Prostate NeoplasmsTRUS-BXNCT07006779
Effects of Music and Conversation in Prostate Biopsy
A study testing Music intervention and Conversation in people with Prostate Neoplasms and Prostate Biopsy, run by Bozok University at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Neoplasms, Prostate Biopsy
- What is being tested?
- Music intervention and Conversation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pathological findings on Digital Rectal Examination
- PSA value greater than 2.5 ng/ml
Who cannot join
- psychiatric disorders,
- those who declined to participate,
- hearing or perceptual impairments,
- continuous analgesic use,
- history of prior prostate biopsy,
- prilocaine allergy were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yozgat Bozok University Research and Training Hospital
Yozgat, Yozgat, 66100
About this study
Official title: Effects of Music and Conversation on Pain and Anxiety Levels During Transrectal Ultrasound-Guided Prostate Biopsy: A Randomized-Controlled Prospective Study
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
Read the 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."
- Conditions
- Prostate Neoplasms, Prostate Biopsy
- Being tested
- Music intervention, Conversation
- Keywords
- prostate biopsy, music, conversation, anxiety, pain
- Medical subject headings
- Prostatic Neoplasms, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionBehavioural
Also called Conversation
Engaging into conversation during procedure
ConversationBehavioural
Engaging patients into conversation
| Study group | Role | What they receive |
|---|---|---|
| Music intervention | Experimental | The patients who listened to music during procedure Receives: Behavioral: Music intervention |
| Conversation | Experimental | The patients who were involved into conversation during procedure Receives: Behavioral: Conversation |
| Control | No intervention | The patients who were not involved into conversation or listened to music during procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jun 2021
- Primary completion31 Oct 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Selmi, Bozok University
- Investigators
- volkan selmi, Principal investigator, Yozgat Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006779
- Sponsor's protocol ID
- 2017-KAEK-189_2021.05.05_08
- Acronym
- TRUS-BX
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26929606Cho 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.
PubMed 27085561Chang 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.
PubMed 25531837Selmi 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.
PubMed 41417393
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music and Conversation on Pain and Anxiety Levels During Transrectal Ultrasound-Guided Prostate Biopsy: A Randomized-Controlled Prospective Study
- ClinicalTrials.gov ID
- NCT07006779
- Acronym / sponsor ID
- TRUS-BX / 2017-KAEK-189_2021.05.05_08
- Conditions
- Prostate Neoplasms, Prostate Biopsy
- Keywords
- prostate biopsy, music, conversation, anxiety, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music intervention | Experimental | Behavioral: Music interventionThe patients who listened to music during procedure |
| Conversation | Experimental | Behavioral: ConversationThe patients who were involved into conversation during procedure |
| Control | No intervention | –The patients who were not involved into conversation or listened to music during procedure |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- pathological findings on Digital Rectal Examination
- PSA value greater than 2.5 ng/ml
Key exclusion criteria (6 listed)
- psychiatric disorders,
- those who declined to participate,
- hearing or perceptual impairments,
- continuous analgesic use,
- history of prior prostate biopsy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionAlso: ConversationEngaging into conversation during procedure | Behavioural | Music intervention |
| ConversationEngaging patients into conversation | Behavioural | Conversation |
Primary outcome
Visual Analog Scale of Pain
Time frame: Periprocedural
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
Visual Analog Scale of Anxiety
Time frame: Periprocedural
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
State-Trait Anxiety Inventory (STAI) test
Time frame: Periprocedural
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Results publication: PubMed 26929606Chiu 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.
- Results publication: PubMed 27085561Cho 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.
- Results publication: PubMed 25531837Chang 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.
- Derived from this study: PubMed 41417393Selmi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
volkan selmi principal investigator
Yozgat Bozok University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention and Conversation in people with Prostate Neoplasms and Prostate Biopsy, run by Bozok University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale of Pain (time frame: Periprocedural). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07006779, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.