- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05511545
The Effect of Education Given to Patients on Pre- and Post-operative Anxiety and Preparation for Discharge
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Erzurum, Turkey, 2500
- Muazzez Merve TORAMAN
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Palandöken
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Erzurum, Palandöken, Turkey, 25000
- Muazzez Merve TORAMAN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Patient Education Booklet
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. |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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State-Trait Anxiety İnventory (STAI-I, STAI-II)
Time Frame: up to 24 hours
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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).
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up to 24 hours
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Surgery Specific Anxiety Scale
Time Frame: up to 24 hours
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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.
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up to 24 hours
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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
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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.
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up to 24 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muazzez Merve TORAMAN, Ataturk University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Muazzez
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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