- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06555666
Practice of Scuba Diving by as Many People as Possible: Effect of Medical Assessment to Provide a Suitable and Individualised Framework for Practice (Plongée Santé) (Healthy-diving)
Practice of Scuba Diving by as Many People as Possible: Effect of Medical Assessment to Provide a Suitable and Individualised Framework for Practice
The study focuses on the practice of recreational scuba diving by people who have obtained medical advice for their practice in the hyperbaric and underwater medicine department of the Brest University Hospital. These people may have no health problem or on the contrary consult because they have a pathology and want a medical advice on the impact of this health problem on their practice: this is the case for about the half of these consultants.
For the latter, there are no data concerning the relevance of a medical advice response and a proposal for an appropriate technical practice framework (restriction of dive depth, duration, etc.). A relevant answer results in a practice without diving accidents or decompensation of the pathology and a decision accepted and respected by the practitioner.
This study aims to analyze the state of health of the service's consultants and medical recommendations formulated at the end of this consultation, by retrospective analysis of the consultation files, and to interview the consultants on their practice of diving, their state of health and any problems encountered since their consultation.
The purpose is to validate the hypothesis that a practice of underwater diving is possible and beneficial, with an acceptable risk in case of a risk factor or pathology using a framework of advice and restrictions of adapted and individualized practice ("sport for health").
Study Overview
Status
Conditions
Detailed Description
This is a single-center retrospective study on health data. The methodology includes a collection of data on health and practice of scuba diving, figuring on the medical consultation files and then carrying out a telephone interview of people seen in diving medicine consultation between 01/01/2015 and on 12/31/2018 in the hyperbaric and underwater medicine department of the Brest University hospital.
One month before the start of these interviews, an information letter on the study is sent by post, giving the possibility of opposing it.
The main evaluation criteria are the number of dives carried out since the consultation (and the average number of dives per year of practice), and the number of accidents or incidents during the practice of recreational scuba diving in the framework proposed, during the months or years following the medical consultation The secondary evaluation criteria are the evolution of the chronic pathology, the evolution of health status in general, the number of hours of practice of a physical and sport activity per week, the respect of the technical practice framework recommended.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Brest, France, 29609
- CHU de Brest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The population include new potential divers and confirmed divers who asked for a medical advice about their practice of diving.
About a half of this population have had a diving injury or has a chronic pathology.
Description
Inclusion Criteria:
- People who asked for a medical advice for the diving practice in a consultation in the hyperbaric and underwater medicine department of the Brest University hospital from 2015/01/01 to 2018/12/31
Exclusion Criteria:
- refusal
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
injury during diving practice since the consultation
Time Frame: 1 month
|
type and number of diving injury
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
evolution of health status
Time Frame: 1 month
|
qualitative scale : new pathology, worse, stable or better
|
1 month
|
|
evolution of the chronic pathology
Time Frame: 1 month
|
qualitative scale : worse, stable, recurrence or remission
|
1 month
|
|
duration of physical or sport practice per week
Time Frame: 1 month
|
in hours per week
|
1 month
|
|
medical recommendation respect
Time Frame: 1 month
|
for each participant, comparison between the medical recommended practice framework and the actual practice declared; then percentage of participant that indicate following the medical recommendation
|
1 month
|
|
number of dives carried out since the consultation
Time Frame: 1 month
|
average number per year of practice
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne HENCKES, CHRU Brest
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29BRC21.0226 - Healthy diving
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Diving Barotrauma
-
Centre Hospitalier Universitaire de NiceCompletedDecompression Sickness | Diving
-
University Hospital of SplitUniversity of MarylandCompletedDecompression Sickness | SCUBA DivingUnited States, Croatia
-
Göteborg UniversitySahlgrenska University Hospital, Sweden; KTH Royal Institute of Technology; Swedish...CompletedInflammation | Endothelial Dysfunction | Decompression Sickness | Diving Medicine | Hyperbaric | Central Nervous InjurySweden
-
Direction Centrale du Service de Santé des ArméesRecruiting
-
University of Maryland, BaltimoreCompletedBarotrauma;EarUnited States
-
Assiut UniversityUnknown
-
University of PittsburghNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedMiddle-ear BarotraumaUnited States
-
Assiut UniversityNot yet recruitingMiddle Ear Barotrauma
-
Chang Gung Memorial HospitalRecruitingHyperbaric Oxygen Therapy | Middle Ear BarotraumaTaiwan
-
Northwell HealthRecruitingEar Diseases | Middle Ear Disease | Pressure Injury | Eustachian Tube Dysfunction | Ear Barotrauma | Middle Ear; Injury | Middle Ear BarotraumaUnited States