Effects of Music and Conversation in Prostate Biopsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-12-01

Brief Summary

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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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Detailed Description

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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."

Conditions

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Prostate Neoplasms Prostate Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Music intervention

The patients who listened to music during procedure

Group Type EXPERIMENTAL

Music intervention

Intervention Type BEHAVIORAL

Engaging into conversation during procedure

Conversation

The patients who were involved into conversation during procedure

Group Type EXPERIMENTAL

Conversation

Intervention Type BEHAVIORAL

Engaging patients into conversation

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music intervention

Engaging into conversation during procedure

Intervention Type BEHAVIORAL

Conversation

Engaging patients into conversation

Intervention Type BEHAVIORAL

Other Intervention Names

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Conversation

Eligibility Criteria

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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.

Eligible Sex

MALE

Accepts Healthy Volunteers

No