Impact of Procedure Materials on Patient Anxiety, Depression, and Pain in Prostate Biopsy Consent
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Anxiety Level
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •patient's clinical data indicated the need for a prostate biopsy
排除标准
- •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
研究组 & 干预措施
written consent group
Only traditional written consent will be provided to this group.
photo-consent group
Photo consent which show materials use in procedure will be provided to this group before the biopsy
干预措施: Photo consent (Other)
结局指标
主要结局
Anxiety Level
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Depression Level(Immediately after the procedure)
- Anxiety Level(Immediately after the procedure)
- Pain Level(Immediately after the procedure)