Clinical trial NCT05358223: Pain and Anxiety During Transrectal Prostate Biopsy
Official title: Comparison of the Effects of Music and Tens Application on Patient's Perception on Pain and Anxiety During Transrectal Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Biopsy
Keywords: pain
periprostatic block
transcutaneous electrical stimulation
music
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients with acute prostatitis
* Neutropenic patients
* Patients with bleeding diathesis that interferes with the procedure
* Patients without consent to participate in the study

Primary outcomes:
measure: pain during procedure
timeFrame: during the procedure
Secondary outcomes:
measure: anxiety related to procedure
timeFrame: during the procedure
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bulent Ecevit University
Study officials:
affiliation: Zonguldak Bulent Ecevit University
name: Reha GİRGİN, Assist.Prof.
role: STUDY_DIRECTOR
References: