Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-01 @ 11:14 PM
Study NCT ID:
NCT06555666
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2021-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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)
Sponsor:
University Hospital, Brest
Organization:
Study Overview
Official Title:
Practice of Scuba Diving by as Many People as Possible: Effect of Medical Assessment to Provide a Suitable and Individualised Framework for Practice
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Healthy-diving
Brief Summary:
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").
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").
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: