safety knowledge, and the occurrence of adverse events in this population. Adult divers (18 years or older) who completed at least one dive in the past 24 months and reside in Poland complete an anonymous online questionnaire (about 12 to 18 minutes). Physical fitness is estimated as VO2max using the University of Houston Non-Exercise Test (physical activity rating, age, BMI, and sex). Knowledge of DCS, barotrauma, and safe-diving rules is tested at three difficulty levels. The questionnaire also captures diving exposure, certification level, chronic health conditions, and risky behaviours (smoking, alcohol use, and diving beyond certification). The primary endpoint is the proportion of divers reporting at least one diving-related adverse event. Associations with certification level, estimated VO2max, BMI, and other factors are analysed using multivariable logistic regression. The study is non-interventional, anonymous, and carries minimal risk; no clinical procedures or biological sampling are involved.
Detailed description
Primary objective: to assess health status, physical fitness, and safety/training knowledge in relation to the occurrence of diving-related adverse events among recreational divers in Poland.
Specific objectives: (1) estimate VO2max from the University of Houston Non-Exercise Test; (2) assess knowledge of decompression sickness, barotrauma, and safe-diving rules at basic, advanced, and emergency-medical levels; (3) determine the frequency of barotrauma and decompression sickness symptoms (clinically confirmed versus presumed); (4) identify risky behaviours (smoking, alcohol use, diving under the influence, and diving beyond certification); (5) assess associations between training level, physical activity, and health and the occurrence of adverse events using multivariable logistic regression.
Hypotheses: H1 - higher certification (Advanced Open Water Diver and above) is associated with better knowledge of diving-related health hazards; H2 - lower estimated VO2max is associated with a higher frequency of adverse events; H3 - risky behaviours are more frequent among lower-certified divers; H4 (exploratory) - decompression sickness risk factors identified in the DAN DSL 2024 dataset are present in the Polish recreational diving population.
Design: cross-sectional, observational, non-interventional study conducted as an anonymous online survey. No clinical procedures, biological sampling, or modification of medical management are involved.
Population and sampling: adults (18 years or older) residing in Poland who completed at least one dive in the past 24 months, recruited online (convenience sampling) via diving organizations, dive centers, and themed social-media communities.
Sample size: target analytic n = 384, derived by triangulation of three methods (proportion estimation n = 323; two-proportion comparison n = 304; logistic-regression events-per-variable rule n = 234), with the binding value (323) plus a 15% non-response buffer.
Data collection and privacy: anonymous online questionnaire hosted on Medical University of Bialystok infrastructure (REDCap); no identifying data and no IP address are stored; processing is GDPR-compliant; data are retained on secured university storage for 5 years and used only for aggregate scientific analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recreational divers | – | Other: Anonymous online questionnaireAdults (18 years or older) residing in Poland who completed at least one dive in the past 24 months and complete the anonymous online survey. A single observational cohort assessed cross-sectionally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult recreational divers residing in Poland who completed at least one dive in the past 24 months, recruited online (convenience sampling) via diving organizations (KDP/CMAS-PTTK, PADI, SSI, IANTD, RAID), dive centers, and themed social-media communities.
Key inclusion criteria (4 listed)
- Age 18 years or older
- At least one dive within the past 24 months
- Provision of informed consent (checkbox in the survey)
- Residence in Poland (self-declared)
Key exclusion criteria (4 listed)
- Age under 18 years
- No dive within the past 24 months
- No consent to participate
- Incomplete completion of survey sections A-C (eligibility, demographics, diving exposure)
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 |
|---|---|---|
| Anonymous online questionnaireAnonymous online questionnaire completed once by each participant (about 12 to 18 minutes). It captures demographic data, diving exposure and certification level, chronic health conditions, risky behaviours, estimated VO2max (University of Houston Non-Exercise Test), and a diving-safety knowledge test. No clinical procedures or biological sampling are involved; this is the observational data-collection instrument for the cohort. | Other | Recreational divers |
Primary outcome
Prevalence of diving-related adverse events
Time frame: At enrollment (Day 1; single cross-sectional assessment)
Proportion of divers reporting at least one diving-related adverse event (barotrauma symptoms, decompression sickness symptoms, or other post-dive health problems) occurring at any time during the participant's diving history up to enrollment (lifetime recall). Reported as a percentage with 95% confidence interval.
4 secondary outcomes
Estimated VO2max (University of Houston Non-Exercise Test)
Time frame: At enrollment (Day 1; single cross-sectional assessment)
Diving safety knowledge score
Time frame: At enrollment (Day 1; single cross-sectional assessment)
Frequency of risky behaviours
Time frame: At enrollment (Day 1; single cross-sectional assessment)
Adjusted odds ratios for diving-related adverse events
Time frame: At enrollment (Day 1; single cross-sectional assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decompression Sickness and Barotrauma, run by Medical University of Bialystok at 2 sites in Poland.
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 4 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: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lukasz Minarowski, MD, PhD (+48 85 831 63 83, lukasz.minarowski@umb.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of diving-related adverse events (time frame: At enrollment (Day 1; single cross-sectional assessment)). 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 2 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.