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

Not Applicable

Active, not recruiting

• Conditions: Prostate Biopsy

• Registration Number: NCT06802783
• Lead Sponsor: Marmara University

Brief 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.

Detailed Description

Forty patients suspected of having prostate cancer were included in this prospective study. All patients received detailed information about the procedure, but they were divided into two groups. 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 Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-11-12
• Study First Submitted: 2024-12-23
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-26
• Last Update Submitted: 2025-01-26
• Study Completion: 2025-01-30
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Anxiety Level	Immediately after the 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	Immediately after the 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	Immediately after the 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 Locations

Locations (1)

Marmara University School of Medicine Urology Department; 🇹🇷 Istanbul, Turkey