Study Results
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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UNKNOWN
NA
150 participants
INTERVENTIONAL
2022-03-14
2023-03-14
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Prostatic block
Patients who will be treated with periprostatic block
No interventions assigned to this group
Prostatic block+Music
Patients who will be treated with periprostatic block and who will be simultaneously listened to music
Music
A standard music determined by us for the 1st and 4th groups will be played during the process.
Prostatic block+Tens
Patients who will undergo periprostatic block and concomitant TENS
TENS
TENS device will be connected to the 3rd and 5th groups during the process and the process will be done in this way.
Music
Patients who will only listen to music without periprostatic block
Music
A standard music determined by us for the 1st and 4th groups will be played during the process.
Tens
Patients who will only be treated with TENS without periprostatic block
TENS
TENS device will be connected to the 3rd and 5th groups during the process and the process will be done in this way.
Interventions
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Music
A standard music determined by us for the 1st and 4th groups will be played during the process.
TENS
TENS device will be connected to the 3rd and 5th groups during the process and the process will be done in this way.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Neutropenic patients
* Patients with bleeding diathesis that interferes with the procedure
* Patients without consent to participate in the study
18 Years
MALE
No
Sponsors
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Zonguldak Bulent Ecevit University
OTHER
Responsible Party
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Reha Girgin
Assist.Prof.Dr..
Principal Investigators
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Reha GİRGİN, Assist.Prof.
Role: STUDY_DIRECTOR
Zonguldak Bulent Ecevit University
Locations
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Zonguldak Bulent Ecevit University
Zonguldak, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OR-9374
Identifier Type: -
Identifier Source: org_study_id
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