Ureteral CalculiNCT06715202
Effect of Educatıon Gıven To Patıents Wıth Ureteral Stent (Dj) Insertıon On Postoperatıve Symptom Management And Qualıty of Lıfe
A study testing Patient Education Booklet in people with Ureteral Calculi, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The data of the randomized controlled experimental study were collected at the Urology Clinics of Atatürk University Health Practice and Research Hospital between April and November 2022. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ureteral Calculi
- What is being tested?
- Patient Education Booklet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 30 Nov 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65
- Volunteering to participate in the study
- Having URS surgery for the first time due to stones and temporary DJ stent placement
Who cannot join
- Having URS surgery for reasons other than stones
- Having a permanent stent
- Having major hearing and vision impairment
- Using antidepressants or anxiolytics
Trial locations and contacts
1 site in 1 country.
About this study
The data of the randomized controlled experimental study were collected at the Urology Clinics of Atatürk University Health Practice and Research Hospital between April and November 2022. The study sample consisted of 162 patients (82 in the training group, 80 in the control group) who were selected by simple random sampling method and met the inclusion criteria for the study.
Read the detailed description
Ureteral stents have been widely used in many urological procedures since their use was published by Zimskind in 1967 and Finley's use of the modern double J (DJ) stent in 1978. Ureterorenoscopy (URS) is a popular method used frequently in the diagnosis and treatment of ureteral diseases today. Apart from being performed for diagnostic purposes, URS is most commonly used to treat ureteral stones. The vast majority of ureteral stones are treated endoscopically. A Double-J (DJ) stent is often placed after ureterorenoscopy. The purpose of the stent is to prevent obstruction, renal colic, and deterioration of renal function. The fact that the DJ stent will remain in the patient for a certain period of time (approximately 3-4 weeks) causes anxiety in the patient. However, urinary system symptoms that impair the quality of life are observed in approximately 80% of patients who have a DJ stent. These symptoms include frequent urination (50-60%), urgency (57-60%), pain during urination (40%), incomplete voiding (76%), flank pain (19-32%), suprapubic pain (30%), incontinence and hematuria (25%). In addition, 32% of patients with DJ stents develop sexual dysfunction. 2,3,4 Patients who have DJ stents inserted after ureteroscopy surgery need more information, support, explanation and help to cope with the effects of these symptoms in the clinic and at home. 5 In this context, it is important to provide individualized and comprehensive education that includes the home care process before and after URS. It has been determined in the literature that education given before surgical intervention reduces anxiety, pain level, complication rate and depression rate in the postoperative period and increases patient satisfaction. 6,7,8 However, it is reported that individuals should be discharged with sufficient theory and practice to meet their post-discharge care needs. Although all healthcare personnel are responsible for the discharge education of individuals and their relatives, the most important responsibility belongs to nurses.
- Conditions
- Ureteral Calculi
- Being tested
- Patient Education Booklet
- Keywords
- Ureteral Stent (DJ), Symptom Management, Quality of Life
- Medical subject headings
- Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Education BookletProcedure or surgery
Before the surgery, a personal information form and the SF-36 Quality of Life Scale will be filled out. The educational content regarding the problems that these patients may encounter with the DJ stent after the surgery until they are discharged will be explained in sections and the patients' questions will be answered. When the patient comes to the hospital for DJ stent removal 4 weeks after discharge, the Ureteral Stent Symptom 1st Questionnaire and the SF-36 Quality of Life Scale will be filled out while the DJ stent is in place. The Ureteral Stent Symptom 2nd Questionnaire and the SF-36 Quality of Life Scale will be applied 4 weeks after the stent is removed. The education booklet will be prepared by the researchers in accordance with the recommendations of the European Association of Urology and the relevant literature.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Patient Education Booklet | Experimental | Patients will be informed about URS, DJ stents and possible problems in the early postoperative period with an education booklet and the patient's questions will be answered. Receives: Procedure: Patient Education Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Ureteral Stent Symptom Questionnaire: In 2003, Joshi and colleagues developed a special questionnaire for the assessment of quality of life and stent-related symptoms. The Ureteral Stent Symptoms Questionnaire (USSQ), a validated tool that assesses symptoms and quality of life, was validated in Turkish by Yılören and colleagues in 2017. The USSQ was originally designed as a 38-item questionnaire with 33 Likert-type questions and 5 more descriptive items organized into six main areas. This questionnaire provides a comprehensive assessment of urinary symptoms, general health, pain, sexual health, work performance, and other additional problems related to ureteral stents
Measured: The universe of the study, between April and November 2022.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Apr 2022
- Primary completion30 Aug 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral CalculiStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muazzez Merve TORAMAN, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715202
- Sponsor's protocol ID
- Muazzez Merve TORAMAN
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Educatıon Gıven To Patıents Wıth Ureteral Stent (Dj) Insertıon On Postoperatıve Symptom Management And Qualıty of Lıfe
- ClinicalTrials.gov ID
- NCT06715202
- Acronym / sponsor ID
- Muazzez Merve TORAMAN
- Conditions
- Ureteral Calculi
- Keywords
- Ureteral Stent (DJ), Symptom Management, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 4 Dec 2024 (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.
The data of the randomized controlled experimental study were collected at the Urology Clinics of Atatürk University Health Practice and Research Hospital between April and November 2022. The study sample consisted of 162 patients (82 in the training group, 80 in the control group) who were selected by simple random sampling method and met the inclusion criteria for the study.
Detailed description
Ureteral stents have been widely used in many urological procedures since their use was published by Zimskind in 1967 and Finley's use of the modern double J (DJ) stent in 1978. Ureterorenoscopy (URS) is a popular method used frequently in the diagnosis and treatment of ureteral diseases today. Apart from being performed for diagnostic purposes, URS is most commonly used to treat ureteral stones. The vast majority of ureteral stones are treated endoscopically. A Double-J (DJ) stent is often placed after ureterorenoscopy. The purpose of the stent is to prevent obstruction, renal colic, and deterioration of renal function. The fact that the DJ stent will remain in the patient for a certain period of time (approximately 3-4 weeks) causes anxiety in the patient. However, urinary system symptoms that impair the quality of life are observed in approximately 80% of patients who have a DJ stent. These symptoms include frequent urination (50-60%), urgency (57-60%), pain during urination (40%), incomplete voiding (76%), flank pain (19-32%), suprapubic pain (30%), incontinence and hematuria (25%). In addition, 32% of patients with DJ stents develop sexual dysfunction. 2,3,4 Patients who have DJ stents inserted after ureteroscopy surgery need more information, support, explanation and help to cope with the effects of these symptoms in the clinic and at home. 5 In this context, it is important to provide individualized and comprehensive education that includes the home care process before and after URS. It has been determined in the literature that education given before surgical intervention reduces anxiety, pain level, complication rate and depression rate in the postoperative period and increases patient satisfaction. 6,7,8 However, it is reported that individuals should be discharged with sufficient theory and practice to meet their post-discharge care needs. Although all healthcare personnel are responsible for the discharge education of individuals and their relatives, the most important responsibility belongs to nurses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Patient Education Booklet | Experimental | Procedure: Patient Education BookletPatients will be informed about URS, DJ stents and possible problems in the early postoperative period with an education booklet and the patient's questions will be answered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-65
- Volunteering to participate in the study
- Having URS surgery for the first time due to stones and temporary DJ stent placement
Key exclusion criteria (4 listed)
- Having URS surgery for reasons other than stones
- Having a permanent stent
- Having major hearing and vision impairment
- Using antidepressants or anxiolytics
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 |
|---|---|---|
| Patient Education BookletBefore the surgery, a personal information form and the SF-36 Quality of Life Scale will be filled out. The educational content regarding the problems that these patients may encounter with the DJ stent after the surgery until they are discharged will be explained in sections and the patients' questions will be answered. When the patient comes to the hospital for DJ stent removal 4 weeks after discharge, the Ureteral Stent Symptom 1st Questionnaire and the SF-36 Quality of Life Scale will be filled out while the DJ stent is in place. The Ureteral Stent Symptom 2nd Questionnaire and the SF-36 Quality of Life Scale will be applied 4 weeks after the stent is removed. The education booklet will be prepared by the researchers in accordance with the recommendations of the European Association of Urology and the relevant literature. | Procedure or surgery | Experimental: Patient Education Booklet |
Primary outcome
Primary Outcome Measure
Time frame: The universe of the study, between April and November 2022.
Ureteral Stent Symptom Questionnaire: In 2003, Joshi and colleagues developed a special questionnaire for the assessment of quality of life and stent-related symptoms. The Ureteral Stent Symptoms Questionnaire (USSQ), a validated tool that assesses symptoms and quality of life, was validated in Turkish by Yılören and colleagues in 2017. The USSQ was originally designed as a 38-item questionnaire with 33 Likert-type questions and 5 more descriptive items organized into six main areas. This questionnaire provides a comprehensive assessment of urinary symptoms, general health, pain, sexual health, work performance, and other additional problems related to ureteral stents
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 4 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education Booklet in people with Ureteral Calculi, run by Ataturk University 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 3 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 4 Dec 2024. 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?
Primary Outcome Measure (time frame: The universe of the study, between April and November 2022.). 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 4 Dec 2024.