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Enrolling by Invitation

NCT Number: NCT07101172

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

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

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Prostate Biopsy Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hitit University

Çorum, Merkez, 19000, Turkey (Türkiye)

About this study

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".

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stress Ball

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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