Evaluate the Impact of Dynamic Video Education Versus Static Images and Verbal Instruction on Pain Perception and Anxiety in Patients Undergoing Transrectal Ultrasound-guided Prostate Biopsy (TRUS-Bx).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 223
- 试验地点
- 2
- 主要终点
- The importance of biopsy procedure information
研究概览
简要总结
This study aimed to assess the impact of dynamic video education versus static images and verbal instruction on pain perception and anxiety in patients undergoing transrectal ultrasound-guided prostate biopsy (TRUS-Bx).
Participants were allocated to three groups: control (verbal information), video (verbal information accompanied by dynamic video), and image (verbal information supplemented by static images). Pain intensity was quantified utilizing the Visual Analog Scale (VAS), while anxiety was evaluated with the State-Trait Anxiety Inventory (STAI) prior to and following the surgery.
详细描述
Prostate cancer is among the most common malignancies diagnosed globally and constitutes the second highest cause of cancer-related mortality in males. Timely identification is crucial for enhancing clinical results, directing suitable therapy alternatives, and ultimately elevating survival rates. Transrectal ultrasound-guided prostate biopsy (TRUS-Bx) is the definitive diagnostic method for acquiring tissue samples from suspected prostate lesions. This method is preferred because of its comparatively low expense, extensive accessibility, and significant diagnostic efficacy.
Although categorized as a minimally invasive technique, TRUS-Bx can induce significant psychological anguish in patients. Pre-procedural anxiety is prevalent and can stem from various factors: dread of discomfort related with the biopsy, concern regarding a possible cancer diagnosis, and lack of familiarity or misunderstanding about the biopsy procedure. This worry is not solely an emotional concern; it can negatively impact physiological metrics such as blood pressure and heart rate, heighten the perceived discomfort during the surgery, and diminish patient compliance. Furthermore, elevated anxiety levels are associated with diminished patient satisfaction and can adversely affect patients' readiness to pursue essential medical procedures in the future, potentially resulting in long-term health repercussions.
Reducing preoperative anxiety is essential for patient-centered treatment in procedural medicine. Effective educational interventions have demonstrated the capacity to alleviate anxiety by improving patient comprehension and establishing reasonable expectations. Conventional approaches encompass oral elucidations by healthcare professionals and printed pamphlets, whose efficacy fluctuates owing to disparities in literacy, attention, and retention among patients. Visual aids, particularly educational movies, provide a multimodal learning experience by integrating aural narrative with dynamic visuals, which may enhance understanding and engagement.
Prior studies on diverse medical procedures, including colonoscopy, endoscopy, and small surgical interventions, have shown that video-based teaching can markedly boost patients' understanding, alleviate anxiety, and improve overall satisfaction with the care experience. Nonetheless, despite the prevalent application of TRUS-Bx, there is a scarcity of data investigating the particular influence of video education in this domain. Moreover, it is uncertain whether dynamic video content (e.g., animated or actual procedural footage) provides benefits over static visuals or verbal information alone in mitigating anxiety and perceived pain associated with prostate biopsy.
Moreover, due to the growing accessibility of internet video platforms such as YouTube, individuals frequently pursue information autonomously before undergoing medical operations. Although this can empower patients, the quality and accuracy of such content fluctuate significantly, potentially affecting their psychological condition in unforeseen manners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men between 50 and 80 years of age
- •Elevated prostate-specific antigen (PSA) levels and/or suspicious digital rectal examination (DRE) findings
- •Literacy and comprehension
排除标准
- •A history of previous prostate biopsy
- •Cognitive or psychiatric disorders
- •Using anxiolytic medications
- •After being informed, declining to participate in the study
研究组 & 干预措施
Control Group
The control group received verbal information regarding the biopsy procedure.
干预措施: Visual Analog Scale (Other)
Control Group
The control group received verbal information regarding the biopsy procedure.
干预措施: State-Trait Anxiety Inventory (Other)
Video Group
The Video Group viewed a brief video about TRUS-Bx that was sourced from a frequently utilized video-sharing platform.
干预措施: Visual Analog Scale (Other)
Video Group
The Video Group viewed a brief video about TRUS-Bx that was sourced from a frequently utilized video-sharing platform.
干预措施: State-Trait Anxiety Inventory (Other)
Video Group
The Video Group viewed a brief video about TRUS-Bx that was sourced from a frequently utilized video-sharing platform.
干预措施: Video (Other)
Image Group
The image group (Image Group) was provided with information and still images that depicted the biopsy procedure.
干预措施: Visual Analog Scale (Other)
Image Group
The image group (Image Group) was provided with information and still images that depicted the biopsy procedure.
干预措施: State-Trait Anxiety Inventory (Other)
Image Group
The image group (Image Group) was provided with information and still images that depicted the biopsy procedure.
干预措施: Image (Other)
结局指标
主要结局
The importance of biopsy procedure information
时间窗: Through study completion, an average of 1 year
The research indicates that an increase in patients' anxiety-stress ratings will require the implementation of supplementary measures to notify patients prior to the treatment. Patients who decline the surgery may encounter delays in diagnosis and treatment, or these may be entirely omitted, owing to the visual information and videos acquired prior to the procedure. This study will additionally function as a reference for image alteration on digital platforms. By assessing the levels of anxiety and discomfort induced by visual and verbal input, modifications can be implemented in the information processes related to the procedure.
Assessment of pain intensity associated with the biopsy operation
时间窗: Through study completion, an average of 1 year]
The Visual Analog Scale (VAS) is a linear measurement tool used to assess perceived pain intensity, ranging from 0 (indicating no pain) to 10 (representing the most severe pain), where patients indicate the level that most accurately represents their experience. All measurements were conducted in a tranquil environment immediately prior to and following the biopsy process.
Evaluation of anxiety levels related to the biopsy procedure
时间窗: Through study completion, an average of 1 year
The STAI is a self-administered questionnaire with two elements: STAI-1 measures state anxiety, representing a transient emotional state elicited by a particular circumstance, while STAI-2 examines trait anxiety, signifying a consistent predisposition to experience anxiety across diverse situations. State-Trait Anxiety Inventory, Form 1 and Form 2 (STAI-1 and STAI-2). It is a Likert scale. The cumulative score derived from both measures runs from 20 (indicating mild anxiety) to 80 (indicating excessive anxiety). Diverse scoring methodologies are available for STAI-1 and STAI-2 scores.
The importance of biopsy procedure information
时间窗: Through study completion, an average of 1 year
The research indicates that an increase in patients' anxiety-stress ratings will require the implementation of supplementary measures to notify patients prior to the treatment. Patients who decline the surgery may encounter delays in diagnosis and treatment, or these may be entirely omitted, owing to the visual information and videos acquired prior to the procedure. This study will additionally function as a reference for image alteration on digital platforms. By assessing the levels of anxiety and discomfort induced by visual and verbal input, modifications can be implemented in the information processes related to the procedure.
Assessment of pain intensity associated with the biopsy operation
时间窗: Through study completion, an average of 1 year]
The Visual Analog Scale (VAS) is a linear measurement tool used to assess perceived pain intensity, ranging from 0 (indicating no pain) to 10 (representing the most severe pain), where patients indicate the level that most accurately represents their experience. All measurements were conducted in a tranquil environment immediately prior to and following the biopsy process.
Evaluation of anxiety levels related to the biopsy procedure
时间窗: Through study completion, an average of 1 year
The STAI is a self-administered questionnaire with two elements: STAI-1 measures state anxiety, representing a transient emotional state elicited by a particular circumstance, while STAI-2 examines trait anxiety, signifying a consistent predisposition to experience anxiety across diverse situations. State-Trait Anxiety Inventory, Form 1 and Form 2 (STAI-1 and STAI-2). It is a Likert scale. The cumulative score derived from both measures runs from 20 (indicating mild anxiety) to 80 (indicating excessive anxiety). Diverse scoring methodologies are available for STAI-1 and STAI-2 scores.
次要结局
未报告次要终点
研究者
Fatih SANDIKCI
Dr. Fatih SANDIKCI, Urology Specialist, Principal Investigator
Ankara Etlik City Hospital