- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03605407
Patients 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 Patients in an Intensive Care Unit
The present study evaluates the effects of the visit prior to hospital admission on anxiety, depression and satisfaction of patients 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
-
-
-
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:
- Patient at 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
Patient receiving one visit prior to hospital admission
|
Patient and family receiving one visit prior to hospital admission for surgery
|
|
No Intervention: Control group
Patient without receiving one visit prior to hospital admission
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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-patients
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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