跳至主要内容
临床试验/NCT05522686
NCT05522686已完成不适用

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

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Satisfaction management

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Patients in the Brochure Education Group (Other)

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.

干预措施: Patients in the Video Education Group (Other)

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.

干预措施: Patients in the Brochure-Supported Video Education Group (Other)

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.

干预措施: Control Group (Other)

结局指标

主要结局

Satisfaction management

时间窗: 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.

Change from Pain

时间窗: 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.

Change from Anxiety

时间窗: 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).

Change from Readiness for the Procedure

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra Özden

Principal Investigator and Lecturer

Saglik Bilimleri Universitesi

研究点 (1)

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