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CompletedNCT05511545Updated Aug 23, 2022

The Effect of Education Given to Patients on Pre- and Post-operative Anxiety and Preparation for Discharge

An interventional study of Patient Education Booklet in Kidney Calculi, sponsored by Ataturk University. Completed at 2 sites in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-23.

Sponsored by Ataturk University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Nov 2021, registered Aug 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
122
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Kidney Calculi

Keywords

  • anxiety, double j stent, nurse, education, ureteroscopy
03

In context

Kidney Calculi

598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.

This study's enrollment of 122 is above the median of 90 across 461 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
122 participants (actual)

Study arms

  • 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.

    Other: Patient Education Booklet

Interventions

  • OtherPatient Education Booklet

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: up to 24 hours

  2. 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.

    Time frame: up to 24 hours

  3. 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.

    Time frame: up to 24 hours

07

Study locations

2 sites
  • Muazzez Merve TORAMAN
    Erzurum, Palandöken 25000, Turkey
  • Muazzez Merve TORAMAN
    Erzurum, 2500, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05511545
Lead sponsor
Ataturk University
Responsible party
Muazzez Merve TORAMAN (Research Assistant, Ataturk University) — Principal investigator
First posted
Aug 23, 2022
Start date
Nov 3, 2021
Primary completion
May 30, 2022
Completion
Jul 1, 2022
Last update
Aug 23, 2022

Study contacts

Muazzez Merve TORAMAN
principal investigator · Ataturk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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