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

Not Applicable

Completed

• Conditions: Nurse-Patient Relations; Behavior; Anxiety
• Interventions: Other: Guide of hosting

• Registration Number: NCT03977376
• Lead Sponsor: University of Alcala

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.

Study Timeline

• Study Start: 2019-01-03
• Primary Completion: 2019-04-30
• Study Completion: 2019-05-26
• Status Verified: 2019-06
• Study First Submitted: 2019-06-02
• Study First Submitted QC: 2019-06-04
• Last Update Submitted: 2019-06-04
• Study First Posted: 2019-06-06
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Guide of hosting	Valuation instruments were two validated scales: ESAS y HADS. Experimental nursing instrument: Guide of hosting.

Primary Outcome Measures

Name	Time	Method
Anxiety: Hospital Anxiety and Depression Scale (HADS)	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)	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 Outcome Measures

Name	Time	Method
Pain: Edmonton Symptom Assessment System (ESAS)	4-5 months	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).

Trial Locations

Locations (1)

EPECA; 🇪🇸 Guadalajara, Spain