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GASA-CIR Trail (Guidance and the Symptoms of Acute Stress and Anxiety in Critically Ill Patients Relatives in Intensive Care Unit)

NCT03812458 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2020-01-13

No results posted yet for this study

Summary

A randomized clinical trial 1:1 among relatives of patients admitted to an intensive care unit, the intervention group will be composed by family members who receive a printed brochure and will be encouraged to visit a website detailed information and plain language about the ICU environment and the critically ill patient characteristics. The primary outcome will be the impact of orientations on symptoms of post-traumatic stress, assessed by the IES-R scale. Secondary outcome measures will include symptoms of anxiety and depression at the end of 7 days and after 3 months of follow-up by the HADS scales, the degree of satisfaction of the relatives, through the FS-ICU scale, as well as the association of resilience, through the CD-RISC scale, with the symptoms of anxiety and depression.

Conditions

Interventions

BEHAVIORAL

website and brochure

website and brochure

Sponsors & Collaborators

  • Hospital Moinhos de Vento

    collaborator OTHER

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • Federal University of Rio Grande do Sul

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-10
Primary Completion
2020-03-02
Completion
2020-12-10

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03812458 on ClinicalTrials.gov