NCT05511545

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

November 3, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

7 months

First QC Date

August 17, 2022

Last Update Submit

August 19, 2022

Conditions

Keywords

anxiety, double j stent, nurse, education, ureteroscopy

Outcome Measures

Primary Outcomes (3)

  • 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).

    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.

    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.

    up to 24 hours

Study Arms (1)

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.

Other: Patient Education Booklet

Interventions

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.

Patient Education Booklet

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Muazzez Merve TORAMAN

Erzurum, Palandöken, 25000, Turkey (Türkiye)

Location

Muazzez Merve TORAMAN

Erzurum, 2500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney CalculiAnxiety Disorders

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Muazzez Merve TORAMAN

    Ataturk University

    PRINCIPAL INVESTIGATOR

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

August 17, 2022

First Posted

August 23, 2022

Study Start

November 3, 2021

Primary Completion

May 30, 2022

Study Completion

July 1, 2022

Last Updated

August 23, 2022

Record last verified: 2022-08

Locations