Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05358223 |
Other study ID # |
OR-9374 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 14, 2022 |
Est. completion date |
March 14, 2023 |
Study information
Verified date |
April 2022 |
Source |
Zonguldak Bulent Ecevit University |
Contact |
Reha GIRGIN, Assist.Prof. |
Phone |
05378865912 |
Email |
mujdereha7477[@]hotmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 applications will make an additional
contribution.However, there is no study comparing the effect of TENS and music.
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