Urologic DiseasesNCT05522686
The Effect of Different Education Methods Before Invasive Urodynamics
A study testing Patients in the Brochure Education Group, Patients in the Video Education Group and Patients in the Brochure-Supported Video Education Group in people with Urologic Diseases and Urodynamics, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Urologic Diseases, Urodynamics
- What is being tested?
- Patients in the Brochure Education Group, Patients in the Video Education Group and Patients in the Brochure-Supported Video Education Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older than 18 years of age,
- Had urodynamics for the first time,
- Had no communication problems,
- Volunteered to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Urologic Diseases, Urodynamics
- Being tested
- Patients in the Brochure Education Group, Patients in the Video Education Group, Patients in the Brochure-Supported Video Education Group, Control Group
- Keywords
- pain, anxiety, satisfaction, readiness, patient education, nursing, urodynamics
- Medical subject headings
- Urologic Diseases, Pain, Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients in the Brochure Education GroupOther
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 Video Education GroupOther
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 Brochure-Supported Video Education GroupOther
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.
Control GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: immediately after urodynamics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Aug 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Clinical Trial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Özden, Saglik Bilimleri Universitesi
- Investigators
- esra özden, Study chair, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522686
- Sponsor's protocol ID
- Invasive Urodynamics
- Status last verified
- Aug 2022
- First submitted
- 11 Jun 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05522686
- Acronym / sponsor ID
- Invasive Urodynamics
- Conditions
- Urologic Diseases, Urodynamics
- Keywords
- pain, anxiety, satisfaction, readiness, patient education, nursing, urodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Patients in the Brochure Education Group | Experimental | Other: Patients in the Brochure Education GroupPatients 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 Video Education Group | Experimental | Other: Patients in the Video Education GroupPatients 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 Brochure-Supported Video Education Group | Experimental | Other: Patients in the Brochure-Supported Video Education GroupPatients 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. |
| Control Group | Other | Other: Control GroupPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 18 years of age,
- Had urodynamics for the first time,
- Had no communication problems,
- Volunteered to participate in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients in the Brochure Education GroupPatients 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 GroupPatients 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 GroupPatients 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 GroupPatients 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 |
Primary outcome
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).
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
esra özden study chair
Gulhane Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients in the Brochure Education Group, Patients in the Video Education Group and Patients in the Brochure-Supported Video Education Group in people with Urologic Diseases and Urodynamics, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Anxiety (time frame: baseline (before education), pre-urodynamics and immediately after urodynamics). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.