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

NCT ID: NCT03977376

Last Updated: 2019-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-03

Study Completion Date

2019-05-26

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.

Conditions

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Anxiety Nurse-Patient Relations Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

RCT

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Guide of hosting

Intervention Type OTHER

Guide of hosting with information about hospitalization to decrease anxiety

Control

Valuation instruments were two validated scales: ESAS y HADS. Without Guide of hosting.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Guide of hosting

Guide of hosting with information about hospitalization to decrease anxiety

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alcala

OTHER

Sponsor Role lead

Responsible Party

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Carmen Gracia Ruiz García

Máster Social-sanitary Science Investigation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carmen Gracia Ruiz Garcia

Role: PRINCIPAL_INVESTIGATOR

Máster Universitario en Investigación en Ciencias Sociosanitarias - UAH

Locations

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EPECA

Guadalajara, , Spain

Site Status

Countries

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Spain

Other Identifiers

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EPECA30-2018

Identifier Type: -

Identifier Source: org_study_id

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