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Enrolling by invitation NCT07101172

The Effectiveness of Stress Ball in Managing Anxiety and Pain During Prostate Biopsy

No phase Interventional Anxiety Pain Prostate Biopsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: stress ball.
Who it may be relevant to
Registry conditions: Anxiety, Pain, Prostate Biopsy. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Simple Approach to Managing Anxiety and Pain During Prostate Biopsy: Effectiveness of Stress Ball Application

Overview

This study aimed to determine the effectiveness of stress ball application in the management of anxiety and pain during prostate biopsy.

Detailed description

The aim of this study was to determine the effectiveness of stress ball application in managing anxiety and pain during prostate biopsy.

This experimental study was performed with experimental-control group (N=66) patients.Data will be collected using the "Personal Information Form", "Visual Analog Scale (VAS)", "State Anxiety Inventory (STAI-S)" and "Patient Follow-up Form".

Interventions

  • Procedure stress ball
    Patients will be provided with an explanation, and verbal and written consent will be obtained. A patient identification form will be completed 10 minutes before the procedure. Pain levels will be determined with a pre-test VAS, anxiety levels will be determined with a STAI-S, and vital signs will be measured and recorded. The patient will be undressed and helped into a surgical gown to protect their privacy. The patient will be placed in a left lateral position on a stretcher with both legs dra

Primary outcome measures

  • Personal Information Form [Time frame: 12 months]
  • Visual Analog Scale (VAS) [Time frame: 12 months]
  • State Anxiety Inventory (STAI-S) [Time frame: 12 months]
  • Patient Follow-up Form [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Patients who come to the Urology Service for a prostate biopsy, are willing to participate in the study, are over 18 years of age, are conscious, literate, have no visual or hearing impairments, no psychiatric diagnoses or neurological problems, are undergoing a prostate biopsy for the first time, and do not have weakness in their hands or arms to squeeze a ball will be included.

Exclusion criteria

  • Patients who do not volunteer to participate in the study, who wish to withdraw from the study, who are under 18 years of age, who are unconscious, illiterate, visually or hearing impaired, who have a psychiatric diagnosis or neurological problem, who have previously had a prostate biopsy, and who have weakness in the hand or arm for the ability to squeeze a ball will be excluded from the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Hitit University — Çorum

Identifiers

NCT: NCT07101172 · HititZU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗