Relatives Visit Prior to Hospital Admission & Intensive Care Unit

January 25, 2019 updated by: César Calvo Lobo, Universidad de León

Effects of the Visit Prior to Hospital Admission on Anxiety, Depression and Satisfaction of Family in an Intensive Care Unit

The present study evaluates the effects of the visit prior to hospital admission on anxiety, depression and satisfaction of family in an intensive care unit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28006
        • Hospital La Princesa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Family of a patient for hospital admission for surgery

Exclusion Criteria:

  • Cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Receiving one family visit prior to hospital admission
Other: Family visit prior to hospital admission
Family receiving one visit prior to hospital admission for surgery
No Intervention: Control group
Without receiving one family visit prior to hospital admission

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Hospital Anxiety and Depression Scale
Time Frame: Change from Baseline anxiety and depression at 90 days
Anxiety subscale range from 0 to 21. Depression subscale range from 0 to 21. Higher values represent a worse outcome (higher depression or anxiety).
Change from Baseline anxiety and depression at 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de León

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2018

Primary Completion (Actual)

January 20, 2019

Study Completion (Actual)

January 25, 2019

Study Registration Dates

First Submitted

July 21, 2018

First Submitted That Met QC Criteria

July 21, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Actual)

January 28, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICU-visit-relatives

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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