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

Anxiety Clinical Trial

— EPECA30-2018  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03977376
• Other study ID #: EPECA30-2018
• Status: Completed
• Phase: N/A
• Start date: January 3, 2019
• Est. completion date: May 26, 2019

Study information

• Verified date: June 2019
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 26, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Behavior
• Nurse-Patient Relations

Intervention

Other:
• Guide of hosting
Guide of hosting with information about hospitalization to decrease anxiety

Locations

Country	Name	City	State
Spain	EPECA	Guadalajara

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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