The Effect of Different Education Methods Before Invasive Urodynamics

NCT05522686 | Completed

• 1 other identifier: Invasive Urodynamics
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urologic Diseases; Urodynamics

Keywords

pain; anxiety; satisfaction; readiness; patient education; nursing; urodynamics

Outcome Measures

Primary Outcomes (4)

• Change from Anxiety

  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

  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

  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

  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

Study Arms (4)

Patients in the Brochure Education Group

EXPERIMENTAL

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 Video Education Group

EXPERIMENTAL

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 Brochure-Supported Video Education Group

EXPERIMENTAL

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

Control Group

OTHER

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

Interventions

Patients in the Brochure Education Group OTHER

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.

Patients in the Brochure Education Group

Patients in the Video Education Group OTHER

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.

Patients in the Video Education Group

Patients in the Brochure-Supported Video Education Group OTHER

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.

Patients in the Brochure-Supported Video Education Group

Control Group OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Esra Özden

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urologic Diseases; Pain; Anxiety Disorders; Personal Satisfaction

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• esra özden

  Gulhane Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Lecturer

Model Details: Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: June 11, 2022
• First Posted: August 31, 2022
• Study Start: August 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

TU (1)