The Effect of Using a Stress Ball During Transrectal Ultrasound-Guided Prostate Biopsy on Anxiety, Pain, and Hemodynamic Variables

NCT07507617 | Not Yet Recruiting DMC

• 2 other identifiers: Mersin_UnıvTuğba ÇAM YANIK
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The Effect of Using a Stress Ball During Transrectal Ultrasound-Guided Prostate Biopsy on Anxiety, Pain, and Hemodynamic Variables

Conditions

Stress

Keywords

Biopsy; Pain; Stress; Stress ball

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  he Visual Analog Scale (VAS), developed by Freyd in 1923, is a single-line scale, 10 cm in length, which can be used either vertically or horizontally to assess pain intensity. Widely recognized in the literature as a safe and easily applicable tool, the VAS consists of a 10-cm line with subjective descriptive labels at both ends (0 cm = no pain, 10 cm = worst possible pain). Individuals mark the point on the line that corresponds to their perceived pain level. The distance from the start of the line to the marked point is measured with a ruler, and the individual's pain intensity is quantified in centimeters.

  Before, During, immediately after, 15 minutes after biopsy

Secondary Outcomes (6)

• Visual Analog Scale for Anxiety (VAS-A)

  Before, During, immediately after, 15 minutes after biopsy

• Systolic blood pressure changes after stress ball

  Before, During, immediately after, 15 minutes after biopsy

• Diastolic blood pressure changes after stress ball

  Before, immediately after, 15 minutes and 30 minutes after biopsy

• Heart rate changes after stress ball

  Before, immediately after, 15 minutes and 30 minutes after biopsy

• Respiratory rate changes after stress ball

  Before, immediately after, 15 minutes and 30 minutes after chest tube removal

Study Arms (2)

stress ball

EXPERIMENTAL

After the preparation phase of the procedure is completed and the data collection form is filled out, patients will be given a stress ball, and its use will be demonstrated by E.K.D. The stress ball intervention will be performed during the biopsy procedure for an average duration of 10 minutes. A round, medium-firm silicone ball with an approximate diameter of 6 cm, made of high-quality materials, will be used in the application. Patients will be instructed to place the ball in the palm of their hand, count to three, then squeeze and release it once. They will be informed that they should continue this practice for 10 minutes and focus their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with single-use aseptic wipes before being given to the patient. During the biopsy procedure, the Visual Analog Scale (VAS), VAS-A, and hemodynamic variables of both the intervention and control groups will be evaluated again by the researchers at three ti

Other: Stress ball

control

NO INTERVENTION

For the control group, no intervention other than routine care will be applied, and evaluations will be conducted at the same time points as for the intervention group. During the biopsy procedure, the Visual Analog Scale (VAS), VAS-A, and hemodynamic variables of control groups will be reassessed by the researchers at three time points: approximately 5 minutes after the start of the biopsy, immediately after the completion of the biopsy, and 15 minutes after the procedure.

Interventions

Stress ball OTHER

The stress ball intervention will be performed during the biopsy procedure for an average duration of 10 minutes. A round, medium-firm silicone ball with an approximate diameter of 6 cm, made of high-quality materials, will be used in the application. Patients will be instructed to place the ball in the palm of their hand, count to three, then squeeze and release it once. They will be informed that they should continue this practice for 10 minutes and focus their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with single-use aseptic wipes before being given to the patient. During the biopsy procedure, the Visual Analog Scale (VAS), VAS-A, and hemodynamic variables of both the intervention and control groups will be evaluated again by the researchers at three time points

stress ball

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older,
• Conscious and cooperative,
• Able to speak and understand Turkish,
• With stable general condition and hemodynamic variables,
• Scheduled for the procedure,
• Without any psychiatric diagnosis,
• Not using psychiatric and/or local neuromuscular blocking medications,
• Willing to participate in the study (having signed the Informed Consent Form).

You may not qualify if:

• Under 18 years of age,
• Not conscious or not cooperative,
• Unable to speak or understand Turkish,
• With unstable general condition or hemodynamic variables,
• Undergoing emergency surgical procedures,
• Having a current psychiatric diagnosis,
• Using psychiatric and/or local neuromuscular blocking medications,
• Unwilling to participate in the study (not signing the Informed Consent Form).

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Turkey, Mersin University,

Yenişehir, Mersin, 33120, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tuğba YANIK, PHD

CONTACT

+905067703216; tugbacam@mersin.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this study, participants cannot be blinded because only patients in the intervention group will receive the application. Upon completion of the study, the data of the intervention and control groups (coded as A or B) will be transferred to a computer by an independent researcher. The data will then be analyzed and reported by a statistician using a blinded approach. Therefore, the study will be conducted as a single-blind clinical trial.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgical Diseases Nursing

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: April 6, 2026
• Primary Completion: April 6, 2026
• Study Completion (Estimated): April 6, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)