Clinical trial NCT07006779: Effects of Music and Conversation in Prostate Biopsy
Official title: Effects of Music and Conversation on Pain and Anxiety Levels During Transrectal Ultrasound-Guided Prostate Biopsy: A Randomized-Controlled Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Neoplasms
Prostate Biopsy
Keywords: prostate biopsy
music
conversation
anxiety
pain
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 90
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: 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."

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale of Pain
timeFrame: Periprocedural
measure: Visual Analog Scale of Anxiety
timeFrame: Periprocedural
measure: State-Trait Anxiety Inventory (STAI) test
timeFrame: Periprocedural
Secondary outcomes:
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Yozgat Bozok University Research and Training Hospital
Study officials:
affiliation: Yozgat Bozok University
name: volkan selmi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.