Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors

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

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.

Study Overview

• Status: Terminated
• Conditions: Stress Disorders, Post-Traumatic; Tissue and Organ Procurement; Tissue Donors
• Intervention / Treatment: Other: Questionnaires and interview

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• France
  • Avignon, France, 84902
    • CH Henry Duffaut
  • Beziers, France, 34525
    • Centre Hospitalier General
  • Montpellier Cedex 05, France, 34295
    • Hôpital Guy de Chauliac, CHU de Montpellier
  • Nimes, France, 30029
    • Centre Hospitalier Universitaire de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study participants are the nearest relatives of brain-dead patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Reference; Nearest relatives of brain-dead patients who donated organs	Other: Questionnaires and interview; Questionnaires and interview
Opposition; Nearest relatives of brain-dead patients opposed to organ donation	Other: Questionnaires and interview; Questionnaires and interview
Medical/Legal; Nearest relatives of brain-dead patients for whom organ donation was not an option because of medical or legal reasons	Other: Questionnaires and interview; Questionnaires and interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The IES score	The Impact of Event Scale - revised, ranging from 0 to 88	2 hours
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2011
• Primary Completion (Actual): May 15, 2016
• Study Completion (Actual): May 15, 2016

Study Registration Dates

• First Submitted: October 1, 2010
• First Submitted That Met QC Criteria: October 1, 2010
• First Posted (Estimate): October 4, 2010

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 2, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Trauma and Stressor Related Disorders; Death; Unconsciousness; Consciousness Disorders; Coma; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Brain Death
• Other Study ID Numbers: LOCAL/2009/CB-04