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Completed

NCT Number: NCT03977376

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Mental Disorders Nurse-Patient Relations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EPECA

Guadalajara, 19005, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guide of hosting

Other

Guide of hosting with information about hospitalization to decrease anxiety

Primary outcomes

  1. 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.

  2. 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

  1. Pain: 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 hospitalitation, with ratings ranging from 0 (none, best) to 10 (worst).

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Acronym: EPECA30-2018

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 6, 2019
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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