The Effect of Different Education Methods Before Invasive Urodynamics

August 28, 2022 updated by: Esra Özden, Saglik Bilimleri Universitesi

The Effect of Different Education Methods Before Invasive Urodynamics on Patients' Anxiety, Pain, Readiness for the Procedure, and Satisfaction Levels: A Randomized Controlled Clinical Trial

Aim: This study was carried out to compare the effects of different education methods utilized before a urodynamic testing procedure on patients' pain, anxiety, readiness for the procedure, and satisfaction.

Background: Urodynamic testing is an invasive procedure that causes pain and anxiety. Patient education is an evidence-based nursing intervention that relieves pain and anxiety and increases patient satisfaction.

Design: The study is a single-center, randomized controlled clinical trial. Method: Participants (n=80) were randomly assigned to four groups. While patients in the control group were provided with routine clinical information, patients in the intervention group were given education with brochures, videos, and brochure-supported videos. The research data were collected by using a Data Collection Form with items about participants' descriptive characteristics, the State Anxiety Inventory, and the Visual Analog Scale.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Esra Özden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Older than 18 years of age,
  • Had urodynamics for the first time,
  • Had no communication problems,
  • Volunteered to participate in the study

Exclusion Criteria:

  • Had major hearing, vision, and speech impairments,
  • Used antidepressants, or anxiolytic drugs,
  • Had an indwelling urinary catheter,
  • Used any analgesic in the 24 hours before coming to the urodynamic laboratory

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients in the Brochure Education Group
Patients in the Brochure Education Group were given information about urodynamics in a room reserved for education, and the education brochure was introduced. Patients reviewed the brochure and at the end of the education, it was given to them.
Other: Patients in the Brochure Education Group
Patients in the Brochure Education Group were given information about urodynamics in a room reserved for education, and the education brochure was introduced. Patients reviewed the brochure and at the end of the education, it was given to them.
Experimental: Patients in the Video Education Group
Patients in the Video Education Group were informed about urodynamics in a room reserved for education. Patients watched the educational video on a computer. The urodynamics patient education video was shown to patients once during the session. They did not request to watch it again.
Other: Patients in the Video Education Group
Patients in the Video Education Group were informed about urodynamics in a room reserved for education. Patients watched the educational video on a computer. The urodynamics patient education video was shown to patients once during the session. They did not request to watch it again.
Experimental: Patients in the Brochure-Supported Video Education Group
Patients in the Brochure-Supported Video Education Group were given information about urodynamics in a room reserved for education, and the education brochure was introduced. They examined the brochure and watched the educational video on a computer.
Other: Patients in the Brochure-Supported Video Education Group
Patients in the Brochure-Supported Video Education Group were given information about urodynamics in a room reserved for education, and the education brochure was introduced. They examined the brochure and watched the educational video on a computer.
Other: Control Group
Patients in this group were given routine clinical information by the healthcare professional that would perform the urodynamics procedure. After patients were given verbal information, a written text containing the necessary preparations for urodynamics was given to them. The routine patient information text included adjustment to the appointment day and time, nutrition, mechanical bowel preparation, and medications necessary for the procedure.
Other: Control Group
Patients in this group were given routine clinical information by the healthcare professional that would perform the urodynamics procedure. After patients were given verbal information, a written text containing the necessary preparations for urodynamics was given to them. The routine patient information text included adjustment to the appointment day and time, nutrition, mechanical bowel preparation, and medications necessary for the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Anxiety
Time Frame: baseline (before education), pre-urodynamics and immediately after urodynamics
This is a questionnaire consisting of short statements developed by C.D. Spielberger et al. in 1970. The inventory, which consists of 20 items in total, is used to determine how an individual feels at a certain time and under certain conditions. Scores that can be obtained on the scale range between 20 and 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety (Spielberger, 1983).
baseline (before education), pre-urodynamics and immediately after urodynamics
Change from Pain
Time Frame: baseline (before education), pre-urodynamics and immediately after urodynamics
This form, which has three sections, namely pre-education, post-education/pre-procedure, and post-procedure, includes the Visual Analogue Scale (VAS) and a recording table for some physiological parameters (blood pressure, pulse, respiration). The Visual Analogue Scale (VAS) is a valid, reliable, and usable measurement tool for repeated measurements. The VAS has been used in many studies to evaluate readiness for the urodynamic procedure, satisfaction, pain, procedure-related expectation of pain, and willingness to have the procedure again if necessary (Shim, 2017; Warda, 2019; Öztürk, 2019). In this study, readiness for the procedure, satisfaction, procedure-related expectation of pain, and willingness to have the procedure again if necessary, which are among parameters that are thought to affect the subsequent health behaviors of patients, were evaluated by using the VAS.
baseline (before education), pre-urodynamics and immediately after urodynamics
Change from Readiness for the Procedure
Time Frame: baseline(before education) and pre-urodynamics.
In this study, readiness for the procedure which are among parameters that are thought to affect the subsequent health behaviors of patients, were evaluated by using the VAS.
baseline(before education) and pre-urodynamics.
Satisfaction management
Time Frame: immediately after urodynamics
This form, which has three sections, namely pre-education, post-education/pre-procedure, and post-procedure, includes the Visual Analogue Scale (VAS) and a recording table for some physiological parameters (blood pressure, pulse, respiration). The Visual Analogue Scale (VAS) is a valid, reliable, and usable measurement tool for repeated measurements. The VAS has been used in many studies to evaluate readiness for the urodynamic procedure, satisfaction, pain, procedure-related expectation of pain, and willingness to have the procedure again if necessary (Shim, 2017; Warda, 2019; Öztürk, 2019). In this study, readiness for the procedure, satisfaction, procedure-related expectation of pain, and willingness to have the procedure again if necessary, which are among parameters that are thought to affect the subsequent health behaviors of patients, were evaluated by using the VAS.
immediately after urodynamics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Investigators

  • Study Chair: esra özden, Gulhane Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

June 11, 2022

First Submitted That Met QC Criteria

August 28, 2022

First Posted (Actual)

August 31, 2022

Study Record Updates

Last Update Posted (Actual)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 28, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Invasive Urodynamics

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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