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Relatives Visit Prior to Hospital Admission & Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT03605420
Recruitment Status : Active, not recruiting
First Posted : July 30, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
César Calvo Lobo, Universidad de León

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Depression Care Unit Syndrome Other: Family visit prior to hospital admission Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effects of the Visit Prior to Hospital Admission on Anxiety, Depression and Satisfaction of Family in an Intensive Care Unit
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : December 16, 2018
Estimated Study Completion Date : December 20, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Family of a patient for hospital admission for surgery

Exclusion Criteria:

  • Cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03605420


Locations
Spain
Hospital La Princesa
Madrid, Spain, 28006
Sponsors and Collaborators
Universidad de León

Responsible Party: César Calvo Lobo, PhD, MSc, PT, Universidad de León
ClinicalTrials.gov Identifier: NCT03605420     History of Changes
Other Study ID Numbers: ICU-visit-relatives
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders