Stress Disorders, Post-Traumatic Clinical Trial
Official title:
Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors: Comparison With the Nearest-relatives of Brain-dead Patients Who Were Not Organ Donors for Medical or Legal Reasons, or Because of Donation Opposition
Verified date | January 2018 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal is to compare post tramautic stress between the nearest relatives of brain-dead patients who are organ donor to those of brain-dead patients who are not organ donors for medical, legal or opposition reasons.
Status | Terminated |
Enrollment | 91 |
Est. completion date | May 15, 2016 |
Est. primary completion date | May 15, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - must be one of the following: person-of-trust previously designated by the deceased, a spouse, sibling, parent, or child of the deceased Exclusion Criteria: - refusal to participate - does not speak French - deaf/mute - adult, but under guardianship |
Country | Name | City | State |
---|---|---|---|
France | CH Henry Duffaut | Avignon | |
France | Centre Hospitalier Général | Beziers | |
France | Hôpital Guy de Chauliac, CHU de Montpellier | Montpellier Cedex 05 | |
France | Centre Hospitalier Universitaire de Nîmes | Nimes |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of participants with an IES score > 37 | The IES score follows Azoulay et al (2005). Am J Respir Crit Care Med. 171: 987-94. IES = Impact of Event Scale - revised, ranging from 0 to 88, with 88 being the greatest risk for post-traumatic stress | 2 hours | |
Secondary | The IES score | The Impact of Event Scale - revised, ranging from 0 to 88 | 2 hours | |
Secondary | Hospital Depression and Anxiety Score (HDAS) | score ranging from 0 (no symptoms) to 21 (max). HDAS scores >=8 indicate clinically significant depression or axiety | 2 hours |
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