Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors
- Conditions
- Stress Disorders, Post-TraumaticTissue DonorsTissue and Organ Procurement
- Registration Number
- NCT01214018
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 91
- must be one of the following: person-of-trust previously designated by the deceased, a spouse, sibling, parent, or child of the deceased
- refusal to participate
- does not speak French
- deaf/mute
- adult, but under guardianship
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants with an IES score > 37 2 hours 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
- Secondary Outcome Measures
Name Time Method The IES score 2 hours The Impact of Event Scale - revised, ranging from 0 to 88
Hospital Depression and Anxiety Score (HDAS) 2 hours score ranging from 0 (no symptoms) to 21 (max). HDAS scores \>=8 indicate clinically significant depression or axiety
Trial Locations
- Locations (4)
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, France
CH Henry Duffaut🇫🇷Avignon, France