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

NCT07156747 | Completed

• 1 other identifier: AESH-U-FS-01
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer; Prostate Biopsy; Anxiety

Keywords

Prostate Biopsy; Video Education; Pain Perception; Anxiety; Patient Preparation

Outcome Measures

Primary Outcomes (3)

• The importance of biopsy procedure information

  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.

  Through study completion, an average of 1 year

• Assessment of pain intensity associated with the biopsy operation

  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.

  Through study completion, an average of 1 year]

• Evaluation of anxiety levels related to the biopsy procedure

  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.

  Through study completion, an average of 1 year

Study Arms (3)

Control Group

EXPERIMENTAL

The control group received verbal information regarding the biopsy procedure.

Other: Visual Analog Scale; Other: State-Trait Anxiety Inventory

Video Group

EXPERIMENTAL

The Video Group viewed a brief video about TRUS-Bx that was sourced from a frequently utilized video-sharing platform.

Other: Visual Analog Scale; Other: State-Trait Anxiety Inventory; Other: Video

Image Group

EXPERIMENTAL

The image group (Image Group) was provided with information and still images that depicted the biopsy procedure.

Other: Visual Analog Scale; Other: State-Trait Anxiety Inventory; Other: Image

Interventions

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.

Control Group; Image Group; Video Group

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.

Control Group; Image Group; Video Group

Video OTHER

watching video on Digital Platfrom (for example, Youtube)

Video Group

Image OTHER

Prostate biopsy information with images

Image Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Gender Eligibility Details: Our study will be conducted on patients scheduled for prostate biopsy. Therefore, all participants are male.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Related Publications (5)

• Tarhan H, Cakmak O, Unal E, Akarken I, Un S, Ekin RG, Konyalioglu E, Isoglu CS, Zorlu F. The effect of video-based education on patient anxiety in men undergoing transrectal prostate biopsy. Can Urol Assoc J. 2014 Nov;8(11-12):E894-900. doi: 10.5489/cuaj.2208.

  PMID: 25553162 RESULT

• Sheng LP, Han CQ, Nie C, Xu T, Zhang K, Li XJ, Xie XR, Lin R, Ding Z. Watching Videos of Colonoscopies and Receiving Interpretations Reduce Pain and Anxiety While Increasing the Satisfaction of Patients. Dig Dis Sci. 2021 Feb;66(2):541-546. doi: 10.1007/s10620-020-06186-6. Epub 2020 Mar 19.

  PMID: 32193861 RESULT

• Bujnowska-Fedak MM, Wegierek P. The Impact of Online Health Information on Patient Health Behaviours and Making Decisions Concerning Health. Int J Environ Res Public Health. 2020 Jan 31;17(3):880. doi: 10.3390/ijerph17030880.

  PMID: 32023828 RESULT

• Monteiro Grilo A, Ferreira AC, Pedro Ramos M, Carolino E, Filipa Pires A, Vieira L. Effectiveness of educational videos on patient's preparation for diagnostic procedures: Systematic review and Meta-Analysis. Prev Med Rep. 2022 Jul 5;28:101895. doi: 10.1016/j.pmedr.2022.101895. eCollection 2022 Aug.

  PMID: 35855928 RESULT

• Sefik E, Gunlusoy B, Eker A, Celik S, Ceylan Y, Koskderelioglu A, Basmaci I, Degirmenci T. Anxiety and depression associated with a positive prostate biopsy result: A comparative, prospective cohort study. Int Braz J Urol. 2020 Nov-Dec;46(6):993-1005. doi: 10.1590/S1677-5538.IBJU.2019.0719.

  PMID: 32822128 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Anxiety Disorders

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Fatih SANDIKCI, Urology Specialist, Principal Investigator

Model Details: Participants were categorized into three groups. The control group received verbal information regarding the biopsy procedure. The film Group received a same verbal explanation and viewed a brief film regarding TRUS-Bx sourced from a widely utilized video-sharing platform. The picture group received verbal information accompanied by still photographs depicting the biopsy procedure. Participants in this trial were not randomized. Rather, they were allocated to groups according to their socioeconomic level. This was implemented to deliver education tailored to each patient's background and comprehension. All teaching initiatives were administered by the same qualified urology nurse to maintain consistency. A panel of urologists pre-selected the video and graphic elements for clarity, accuracy, and educational value.

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: September 5, 2025
• Study Start: December 10, 2023
• Primary Completion: December 30, 2024
• Study Completion: May 20, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)