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Active, Not Recruiting

NCT Number: NCT06802783

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University School of Medicine Urology Department

Istanbul, 34854, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Photo consent

Other

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.

Primary outcomes

  1. Anxiety Level

    Time frame: 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.

  2. Depression Level

    Time frame: 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.

  3. Pain Level

    Time frame: 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 outcomes

  1. Anxiety Level

    Time frame: 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.

  2. Depression Level

    Time frame: 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

  3. Pain Level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 31, 2025
Registry last updated
Jan 31, 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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