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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06347289
Other study ID # CHSD_0024_REA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date March 29, 2024

Study information

Verified date March 2024
Source Centre Hospitalier de Saint-Denis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Hospital of Saint Denis (HSD) has been involved for several years in the dynamics of organ donation. In spite of the evolution of the practices of coordination of the collection of samples, the rate of refusal of organ donation is increasing in our hospital, contrary to the rest of France. Based on hypotheses derived from psychological and anthropological perspectives, this survey will provide first-hand information on the personal, family and cultural issues related to organ donation. It will be a question of identifying and locating individual and collective representations concerning death, its definition, and the associated symbols and rites. Based on the collection of these representations, we will be able to propose hypotheses of a psychological, social and anthropological nature on resistance to organ donation.


Description:

The Hospital of Saint Denis (HSD) has been involved for several years in the dynamics of organ donation. In spite of the evolution of the practices of coordination of the collection of samples, the rate of refusal of organ donation is increasing in our hospital, contrary to the rest of France. Based on hypotheses derived from psychological and anthropological perspectives, this survey will provide first-hand information on the personal, family and cultural issues related to organ donation. It will be a question of identifying and locating individual and collective representations concerning death, its definition, and the associated symbols and rites. Based on the collection of these representations, we will be able to propose hypotheses of a psychological, social and anthropological nature on resistance to organ donation. Methodology : Mixed quantitative and qualitative study 1. Questionnaire: The collection will be carried out prospectively on the hospital site for a period of 12 months. At the rate of one day per week. We estimate that we will be able to include 100 subjects during this period. Only those who have completed all the questionnaires will be included in the study. The collection will focus on the characteristics of the respondent (sex, age etc...) and will consist of 4 fields of questioning with open and closed questions (Biological and symbolic functioning associated with the organs that may be harvested, representation of death, fate of the corpse, and philosophical and religious positions regarding death and the corpse. Questions also on representations of the relationship between the hospital institution and the dead body: autopsy, brain death, organ removal, etc.) 2. Participant observation: by social science researcher. Targeted participation at key moments of the process leading to organ harvesting (medical staff in resuscitation, announcement interview, collection of non-opposition) allowing to carry out an ethnography. Duration: 3 months 3. Semi-structured interviews: at the end of the observation, concerning the various hospital actors in the organ donation process, both at the resuscitation level and the coordination of organ retrieval and the various professions (doctors, nurses, nursing auxiliaries). Number of interviews: 20


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 29, 2024
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Agree to participate in the survey Exclusion Criteria: - Refusal to participate

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre Hopitalier de Saint-Denis Saint-Denis Seine Saint Denis

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier de Saint-Denis Agence de La Biomédecine

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Demographic information Sex [day 1]
Primary Demographic information Age [day 1]
Primary Demographic information Nationality [day 1]
Primary Demographic information Mother tongue [day 1]
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