Effects of Music and Conversation in Prostate Biopsy

NCT07006779 | Completed

• 1 other identifier: 2017-KAEK-189_2021.05.05_08
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Neoplasms; Prostate Biopsy

Keywords

prostate biopsy; music; conversation; anxiety; pain

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale of Pain

  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

  Periprocedural

• Visual Analog Scale of Anxiety

  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

  Periprocedural

• State-Trait Anxiety Inventory (STAI) test

  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.

  Periprocedural

Study Arms (3)

Music intervention

EXPERIMENTAL

The patients who listened to music during procedure

Behavioral: Music intervention

Conversation

EXPERIMENTAL

The patients who were involved into conversation during procedure

Behavioral: Conversation

Control

NO INTERVENTION

The patients who were not involved into conversation or listened to music during procedure

Interventions

Music intervention BEHAVIORAL

Engaging into conversation during procedure

Also known as: Conversation

Music intervention

Conversation BEHAVIORAL

Engaging patients into conversation

Conversation

Eligibility Criteria

• Gender Eligibility Details: Male patients
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bozok University: lead

Study Sites (1)

Yozgat Bozok University Research and Training Hospital

Yozgat, Yozgat, 66100, Turkey (Türkiye)

Location

Related Publications (4)

• Chiu LP, Tung HH, Lin KC, Lai YW, Chiu YC, Chen SS, Chiu AW. Effectiveness of stress management in patients undergoing transrectal ultrasound-guided biopsy of the prostate. Patient Prefer Adherence. 2016 Feb 11;10:147-52. doi: 10.2147/PPA.S96991. eCollection 2016.

  PMID: 26929606 BACKGROUND

• Cho SW, Choi HJ. Effect of Music on Reducing Anxiety for Patients Undergoing Transrectal Ultrasound-Guided Prostate Biopsies: Randomized Prospective Trial. Urol J. 2016 Apr 16;13(2):2612-4.

  PMID: 27085561 BACKGROUND

• Chang YH, Oh TH, Lee JW, Park SC, Seo IY, Jeong HJ, Kwon WA. Listening to music during transrectal ultrasound-guided prostate biopsy decreases anxiety, pain and dissatisfaction in patients: a pilot randomized controlled trial. Urol Int. 2015;94(3):337-41. doi: 10.1159/000368420. Epub 2014 Dec 18.

  PMID: 25531837 BACKGROUND

• Selmi V, Taspinar MS, Caniklioglu M, Sari S, Akyuz M, Isikay L. Effects of music and conversation on pain and anxiety levels during transrectal ultrasound-guided prostate biopsy: a randomized-controlled prospective study. Sao Paulo Med J. 2025 Dec 15;144(1):e20253273. doi: 10.1590/1516-3180.2025.3273.28072025. eCollection 2025.

  PMID: 41417393 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Anxiety Disorders; Pain

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; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• volkan selmi

  Yozgat Bozok University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 5, 2025
• Study Start: June 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: December 1, 2021
• Last Updated: June 5, 2025

Record last verified: 2025-05

Locations

TU (1)