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

NCT ID: NCT07101172

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-08-01

Brief Summary

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

Detailed Description

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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".

Conditions

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Anxiety Pain Prostate Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Stress Ball

Group Type EXPERIMENTAL

stress ball

Intervention Type PROCEDURE

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 drawn up toward their abdomen. The environment will be quiet and free from external stimuli. During the biopsy procedure, the patient will be asked to squeeze and release the Stre ball once every five counts for 10 minutes. Because blood pressure may drop or dizziness may occur after the procedure, the patient will be taken to the recovery room and monitored for bleeding. Fifteen minutes after the procedure, the severity of pain and anxiety levels during the procedure will be determined, and vital

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 drawn up toward their abdomen. The environment will be quiet and free from external stimuli. During the biopsy procedure, the patient will be asked to squeeze and release the Stre ball once every five counts for 10 minutes. Because blood pressure may drop or dizziness may occur after the procedure, the patient will be taken to the recovery room and monitored for bleeding. Fifteen minutes after the procedure, the severity of pain and anxiety levels during the procedure will be determined, and vital

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hitit University

OTHER

Sponsor Role lead

Responsible Party

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Zehra UNAL

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hitit University

Çorum, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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HititZU

Identifier Type: -

Identifier Source: org_study_id

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