NCT06715202

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

November 28, 2024

Last Update Submit

November 28, 2024

Conditions

Keywords

Ureteral Stent (DJ), Symptom Management, Quality of Life

Outcome Measures

Primary Outcomes (1)

  • 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

    The universe of the study, between April and November 2022.

Study Arms (1)

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.

Procedure: Patient Education Booklet

Interventions

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.

Experimental: Patient Education Booklet

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Having URS surgery for reasons other than stones
  • Having a permanent stent
  • Having major hearing and vision impairment
  • Using antidepressants or anxiolytics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muazzez Merve TORAMAN

Erzurum, 2500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ureteral Calculi

Condition Hierarchy (Ancestors)

UreterolithiasisUreteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 4, 2024

Study Start

April 1, 2022

Primary Completion

August 30, 2022

Study Completion

November 30, 2022

Last Updated

December 4, 2024

Record last verified: 2024-11

Locations