An interventional study of Photo consent in Prostate Biopsy, sponsored by Marmara University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-31.
Sponsored by Marmara University · Not applicable, Interventional, and Supportive care
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.
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
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Marmara University is the lead sponsor of 589 studies on the registry; 136 are open to participants now.
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- patient's clinical data indicated the need for a prostate biopsy
Exclusion Criteria:
Only traditional written consent will be provided to this group.
Photo consent which show materials use in procedure will be provided to this group before the biopsy
Other: 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.
Anxiety Level
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.
Time frame: Pre-procedure
Depression Level
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.
Time frame: Pre-procedure
Pain Level
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.
Time frame: Pre procedure
Anxiety Level
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.
Time frame: Immediately after the procedure
Depression Level
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
Time frame: Immediately after the procedure
Pain Level
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.
Time frame: Immediately after the procedure
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Nov 2024, 10 months.
Of 2,720 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 10 months is below that.
Counting every sponsor, half of 2,789 studies reached it within 12 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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