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Clinical Trials/NCT01589575
NCT01589575
Completed
Not Applicable

Evaluation of the Impact of Symptoms of Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives

Centre Hospitalier Universitaire de Nīmes1 site in 1 country208 target enrollmentSeptember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Disorders, Post-Traumatic
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
208
Locations
1
Primary Endpoint
Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The main objective of this study is to compare the rate of reported anxiety / depression (HADS >= 8) among spouses and other family members in ICU patients.

Detailed Description

The secondary objectives of this study are: * to assess symptoms of anxiety (HADS ≥ 8) and depression (HADS ≥ 8) among relatives of ICU patients three months after discharge * to assess what relatives felt vis-à-vis the information process * describe the number and duration of interviews with participants * to compare variables between the groups "spouses" and "other relatives". * satisfaction * number and duration of interviews * HADS questionnaire * The scale Edmunton * an internal questionnaire * IES-R score * level of mental well-being: WEMWBS * to describe the completeness of the study * to test the hypothesis that the development of symptoms related to physical manifestations of anxiety and depression predicts the development of post-traumatic stress at 3 months. * to assess the impact of the various forms of stress during hospitalization.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
January 2015
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The relative must have given his/her informed and signed consent
  • The relative must be insured or beneficiary of a health insurance plan
  • The relative must be available for 3 months of follow-up

Exclusion Criteria

  • The relative is under judicial protection, under tutorship or curatorship
  • The relative refuses to sign the consent
  • It is impossible to correctly inform the relative

Outcomes

Primary Outcomes

Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire

Time Frame: 3 months after the patients is discharged from the ICU unit

Secondary Outcomes

  • Number of interviews(During the ICU stay (days 1 to 28))
  • Mean interview duration (minutes)(During the ICU stay (days 1 to 28))
  • Edmonton Symptom Assessment Scale Score(4-6 days after the admission of a patient to the ICU)
  • The Impact of Event Scale - Revised (IES-R)(3 months after the patients is discharged from the ICU unit)
  • The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)(3 months after the patients is discharged from the ICU unit)
  • * Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire(4-6 days after the admission of a patient to the ICU)
  • VAS score for satisfaction concerning the communication of information concerning the patient currently in the ICU(During the ICU stay (days 1 to 28))

Study Sites (1)

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