Effects of Music and Conversation in Prostate Biopsy (TRUS-BX)

Bozok University

Status: Completed

Conditions: Prostate Biopsy; Prostate Neoplasms

Treatments: Behavioral: Conversation; Behavioral: Music intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07006779

2017-KAEK-189_2021.05.05_08

Details and patient eligibility

About

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

Full 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."

Enrollment: 90 patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Music intervention

Experimental group

Description:

The patients who listened to music during procedure

Treatment:

Behavioral: Music intervention

Conversation

Experimental group

Description:

The patients who were involved into conversation during procedure

Treatment:

Behavioral: Conversation

Control

No Intervention group

Description:

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