PsychologyNCT06347289
Refusal of Organ Donation: a Study of Psychological, Anthropological and Cultural Factors
An observational study of Psychology and Anthropology, run by Centre Hospitalier de Saint-Denis at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychology, Anthropology, Refusal, Organ Donation
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 29 Mar 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: People and patients who visited Delafontaine's hospital.
Who may be able to join
- Agree to participate in the survey
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hopitalier de Saint-Denis
Saint-Denis, Seine Saint Denis, 93200
About this study
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.
Read the detailed 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
- 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.)
- 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
- 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
- Conditions
- Psychology, Anthropology, Refusal, Organ Donation
- Keywords
- refusal, organ donation, corpse, psychology, anthropology
- Medical subject headings
- Treatment Refusal, Cadaver
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic information
Sex
Measured: [day 1]
Demographic information
Age
Measured: [day 1]
Demographic information
Nationality
Measured: [day 1]
Demographic information
Mother tongue
Measured: [day 1]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Jan 2022
- Primary completion30 Apr 2023
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychologyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Collaborators
- Agence de La Biomédecine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347289
- Sponsor's protocol ID
- CHSD_0024_REA
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refusal of Organ Donation: a Study of Psychological, Anthropological and Cultural Factors
- ClinicalTrials.gov ID
- NCT06347289
- Acronym / sponsor ID
- CHSD_0024_REA
- Conditions
- Psychology, Anthropology, Refusal, Organ Donation
- Keywords
- refusal, organ donation, corpse, psychology, anthropology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Collaborators
- Agence de La Biomédecine
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 4 Apr 2024 (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.
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.
Detailed 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
- 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.)
- 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
- 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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People and patients who visited Delafontaine's hospital.
Key inclusion criteria (1 listed)
- Agree to participate in the survey
Key exclusion criteria (1 listed)
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic information
Time frame: [day 1]
Sex
Demographic information
Time frame: [day 1]
Age
Demographic information
Time frame: [day 1]
Nationality
Demographic information
Time frame: [day 1]
Mother tongue
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 4 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychology and Anthropology, run by Centre Hospitalier de Saint-Denis at 1 site in France.
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 1 inclusion and 1 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 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Demographic information (time frame: [day 1]). The study lists 4 primary outcomes in all. 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 4 Apr 2024.