Back to resultsEffectiveness of a Prequirurgic Instrument to Decrease Anxiety in Urogical Quirurgic Patients: a Randomized Clinical Trial (EPECA30-2018)
Primary Purpose
Anxiety, Nurse-Patient Relations, Behavior
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Guide of hosting
Sponsored by
About this trial
This is an interventional health services research trial for Anxiety focused on measuring anxiety, Urogical, Guide of Hosting, Comunication instrument, Patients
Eligibility Criteria
Inclusion Criteria:
- Age limits: 18 years old.
- with hospital admission scheduled at 5ªA hospitalization service of the University Hospital of Guadalajara for surgical intervention with urological diagnosis
Exclusion Criteria:
- patients with cognitive deficit.
- patients with recurrent insomnia problems
- without Spanish language proficiency
- patients that have participated in a clinical trial in the last three months.
Sites / Locations
- EPECA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Valuation instruments were two validated scales: ESAS y HADS. Experimental nursing instrument: Guide of hosting.
Valuation instruments were two validated scales: ESAS y HADS. Without Guide of hosting.
Outcomes
Primary Outcome Measures
Anxiety: Hospital Anxiety and Depression Scale (HADS)
To assess anxiety and depressive symptoms in a general medical population. There are 7 depression items measuring cognitive and emotional aspects of depression, predominantly anhedonia, intermingled with 7 anxiety items that focus on cognitive and emotional aspects of anxiety. Somatic items relating to emotional and physical disorders are excluded.
With 14 items.
Anxiety: Edmonton Symptom Assessment System (ESAS)
Value scale ESAS is a widely used, self-report symptom intensity tool for assessing nine common symptoms in hospilatation, with ratings ranging from 0 (none, best) to 10 (worst).
Secondary Outcome Measures
Pain: Edmonton Symptom Assessment System (ESAS)
Value scale ESAS is a widely used, self-report symptom intensity tool for assessing nine common symptoms in hospitalitation, with ratings ranging from 0 (none, best) to 10 (worst).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03977376
Brief Title
Effectiveness of a Prequirurgic Instrument to Decrease Anxiety in Urogical Quirurgic Patients: a Randomized Clinical Trial
Acronym
EPECA30-2018
Official Title
Effectiveness of a Prequirurgic Instrument to Decrease Anxiety in Urogical Quirurgic Patients: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
May 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The overall aim of this program of research is to decrease anxiety in urogical scheduled patients for surgical intervention developing an nursing comunication instrument: a Guide of Hosting for urogical scheduled patients for surgical intervention.
Detailed Description
The overall aim of this program of research is to decrease anxiety in urogical scheduled patients for surgical intervention developing an nursing communication instrument: a Guide of Hosting for urological scheduled patients for surgical intervention.
The purpose of the proposed project is to establish the feasibility and acceptability of this guide to decrease the anxiety in this patients, using a randomized clinical trial like a research design, which would test the effectiveness of this communication instrument in comparation to a control condition (patients without guide of housting).
To achieve the investigators specific aims, the investigator conducted a randomized clinical trial (n=50), with two groups: intervention group (with Guide of Hosting) and control group (which shows a control condition).
Valuation instruments were two validated scales: ESAS y HADS. Anxiety was the primary outcome variable assessed in the RCT; depression and pain were a secondary outcomes variables.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Nurse-Patient Relations, Behavior
Keywords
anxiety, Urogical, Guide of Hosting, Comunication instrument, Patients
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
RCT
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Valuation instruments were two validated scales: ESAS y HADS. Experimental nursing instrument: Guide of hosting.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Valuation instruments were two validated scales: ESAS y HADS. Without Guide of hosting.
Intervention Type
Other
Intervention Name(s)
Guide of hosting
Intervention Description
Guide of hosting with information about hospitalization to decrease anxiety
Primary Outcome Measure Information:
Title
Anxiety: Hospital Anxiety and Depression Scale (HADS)
Description
To assess anxiety and depressive symptoms in a general medical population. There are 7 depression items measuring cognitive and emotional aspects of depression, predominantly anhedonia, intermingled with 7 anxiety items that focus on cognitive and emotional aspects of anxiety. Somatic items relating to emotional and physical disorders are excluded.
With 14 items.
Time Frame
4-5 months
Title
Anxiety: Edmonton Symptom Assessment System (ESAS)
Description
Value scale ESAS is a widely used, self-report symptom intensity tool for assessing nine common symptoms in hospilatation, with ratings ranging from 0 (none, best) to 10 (worst).
Time Frame
4-5 months
Secondary Outcome Measure Information:
Title
Pain: Edmonton Symptom Assessment System (ESAS)
Description
Value scale ESAS is a widely used, self-report symptom intensity tool for assessing nine common symptoms in hospitalitation, with ratings ranging from 0 (none, best) to 10 (worst).
Time Frame
4-5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age limits: 18 years old.
with hospital admission scheduled at 5ªA hospitalization service of the University Hospital of Guadalajara for surgical intervention with urological diagnosis
Exclusion Criteria:
patients with cognitive deficit.
patients with recurrent insomnia problems
without Spanish language proficiency
patients that have participated in a clinical trial in the last three months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gracia Ruiz Garcia
Organizational Affiliation
Máster Universitario en Investigación en Ciencias Sociosanitarias - UAH
Official's Role
Principal Investigator
Facility Information:
Facility Name
EPECA
City
Guadalajara
ZIP/Postal Code
19005
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of a Prequirurgic Instrument to Decrease Anxiety in Urogical Quirurgic Patients: a Randomized Clinical Trial
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