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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety, Nurse-Patient Relations, Behavior

Intervention / Treatment
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* Other: Guide of hosting


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Valuation instruments were two validated scales: ESAS y HADS. Experimental nursing instrument: Guide of hosting. | Other: Guide of hosting<br>* Guide of hosting with information about hospitalization to decrease anxiety<br>|
| No Intervention: Control<br>Valuation instruments were two validated scales: ESAS y HADS. Without Guide of hosting. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4-5 months | 
| 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). | 4-5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 4-5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, Urogical, Guide of Hosting, Comunication instrument, Patients