Comparison of the Effects of Music and Tens Application on Patient's Perception on Pain and Anxiety During Transrectal Prostate Biopsy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- pain during procedure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
Due to the design of the study, it is not possible for patients and specialists to be blinded.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- anxiety related to procedure(during the procedure)
Investigators
Reha Girgin
Assist.Prof.Dr..
Zonguldak Bulent Ecevit University