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Effects of Music and Conversation in Prostate Biopsy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07006779
Acronym
TRUS-BX
Enrollment
90
Registered
2025-06-05
Start date
2021-06-01
Completion date
2021-12-01
Last updated
2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Biopsy, Prostate Neoplasms

Keywords

prostate biopsy, music, conversation, anxiety, pain

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.

Interventions

BEHAVIORALMusic intervention

Engaging into conversation during procedure

BEHAVIORALConversation

Engaging patients into conversation

Sponsors

Bozok University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale of PainPeriproceduralpain 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
Visual Analog Scale of AnxietyPeriproceduralAnxiety 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
State-Trait Anxiety Inventory (STAI) testPeriproceduralState-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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026