Ireland
--:--IST
Active, not recruiting Not applicable

Impact of Procedure Materials on Patient Anxiety, Depression, and Pain in Prostate Biopsy Consent

NCT06802783 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-01-01
Last updated
2025-01-31

Condition(s) studied

Prostate Biopsy

Investigational drug(s) / intervention(s)

Photo consent

Photo consent: The first group was shown photographs of the devices alongside the written consent form, while the second group received only the written consent. The study compared the pain, depression and anxiety scores between the two groups.

Study summary

The gold standard for diagnosing prostate cancer is an ultrasound-guided prostate biopsy. Despite its low complication rates, the procedure can cause significant stress, discomfort and anxiety in patients. This study aimed to determine whether visually introducing the materials (ultrasound, probe, biopsy needle) used during the biopsy could reduce patient anxiety and increase comfort.

Eligibility

Sex
MALE
Min age
—
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: \- patient's clinical data indicated the need for a prostate biopsy Exclusion Criteria: * included having a diagnosis of psychiatric illness * having previously undergone a prostate biopsy under local anesthesia * being a patient under active surveillance for prostate cancer

Primary outcome measure(s)

  • Anxiety Level — Pre-procedure
    For Anxiety, Hospital Anxiety Scale used. In the Hospital Anxiety Score, the minimum score is 0, and the maximum score is 21. As the score increases, it indicates higher levels of anxiety.
  • Depression Level — Pre-procedure
    For Depression, Hospital Depression Scale used . In the Hospital Depression Score, the minimum score is 0, and the maximum score is 21. As the score increases, it indicates higher levels of depression.
  • Pain Level — Pre procedure
    For Pain, Visual Analog Scale used. In the Visual Analog Pain Scale, the minimum score is 0, and the maximum score is 10. As the score increases, it indicates higher levels of pain.

Trial sites (1)

FacilityCityRegionStatus
Marmara University School of Medicine Urology Department Istanbul Istanbul

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06802783 on ClinicalTrials.gov ↗ ← All trials in Turkey