Pain and Anxiety During Transrectal Prostate Biopsy

Zonguldak Bulent Ecevit University

Status: Unknown

Conditions: Prostate Biopsy

Treatments: Other: Music; Device: TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT05358223

OR-9374

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 5 patient groups

Prostatic block

No Intervention group

Description:

Patients who will be treated with periprostatic block

Prostatic block+Music

Active Comparator group

Description:

Patients who will be treated with periprostatic block and who will be simultaneously listened to music

Treatment:

Other: Music

Prostatic block+Tens

Active Comparator group

Description:

Patients who will undergo periprostatic block and concomitant TENS

Treatment:

Device: TENS

Music

Active Comparator group

Description:

Patients who will only listen to music without periprostatic block

Treatment:

Other: Music

Tens

Active Comparator group

Description:

Patients who will only be treated with TENS without periprostatic block

Treatment:

Device: TENS