Back to resultsRelatives Visit Prior to Hospital Admission & Intensive Care Unit
Primary Purpose
Anxiety, Depression, Care Unit Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Family visit prior to hospital admission
Sponsored by
About this trial
This is an interventional health services research trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- Family of a patient for hospital admission for surgery
Exclusion Criteria:
- Cognitive impairment
Sites / Locations
- Hospital La Princesa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
Receiving one family visit prior to hospital admission
Without receiving one family visit prior to hospital admission
Outcomes
Primary Outcome Measures
The Hospital Anxiety and Depression Scale
Anxiety subscale range from 0 to 21. Depression subscale range from 0 to 21. Higher values represent a worse outcome (higher depression or anxiety).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03605420
Brief Title
Relatives Visit Prior to Hospital Admission & Intensive Care Unit
Official Title
Effects of the Visit Prior to Hospital Admission on Anxiety, Depression and Satisfaction of Family in an Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 22, 2018 (Actual)
Primary Completion Date
January 20, 2019 (Actual)
Study Completion Date
January 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de León
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Care Unit Syndrome
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Receiving one family visit prior to hospital admission
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Without receiving one family visit prior to hospital admission
Intervention Type
Other
Intervention Name(s)
Family visit prior to hospital admission
Intervention Description
Family receiving one visit prior to hospital admission for surgery
Primary Outcome Measure Information:
Title
The Hospital Anxiety and Depression Scale
Description
Anxiety subscale range from 0 to 21. Depression subscale range from 0 to 21. Higher values represent a worse outcome (higher depression or anxiety).
Time Frame
Change from Baseline anxiety and depression at 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Family of a patient for hospital admission for surgery
Exclusion Criteria:
Cognitive impairment
Facility Information:
Facility Name
Hospital La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Relatives Visit Prior to Hospital Admission & Intensive Care Unit
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