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

ConditionStress
Trial statusCompleted
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorMersin University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older,

Conscious and cooperative,

Able to speak and understand Turkish,

With stable general condition and hemodynamic variables,

Disqualifiers

Under 18 years of age,

Not conscious or not cooperative,

Unable to speak or understand Turkish,

With unstable general condition or hemodynamic variables,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stress ball

    Other intervention

    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

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: stress ballExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions

Trial outcomes

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.

Time frame
Before, During, immediately after, 15 minutes after biopsy

Secondary outcomes

1

Visual Analog Scale for Anxiety (VAS-A)

The VAS was developed to convert certain values that cannot be measured numerically into numerical form. Widely recognized in the global 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 = none, 10 cm = maximum). According to previous research, the VAS has been used to assess anxiety levels in surgical patients. Individuals mark the point on the 10-cm line that corresponds to their perceived anxiety. The distance from the start of the line to the marked point is measured with a ruler, and the individual's anxiety level is quantified in centimeters. A low score obtained from the VAS indicates a low/minimal level of anxiety, whereas a high score indicates a high/severe level of anxiety.

Time frame
Before, During, immediately after, 15 minutes after biopsy
2

Systolic blood pressure changes after stress ball

This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.

Time frame
Before, During, immediately after, 15 minutes after biopsy
3

Diastolic blood pressure changes after stress ball

This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.

Time frame
Before, immediately after, 15 minutes and 30 minutes after biopsy
4

Heart rate changes after stress ball

This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.

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

Other outcomes

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