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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| written consent group | No Intervention | Only traditional written consent will be provided to this group. | |
| photo-consent group | Active Comparator | Photo consent which show materials use in procedure will be provided to this group before the biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Pre procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after the procedure |
| Depression Level |
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Inclusion Criteria:
- patient's clinical data indicated the need for a prostate biopsy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| BAHADIR SAHIN | MARMARA UNÄ°VERSÄ°TY SCHOOL OF MEDÄ°CÄ°NE DEPARTMENT OF UROLOGY | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University School of Medicine Urology Department | Istanbul | Istanbul | 34854 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
| 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. | Immediately after the procedure |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |