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Completed

NCT Number: NCT07006779

Effects of Music and Conversation in Prostate Biopsy

The goal of this observational study is to learn about the effects of music and conversation on pain and anxiety levels during Transrectal Ultrasound-Guided Prostate Biopsy. The main question it aims to answer is:

Does music or conversation reduces the pain and anxiety levels of patients

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Key information

About this study

The patients who were scheduled to undergo TRUS-PBx were randomly assigned to one of three groups (n=30) via sealed envelope randomization method: the control group, the music group, and the conversation group.

Patients' sociodemographic data such as age, height, weight and body mass index were documented. The International Prostate Symptom Score (IPSS), PSA level and prostate volume of all patients was recorded before the procedure. Blood pressure and heart rate were checked before and after the procedure.

Patients completed the State-Trait Anxiety Inventory (STAI) test, which consists of 40 questions, with 20 questions each in the state and trait subscales, both before and after the procedure. Low scores indicated low anxiety levels, while high scores reflected higher anxiety levels. Also, anxiety and pain levels were assessed using a visual analog scale (VAS).

The procedure room was designed to minimize external disturbances (e.g., sound or noise). Prior to the biopsy, patients received detailed information according to their assigned group. In the music group, patient-selected music was played throughout the procedure. In the conversation group, discussions based on the patients' interests were initiated and continued during the procedure. In the control group, no additional interaction beyond the informational briefing was provided.

Post-procedure, patients were asked whether they would be willing to undergo the procedure again if necessary. Responses were categorized as "positive," "negative," or "abstained."

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • pathological findings on Digital Rectal Examination
  • PSA value greater than 2.5 ng/ml

Exclusion criteria

  • psychiatric disorders,
  • those who declined to participate,
  • hearing or perceptual impairments,
  • continuous analgesic use,
  • history of prior prostate biopsy,
  • prilocaine allergy were excluded.

Treatment and study plan

Music intervention

Behavioral

Engaging into conversation during procedure

Other names: Conversation

Conversation

Behavioral

Engaging patients into conversation

Primary outcomes

  1. Visual Analog Scale of Pain

    Time frame: Periprocedural

    pain levels were assessed using a visual analog scale (VAS), where a score of "0" indicated "no pain or anxiety," and a score of "10" represented "the most severe pain

  2. Visual Analog Scale of Anxiety

    Time frame: Periprocedural

    Anxiety levels were assessed using a visual analog scale (VAS), where a score of "0" indicated "no pain or anxiety," and a score of "10" represented "the most severe anxiety

  3. State-Trait Anxiety Inventory (STAI) test

    Time frame: Periprocedural

    State-Trait Anxiety Inventory (STAI) test, which consists of 40 questions, with 20 questions each in the state and trait subscales, both before and after the procedure. The test was scored using a 4-point Likert scale, with total scores ranging from 20 to 80. Low scores indicated low anxiety levels, while high scores reflected higher anxiety levels.

Sponsors and collaborators

Lead sponsor

Bozok University

Other

Registry information

Official study title

Effects of Music and Conversation on Pain and Anxiety Levels During Transrectal Ultrasound-Guided Prostate Biopsy: A Randomized-Controlled Prospective Study

Acronym: TRUS-BX

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2025
Registry last updated
Jun 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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