Kidney CalculiNCT05511545
The Effect of Education Given to Patients on Pre- and Post-operative Anxiety and Preparation for Discharge
A study testing Patient Education Booklet in people with Kidney Calculi, run by Ataturk University at 2 sites in Turkey (Türkiye).
Trial summary
The data of the randomized controlled experimental research were collected at Atatürk University Health Application and Research Hospital Urology Clinics between November 2021 and May 2022. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Calculi
- What is being tested?
- Patient Education Booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 3 Nov 2021to 1 Jul 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
- Agreeing to participate in the research and volunteering,
- Those between the ages of 18-65,
- Having URS surgery for the first time due to stone and temporary DJ stent placed,
- Patients whose cognitive level scales were suitable for application were included in the study.
Who cannot join
- Having URS surgery for non-stone causes,
- Permanent stent placed,
- Leaving work voluntarily,
- Patients with major hearing and vision problems were not included in the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Muazzez Merve TORAMAN
Erzurum, Palandöken, 25000
Muazzez Merve TORAMAN
Erzurum, 2500
About this study
Official title: The Effect of Training Given to Patients Who Underwent Ureteroscopy With Double-J Stent Placement on Anxiety Before and After Surgery and Readiness for Discharge
The data of the randomized controlled experimental research were collected at Atatürk University Health Application and Research Hospital Urology Clinics between November 2021 and May 2022. The study sample consisted of 122 patients (61 in the training group, 61 in the control group) who were selected by the simple random sampling method and met the research inclusion criteria.
Read the detailed description
Ureteroscopy (URS) is an up-to-date method that is widely used in the diagnosis and treatment of ureteral diseases. Apart from the diagnostic purposes of URS, the most common use is to intervene in ureteral stones. The vast majority of ureteral stones are treated endoscopically. A Double-J (DJ) stent is often placed after ureteroscopy. 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, approximately 80% of patients with DJ stent implantation have urinary system symptoms that impair their quality of life. Frequent urination (50-60%), sudden urge to urinate (57-60%), pain on urination (40%), incomplete evacuation (76%), flank pain (19-32%), suprapubic pain (30%) , incontinence and hematuria (25%) are the symptoms seen. Patients with DJ stent implanted after ureteroscopy surgery need more information, support, explanation and help to cope with the effects of these symptoms in the clinic and at home. In this context, it is important to provide an individualized and comprehensive education that includes the home care process before and after the URS. It has been determined in the literature that training before surgery reduces anxiety, pain level, complication and depression rates, and increases patient satisfaction in the postoperative period. No study has been found in the literature examining the effects of education given to patients with URS on their post-operative anxiety and readiness for discharge. In this context, this study will provide evidence-based data to the literature by investigating the effects of training given to patients with URS and DJ stent implantation on pre- and postoperative anxiety and readiness for discharge.
- Conditions
- Kidney Calculi
- Being tested
- Patient Education Booklet
- Keywords
- anxiety, double j stent, nurse, education, ureteroscopy
- Medical subject headings
- Kidney Calculi, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Education BookletOther
Excretory system organs, signs and symptoms to be seen in kidney and ureteral stones, treatment methods, ureteroscopy procedure, what to do before and on the morning of surgery, and surgery, using the training booklet prepared by the researchers in line with the recommendations of the European Association of Urology and the relevant literature. An average of 25-30 minutes of training was given in the patient's room in an encouraging language, allowing the patient to ask questions about the situations he would encounter in the clinic after the surgery. She started asking questions she didn't understand. Afterwards, the questions of the patients were answered and the patient was given a training booklet.
| Study group | Role | What they receive |
|---|---|---|
| Patient Education Booklet | Experimental | One day before surgery:
The patients in the training group were informed about the study one day before the operation and their verbal and written consents were obtained. Afterwards, the Descriptive Information Form, the State-Trait Anxiety Inventory, and the Surgery-Specific Anxiety Inventory were administered. A training booklet was prepared by the researchers in line with the recommendations of the European Association of Urology and the relevant literature. The training took an average of 25-30 minutes. Afterwards, the questions of the patients were answered and the training booklet was given to the patient.The scales were reapplied on the morning of the surgery.
Before discharge, the State Anxiety Scale and the Readiness to Discharge Scale-Patient Self-Assessment Form were administered. Then, the Adult Patient Discharge Readiness Scale-Nurse Evaluation Short Form was filled by the clinical nurse caring for the patient. Receives: Other: Patient Education Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety İnventory (STAI-I, STAI-II)
It is a test developed by Spielberger et al. that measures state and trait anxiety levels. Its validity and reliability in Turkey was done by Owner and Le Compte. The scale consists of two parts, the 'state anxiety scale', which is created with the aim of determining the instantaneous feelings, and the 20-item 'trait anxiety scale', which was created to determine the feelings in general. It is a four degree scale ranging from 'Nothing' to 'All'. Scores range from 20 (low anxiety) to 80 (high anxiety).
Measured: up to 24 hours
Surgery Specific Anxiety Scale
This scale was developed in Turkish by Karancı and Dirik in 2003 to measure the pre- and postoperative anxiety of surgical patients. It consists of 10 items in total. Each item is rated on a 5-point Likert-type scale. The surgery-specific anxiety score is obtained by summing the responses to all items. The minimum score that can be obtained from the scale is 10, and the maximum score is 50.
Measured: up to 24 hours
Readiness for Hospital Discharge Scale for Adult Patients-Short Form and Readiness for Hospital Discharge Scale- Adult-Nurse Assesment Short Form
The scale developed by Weiss et al. in 2006 was used by Kaya et al. It was adapted to Turkish in 2018 and has parallel questions with the nurse version, and has a 10-point Likert-type evaluation. The scale, in which the patients' readiness for discharge is evaluated by themselves, consists of eight items and four sub-dimensions. Eight questions in the scale are evaluated with scores between 0-10, from the lowest to the highest.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start3 Nov 2021
- Primary completion30 May 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muazzez Merve TORAMAN, Ataturk University
- Investigators
- Muazzez Merve TORAMAN, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511545
- Sponsor's protocol ID
- Muazzez
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 23 Aug 2022
- 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 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training Given to Patients Who Underwent Ureteroscopy With Double-J Stent Placement on Anxiety Before and After Surgery and Readiness for Discharge
- ClinicalTrials.gov ID
- NCT05511545
- Acronym / sponsor ID
- Muazzez
- Conditions
- Kidney Calculi
- Keywords
- anxiety, double j stent, nurse, education, ureteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 23 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.
The data of the randomized controlled experimental research were collected at Atatürk University Health Application and Research Hospital Urology Clinics between November 2021 and May 2022. The study sample consisted of 122 patients (61 in the training group, 61 in the control group) who were selected by the simple random sampling method and met the research inclusion criteria.
Detailed description
Ureteroscopy (URS) is an up-to-date method that is widely used in the diagnosis and treatment of ureteral diseases. Apart from the diagnostic purposes of URS, the most common use is to intervene in ureteral stones. The vast majority of ureteral stones are treated endoscopically. A Double-J (DJ) stent is often placed after ureteroscopy. 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, approximately 80% of patients with DJ stent implantation have urinary system symptoms that impair their quality of life. Frequent urination (50-60%), sudden urge to urinate (57-60%), pain on urination (40%), incomplete evacuation (76%), flank pain (19-32%), suprapubic pain (30%) , incontinence and hematuria (25%) are the symptoms seen. Patients with DJ stent implanted after ureteroscopy surgery need more information, support, explanation and help to cope with the effects of these symptoms in the clinic and at home. In this context, it is important to provide an individualized and comprehensive education that includes the home care process before and after the URS. It has been determined in the literature that training before surgery reduces anxiety, pain level, complication and depression rates, and increases patient satisfaction in the postoperative period. No study has been found in the literature examining the effects of education given to patients with URS on their post-operative anxiety and readiness for discharge. In this context, this study will provide evidence-based data to the literature by investigating the effects of training given to patients with URS and DJ stent implantation on pre- and postoperative anxiety and readiness for discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Education Booklet | Experimental | Other: Patient Education BookletOne day before surgery: The patients in the training group were informed about the study one day before the operation and their verbal and written consents were obtained. Afterwards, the Descriptive Information Form, the State-Trait Anxiety Inventory, and the Surgery-Specific Anxiety Inventory were administered. A training booklet was prepared by the researchers in line with the recommendations of the European Association of Urology and the relevant literature. The training took an average of 25-30 minutes. Afterwards, the questions of the patients were answered and the training booklet was given to the patient.The scales were reapplied on the morning of the surgery. Before discharge, the State Anxiety Scale and the Readiness to Discharge Scale-Patient Self-Assessment Form were administered. Then, the Adult Patient Discharge Readiness Scale-Nurse Evaluation Short Form was filled by the clinical nurse caring for the patient. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Agreeing to participate in the research and volunteering,
- Those between the ages of 18-65,
- Having URS surgery for the first time due to stone and temporary DJ stent placed,
- Patients whose cognitive level scales were suitable for application were included in the study.
Key exclusion criteria (4 listed)
- Having URS surgery for non-stone causes,
- Permanent stent placed,
- Leaving work voluntarily,
- Patients with major hearing and vision problems were not included in the study.
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 BookletExcretory system organs, signs and symptoms to be seen in kidney and ureteral stones, treatment methods, ureteroscopy procedure, what to do before and on the morning of surgery, and surgery, using the training booklet prepared by the researchers in line with the recommendations of the European Association of Urology and the relevant literature. An average of 25-30 minutes of training was given in the patient's room in an encouraging language, allowing the patient to ask questions about the situations he would encounter in the clinic after the surgery. She started asking questions she didn't understand. Afterwards, the questions of the patients were answered and the patient was given a training booklet. | Other | Patient Education Booklet |
Primary outcome
State-Trait Anxiety İnventory (STAI-I, STAI-II)
Time frame: up to 24 hours
It is a test developed by Spielberger et al. that measures state and trait anxiety levels. Its validity and reliability in Turkey was done by Owner and Le Compte. The scale consists of two parts, the 'state anxiety scale', which is created with the aim of determining the instantaneous feelings, and the 20-item 'trait anxiety scale', which was created to determine the feelings in general. It is a four degree scale ranging from 'Nothing' to 'All'. Scores range from 20 (low anxiety) to 80 (high anxiety).
Surgery Specific Anxiety Scale
Time frame: up to 24 hours
This scale was developed in Turkish by Karancı and Dirik in 2003 to measure the pre- and postoperative anxiety of surgical patients. It consists of 10 items in total. Each item is rated on a 5-point Likert-type scale. The surgery-specific anxiety score is obtained by summing the responses to all items. The minimum score that can be obtained from the scale is 10, and the maximum score is 50.
Readiness for Hospital Discharge Scale for Adult Patients-Short Form and Readiness for Hospital Discharge Scale- Adult-Nurse Assesment Short Form
Time frame: up to 24 hours
The scale developed by Weiss et al. in 2006 was used by Kaya et al. It was adapted to Turkish in 2018 and has parallel questions with the nurse version, and has a 10-point Likert-type evaluation. The scale, in which the patients' readiness for discharge is evaluated by themselves, consists of eight items and four sub-dimensions. Eight questions in the scale are evaluated with scores between 0-10, from the lowest to the highest.
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 23 Aug 2022.
Related trials for Kidney Calculi
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
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.
Muazzez Merve TORAMAN principal investigator
Ataturk University
2 sites 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 Kidney Calculi, run by Ataturk University at 2 sites 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 23 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 2 sites 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?
State-Trait Anxiety İnventory (STAI-I, STAI-II) (time frame: up to 24 hours). The study lists 3 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 23 Aug 2022.