PainNCT04466202
Effectiveness of the Music With Structured Verbal Training During Prostate Biopsy
A study testing Music with Structured Verbal Training in people with Pain and Anxiety, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Transrectal ultrasound (TRUS) guided prostate biopsy is a gold standard method widely used in the diagnosis of prostate cancer. This procedure can be very painful and anxious for men. Various pharmacological methods can be used to relieve patients' pain and discomfort during TRUS-guided prostate biopsy. Read more about this study
- Who is it for?
- Ages 40 to 86 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Anxiety, Satisfaction
- What is being tested?
- Music with Structured Verbal Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jan 2020to 31 Dec 2020
- 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 40 to 86 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being over the age of 40
- male gender
- transrectal ultrasound guided prostate biopsy for the first time
- agreeing to participate in the study
Who cannot join
- presence of any contraindication for prostate biopsy
- any analgesic used 24 hours before prostate biopsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Music With Structured Verbal Training on Pain, Anxiety and Satisfaction During Prostate Biopsy
Transrectal ultrasound (TRUS) guided prostate biopsy is a gold standard method widely used in the diagnosis of prostate cancer. This procedure can be very painful and anxious for men. Various pharmacological methods can be used to relieve patients' pain and discomfort during TRUS-guided prostate biopsy. Although there is still no consensus on the solution suggestions for pain and anxiety due to biopsy, it is known that music, which is a non-pharmacological method, is effective in this regard. The aim of this study is to evaluate the effect of music with structured verbal training on patients' pain, anxiety and satisfaction levels during transrectal ultrasound-guided prostate biopsy.
Read the detailed description
Although there have been several studies examining the effect of music on pain and / or anxiety during TRUS prostate biopsy, only one study has been found examining the effect of stress management (music and one-to-one simulation training) on patients' pain and anxiety levels. In addition, there is only one study on the effectiveness of the training method (written and video-based training) on anxiety levels of patients related to prostate biopsy. For this reason, it is thought that music will be more effective on pain and anxiety levels along with structured verbal training to alleviate the discomfort associated with patients' biopsy procedure.
- Conditions
- Pain, Anxiety, Satisfaction, Urological Nursing
- Being tested
- Music with Structured Verbal Training
- Keywords
- Anxiety, Nursing, Pain, Satisfaction, Prostate biopsy
- Medical subject headings
- Pain, Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music with Structured Verbal TrainingOther
Structured verbal training on prostate biopsy was given to the intervention group before the procedure, and then patients in this group listened to the music they preferred during the procedure with headphones.
| Study group | Role | What they receive |
|---|---|---|
| Music Group with Structured Verbal Training | Experimental | Music with structured verbal training was applied during transrectal ultrasound guided prostate biopsy. Receives: Other: Music with Structured Verbal Training |
| Control Group | No intervention | The control group did not listen to music during the procedure, and they received routine training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change on pain intensity as measured by Visual Analog Scale
The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm (0-100 mm). High scores on the scale indicate that pain intensity is high.
Measured: "just before procedure", "during procedure" and "5 minutes after procedure"
Secondary outcomes (1)
score change on anxiety level as measured by State-Trait Anxiety Inventory
The average score change on anxiety level as measured by State-Trait Anxiety Inventory. This scale is used to measure anxiety. The scores on the scale ranges from 20 to 80. The high scores on the scale indicate that anxiety is high.
Measured: "just before procedure" and "5 minutes after procedure"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start22 Jan 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: The study was terminated prematurely due to the dissolution of the research collaboration, which prevented the completion of the protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Gezginci Akpinar, Saglik Bilimleri Universitesi
- Investigators
- Elif Gezginci, PhD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466202
- Sponsor's protocol ID
- 2020.02.13-07
- Status last verified
- Sep 2026
- First submitted
- 6 Jul 2020
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
PubMed 11733293Chang 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 25531837Chiu 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 27085561Chopra S, Rowe EW, Laniado M, Patel A. A prospective study analysing the effect of pain on probe insertion, and the biopsy strategy, on the patients' perception of pain during TRUS-guided biopsy of the prostate. N Z Med J. 2008 Dec 12;121(1287):39-43.
PubMed 19098966Packiam VT, Nottingham CU, Cohen AJ, Eggener SE, Gerber GS. No Effect of Music on Anxiety and Pain During Transrectal Prostate Biopsies: A Randomized Trial. Urology. 2018 Jul;117:31-35. doi: 10.1016/j.urology.2018.04.014. Epub 2018 Apr 27.
PubMed 29709434Tsivian M, Qi P, Kimura M, Chen VH, Chen SH, Gan TJ, Polascik TJ. The effect of noise-cancelling headphones or music on pain perception and anxiety in men undergoing transrectal prostate biopsy. Urology. 2012 Jan;79(1):32-6. doi: 10.1016/j.urology.2011.09.037.
PubMed 22202544
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music With Structured Verbal Training on Pain, Anxiety and Satisfaction During Prostate Biopsy
- ClinicalTrials.gov ID
- NCT04466202
- Acronym / sponsor ID
- 2020.02.13-07
- Conditions
- Pain, Anxiety, Satisfaction, Urological Nursing
- Keywords
- Anxiety, Nursing, Pain, Satisfaction, Prostate biopsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely due to the dissolution of the research collaboration, which prevented the completion of the protocol.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 10 Jul 2020 (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.
Transrectal ultrasound (TRUS) guided prostate biopsy is a gold standard method widely used in the diagnosis of prostate cancer. This procedure can be very painful and anxious for men. Various pharmacological methods can be used to relieve patients' pain and discomfort during TRUS-guided prostate biopsy. Although there is still no consensus on the solution suggestions for pain and anxiety due to biopsy, it is known that music, which is a non-pharmacological method, is effective in this regard. The aim of this study is to evaluate the effect of music with structured verbal training on patients' pain, anxiety and satisfaction levels during transrectal ultrasound-guided prostate biopsy.
Detailed description
Although there have been several studies examining the effect of music on pain and / or anxiety during TRUS prostate biopsy, only one study has been found examining the effect of stress management (music and one-to-one simulation training) on patients' pain and anxiety levels. In addition, there is only one study on the effectiveness of the training method (written and video-based training) on anxiety levels of patients related to prostate biopsy. For this reason, it is thought that music will be more effective on pain and anxiety levels along with structured verbal training to alleviate the discomfort associated with patients' biopsy procedure.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Group with Structured Verbal Training | Experimental | Other: Music with Structured Verbal TrainingMusic with structured verbal training was applied during transrectal ultrasound guided prostate biopsy. |
| Control Group | No intervention | –The control group did not listen to music during the procedure, and they received routine training. |
Who may qualify
- Ages
- 40 to 86 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being over the age of 40
- male gender
- transrectal ultrasound guided prostate biopsy for the first time
- agreeing to participate in the study
Key exclusion criteria (2 listed)
- presence of any contraindication for prostate biopsy
- any analgesic used 24 hours before 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 with Structured Verbal TrainingStructured verbal training on prostate biopsy was given to the intervention group before the procedure, and then patients in this group listened to the music they preferred during the procedure with headphones. | Other | Music Group with Structured Verbal Training |
Primary outcome
change on pain intensity as measured by Visual Analog Scale
Time frame: "just before procedure", "during procedure" and "5 minutes after procedure"
The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm (0-100 mm). High scores on the scale indicate that pain intensity is high.
1 secondary outcome
score change on anxiety level as measured by State-Trait Anxiety Inventory
Time frame: "just before procedure" and "5 minutes after procedure"
Results and safety
The study was stopped early (reason given: The study was terminated prematurely due to the dissolution of the research collaboration, which prevented the completion of the protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 11733293Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: PubMed 19098966Chopra S, Rowe EW, Laniado M, Patel A. A prospective study analysing the effect of pain on probe insertion, and the biopsy strategy, on the patients' perception of pain during TRUS-guided biopsy of the prostate. N Z Med J. 2008 Dec 12;121(1287):39-43.
- Background: PubMed 29709434Packiam VT, Nottingham CU, Cohen AJ, Eggener SE, Gerber GS. No Effect of Music on Anxiety and Pain During Transrectal Prostate Biopsies: A Randomized Trial. Urology. 2018 Jul;117:31-35. doi: 10.1016/j.urology.2018.04.014. Epub 2018 Apr 27.
- Background: PubMed 22202544Tsivian M, Qi P, Kimura M, Chen VH, Chen SH, Gan TJ, Polascik TJ. The effect of noise-cancelling headphones or music on pain perception and anxiety in men undergoing transrectal prostate biopsy. Urology. 2012 Jan;79(1):32-6. doi: 10.1016/j.urology.2011.09.037.
- Individual participant dataSharing planned: No
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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.
Elif Gezginci, PhD principal investigator
Saglik Bilimleri Universitesi
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 with Structured Verbal Training in people with Pain and Anxiety, run by Saglik Bilimleri Universitesi 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 2 Oct 2026. 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 was stopped early (reason given: The study was terminated prematurely due to the dissolution of the research collaboration, which prevented the completion of the protocol.). Results are not available in the source record.
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?
change on pain intensity as measured by Visual Analog Scale (time frame: "just before procedure", "during procedure" and "5 minutes after procedure"). 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 NCT04466202, which also lists 7 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 2 Oct 2026.