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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06802783
Enrollment
40
Registered
2025-01-31
Start date
2024-01-01
Completion date
2025-01-30
Last updated
2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Biopsy

Keywords

prostate biopsy, anxiety, pain, depression

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

Interventions

OTHERPhoto 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.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Anxiety LevelPre-procedureFor 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 LevelPre-procedureFor 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 LevelPre procedureFor 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

MeasureTime frameDescription
Anxiety LevelImmediately after the procedureFor 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 LevelImmediately after the procedureFor 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 LevelImmediately after the procedureFor 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026