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Completed

NCT Number: NCT07156747

The Impact of Video Education on Pain and Anxiety in Patients Undergoing Transrectal Ultrasonography-Guided Prostate Biopsy

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.

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Key information

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

About this study

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.

Research Aim

This study seeks to systematically assess the impact of pre-procedural video education regarding TRUS-Bx on patients' anxiety and subjective pain levels. The researchers aim to compare the impact of dynamic, detailed videos-akin to those found on popular platforms such as YouTube-with static image displays or traditional spoken therapy. The fundamental premise posits that exposure to extensive, dynamic video information before biopsy will adequately prepare patients by clarifying the technique, therefore alleviating psychological discomfort and enhancing their overall experience.

This study aims to clarify the function of video-based instructional aids in the clinical environment, intending to guide best practices for patient education and aid in the formulation of standardized procedures to enhance patient-centered outcomes in prostate cancer diagnosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • A history of previous prostate biopsy
  • Cognitive or psychiatric disorders
  • Using anxiolytic medications
  • After being informed, declining to participate in the study

Treatment and study plan

Visual analog scale

Other

The Visual Analog Scale (VAS) is a linear instrument employed to measure perceived pain intensity, spanning from 0 (indicating no pain) to 10 (representing the most severe pain), where patients indicate the level that most accurately represents their experience.

State-Trait Anxiety Inventory

Other

The STAI is a self-administered questionnaire with two parts: STAI-1 measures state anxiety, representing a transient emotional state triggered by a particular circumstance, while STAI-2 examines trait anxiety, denoting a consistent predisposition to experience anxiety across diverse situations.

video

Other

watching video on Digital Platfrom (for example, Youtube)

Image

Other

Prostate biopsy information with images

Primary outcomes

  1. The importance of biopsy procedure information

    Time frame: 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.

  2. Assessment of pain intensity associated with the biopsy operation

    Time frame: 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.

  3. Evaluation of anxiety levels related to the biopsy procedure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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).

Acronym: TRUS

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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