Prostate BiopsyNCT05358223
Pain and Anxiety During Transrectal Prostate Biopsy
A study testing Music and TENS in people with Prostate Biopsy, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
Many studies have been conducted in the literature to manage pain and anxiety levels for patients undergoing transrectal prostate biopsy. In addition to the periprostatic block application recommended in the guidelines of the European Association of Urology, there are studies showing that TENS application or music… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Biopsy
- What is being tested?
- Music and TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2022to 14 Mar 2023
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 50 with high psa
- Patients with a family history of psa elevation over the age of 45
- psa > 10 ng/ml
- Patients with abnormal prostate examination
- Patients with psa 4-10 who need prostate biopsy
- Presence of PIRAD-4 and 5 lesions in multiparametric MR imaging
- Patients with consent to participate in the study
Who cannot join
- Patients with acute prostatitis
- Neutropenic patients
- Patients with bleeding diathesis that interferes with the procedure
- Patients without consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zonguldak Bulent Ecevit University
Zonguldak
Reha GİRGİN, Assist.Prof., 05378865912, mujdereha7477@hotmail.com
Onur ÖZYAMAN, MD, 05530119550, dr.ozyaman@gmail.com
About this study
Official title: Comparison of the Effects of Music and Tens Application on Patient's Perception on Pain and Anxiety During Transrectal Prostate Biopsy
Many studies have been conducted in the literature to manage pain and anxiety levels for patients undergoing transrectal prostate biopsy. In addition to the periprostatic block application recommended in the guidelines of the European Association of Urology, there are studies showing that TENS application or music applications will make an additional contribution.However, there is no study comparing the effect of TENS and music.
Read the detailed description
Patients who applied to the urology outpatient clinic and whose prostate biopsy decision was made in accordance with the criteria specified in the guidelines of the European urology society will be randomized into 5 groups.
group 1: will apply only periprostatic block group 2: patients who will undergo periprostatic block + listen to music group 3 : patients to whom periprostatic block will be applied + tens device will be applied group 4 : patients who will only listen to music group 5 : patients who will only be treated with tens
A standard music determined by us for the 1st and 4th groups will be played during the process.
TENS device will be connected to the 3rd and 5th groups during the process and the process will be done in this way.
In our study, a 2-channel TENS device will be used. One of the electrodes connected to the first channel will be placed in the right anterior suprapubic region and the other in the right posterior presacral area. The electrodes connected to the second channel will be placed in the left anterior suprapubic region and left posterior presacral region, similar to the other. At least 3-6 minutes before the biopsy, stimulation will be started from the lower energy rising to 60 milliamperes with a frequency of 100 Hz and a pulse width of 150 µs. the amplitude will be adjusted individually for each participant to a level they can tolerate.
The blood pressure, pulse, respiratory rate and spo2 values of the patients are measured at the beginning, middle and end of the procedure and recorded. In our study, these data will be used by obtaining from the files of the patients.
In all groups, at the beginning, middle and end of the prostate biopsy procedure, an evaluation will be made with a visual analog score to evaluate the pain status of the patients.
Anxiety levels will be calculated with the state-continuity and anxiety scale that will be given to the patients the day before the procedure in all groups. After the prostate biopsy procedure is completed, this scale will be given to the patients again and their anxiety status will be re-evaluated after the procedure.
All the obtained data will be compared between these five groups and it will be tried to determine the optimal method in the pain and anxiety management of the patients.
Parameters to be used in the research:
- total psa , free psa , hemogram , urea, creatinine, total testosterone.
- International prostate symptom score ( IPSS ) and international erectile function index (IIEF- 5) score of 5 questions
- Visual analog pain score and state-continuity and anxiety scale scale
- Patients' blood pressure, fever, pulse and spo2 values
- Conditions
- Prostate Biopsy
- Being tested
- Music, TENS
- Keywords
- pain, periprostatic block, transcutaneous electrical stimulation, music
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
A standard music determined by us for the 1st and 4th groups will be played during the process.
TENSDevice
TENS device will be connected to the 3rd and 5th groups during the process and the process will be done in this way.
| Study group | Role | What they receive |
|---|---|---|
| Prostatic block | No intervention | Patients who will be treated with periprostatic block |
| Prostatic block+Music | Active comparator | Patients who will be treated with periprostatic block and who will be simultaneously listened to music Receives: Other: Music |
| Prostatic block+Tens | Active comparator | Patients who will undergo periprostatic block and concomitant TENS Receives: Device: TENS |
| Music | Active comparator | Patients who will only listen to music without periprostatic block Receives: Other: Music |
| Tens | Active comparator | Patients who will only be treated with TENS without periprostatic block Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain during procedure
VAS (visual analog scale) will be used for pain evaluation. A scale rating from 0 (no pain) to 10 (most painful).
Measured: during the procedure
Secondary outcomes (1)
anxiety related to procedure
STAI (The State-Trait Anxiety Inventory) will be used for anxiety evaluation. The STAI consists of 40 items, 20 for each subscale. Items are rated on a Likert scale from 1 (not at all/almost never) to 4 (very much so/almost always), and some items are reverse-scored.
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start14 Mar 2022
- Primary completion14 Mar 2023 (estimated)
- Study completion14 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate BiopsyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who applied to the urology outpatient clinic and whose prostate biopsy decision was made according to the criteria specified in the guidelines of the European Urology Society, firstly detailed information about the study will be given after excluding those who were not suitable for the study, and then they will be randomly divided into 5 groups with the help of a computer program.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reha Girgin, Zonguldak Bulent Ecevit University
- Investigators
- Reha GİRGİN, Assist.Prof., Study director, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358223
- Sponsor's protocol ID
- OR-9374
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Music and Tens Application on Patient's Perception on Pain and Anxiety During Transrectal Prostate Biopsy
- ClinicalTrials.gov ID
- NCT05358223
- Acronym / sponsor ID
- OR-9374
- Conditions
- Prostate Biopsy
- Keywords
- pain, periprostatic block, transcutaneous electrical stimulation, music
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 14 Mar 2023 (estimated)
- Study completion
- 14 Mar 2023 (estimated)
- First posted
- 3 May 2022 (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.
Many studies have been conducted in the literature to manage pain and anxiety levels for patients undergoing transrectal prostate biopsy. In addition to the periprostatic block application recommended in the guidelines of the European Association of Urology, there are studies showing that TENS application or music applications will make an additional contribution.However, there is no study comparing the effect of TENS and music.
Detailed description
Patients who applied to the urology outpatient clinic and whose prostate biopsy decision was made in accordance with the criteria specified in the guidelines of the European urology society will be randomized into 5 groups.
group 1: will apply only periprostatic block group 2: patients who will undergo periprostatic block + listen to music group 3 : patients to whom periprostatic block will be applied + tens device will be applied group 4 : patients who will only listen to music group 5 : patients who will only be treated with tens
A standard music determined by us for the 1st and 4th groups will be played during the process.
TENS device will be connected to the 3rd and 5th groups during the process and the process will be done in this way.
In our study, a 2-channel TENS device will be used. One of the electrodes connected to the first channel will be placed in the right anterior suprapubic region and the other in the right posterior presacral area. The electrodes connected to the second channel will be placed in the left anterior suprapubic region and left posterior presacral region, similar to the other. At least 3-6 minutes before the biopsy, stimulation will be started from the lower energy rising to 60 milliamperes with a frequency of 100 Hz and a pulse width of 150 µs. the amplitude will be adjusted individually for each participant to a level they can tolerate.
The blood pressure, pulse, respiratory rate and spo2 values of the patients are measured at the beginning, middle and end of the procedure and recorded. In our study, these data will be used by obtaining from the files of the patients.
In all groups, at the beginning, middle and end of the prostate biopsy procedure, an evaluation will be made with a visual analog score to evaluate the pain status of the patients.
Anxiety levels will be calculated with the state-continuity and anxiety scale that will be given to the patients the day before the procedure in all groups. After the prostate biopsy procedure is completed, this scale will be given to the patients again and their anxiety status will be re-evaluated after the procedure.
All the obtained data will be compared between these five groups and it will be tried to determine the optimal method in the pain and anxiety management of the patients.
Parameters to be used in the research:
- total psa , free psa , hemogram , urea, creatinine, total testosterone.
- International prostate symptom score ( IPSS ) and international erectile function index (IIEF- 5) score of 5 questions
- Visual analog pain score and state-continuity and anxiety scale scale
- Patients' blood pressure, fever, pulse and spo2 values
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Patients who applied to the urology outpatient clinic and whose prostate biopsy decision was made according to the criteria specified in the guidelines of the European Urology Society, firstly detailed information about the study will be given after excluding those who were not suitable for the study, and then they will be randomly divided into 5 groups with the help of a computer program.
| Arm | Type | Receives |
|---|---|---|
| Prostatic block | No intervention | –Patients who will be treated with periprostatic block |
| Prostatic block+Music | Active comparator | Other: MusicPatients who will be treated with periprostatic block and who will be simultaneously listened to music |
| Prostatic block+Tens | Active comparator | Device: TENSPatients who will undergo periprostatic block and concomitant TENS |
| Music | Active comparator | Other: MusicPatients who will only listen to music without periprostatic block |
| Tens | Active comparator | Device: TENSPatients who will only be treated with TENS without periprostatic block |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients over 50 with high psa
- Patients with a family history of psa elevation over the age of 45
- psa > 10 ng/ml
- Patients with abnormal prostate examination
- Patients with psa 4-10 who need prostate biopsy
Key exclusion criteria (4 listed)
- Patients with acute prostatitis
- Neutropenic patients
- Patients with bleeding diathesis that interferes with the procedure
- Patients without consent to participate in the study
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 |
|---|---|---|
| MusicA standard music determined by us for the 1st and 4th groups will be played during the process. | Other | Music, Prostatic block+Music |
| TENSTENS device will be connected to the 3rd and 5th groups during the process and the process will be done in this way. | Device | Prostatic block+Tens, Tens |
Primary outcome
pain during procedure
Time frame: during the procedure
VAS (visual analog scale) will be used for pain evaluation. A scale rating from 0 (no pain) to 10 (most painful).
1 secondary outcome
anxiety related to procedure
Time frame: during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- 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.
Reha GİRGİN, Assist.Prof. study director
Zonguldak Bulent Ecevit 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 and TENS in people with Prostate Biopsy, run by Zonguldak Bulent Ecevit 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reha GİRGİN, Assist.Prof. (05378865912, mujdereha7477@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain during procedure (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2022.