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Clinical Trials/NCT03977376
NCT03977376
Completed
Not Applicable

Effectiveness of a Prequirurgic Instrument to Decrease Anxiety in Urogical Quirurgic Patients: a Randomized Clinical Trial

University of Alcala1 site in 1 country50 target enrollmentJanuary 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
University of Alcala
Enrollment
50
Locations
1
Primary Endpoint
Anxiety: Hospital Anxiety and Depression Scale (HADS)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2019
End Date
May 26, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Alcala
Responsible Party
Principal Investigator
Principal Investigator

Carmen Gracia Ruiz García

Máster Social-sanitary Science Investigation

University of Alcala

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.

Outcomes

Primary Outcomes

Anxiety: Hospital Anxiety and Depression Scale (HADS)

Time Frame: 4-5 months

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)

Time Frame: 4-5 months

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 Outcomes

  • Pain: Edmonton Symptom Assessment System (ESAS)(4-5 months)

Study Sites (1)

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