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Clinical Trials/NCT07101172
NCT07101172Enrolling By InvitationNot Applicable

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

Hitit University1 site in 1 country66 target enrollmentStarted: October 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
66
Locations
1
Primary Endpoint
Personal Information Form

Study Overview

Brief Summary

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".

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

control group

No Intervention

Stress Ball

Experimental

Intervention: stress ball (Procedure)

Outcomes

Primary Outcomes

Personal Information Form

Time Frame: 12 months

Personal Information Form : This form, developed by the researcher based on literature, includes the age, education level, marital status, employment status, income level, daily pain coping strategies, stress coping strategies, previous surgery history, and whether patients are aware of prostate biopsy. It consists of nine questions . It will be used to determine the individual characteristics of the patient.

Visual Analog Scale (VAS)

Time Frame: 12 months

Visual Analog Scale (VAS) : This scale is used to assess the severity of pain. It is usually a 10 cm long horizontal or vertical line that begins with "No pain" and ends with "Unbearable pain." It will be used to determine the patient's pain intensity.

State Anxiety Inventory (STAI-S)

Time Frame: 12 months

State Anxiety Inventory (STAI-S) (Appendix 3): The State Anxiety Inventory has two subscales, each consisting of 20 items. The State Anxiety Inventory (STAI-S) describes how individuals feel under different circumstances and in the moment, while the Trait Anxiety Inventory (STAI-T) describes how they generally feel in their lives. The inventory is a 4-point Likert-type scale, with ratings based on the severity of the emotions and behaviors in the State and Trait Anxiety Subscales. According to the results, average anxiety scores range from 36 to 41, with scores above indicating high anxiety and below indicating low anxiety. It will be used to determine the patient's anxiety level.

Patient Follow-up Form

Time Frame: 12 months

Patient Follow-up Form: This is the form created to record the vital signs of the patients \[pulse, respiratory rate, systolic blood pressure (SBP), diastolic blood pressure (DBP) and oxygen saturation values (SpO2)) measured by the researcher before and after the procedure. It will be used to monitor and evaluate the patient's vital signs.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hitit University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zehra UNAL

assistant professor

Hitit University

Study Sites (1)

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