Pain and Anxiety During Transrectal Prostate Biopsy

Comparison of the Effects of Music and Tens Application on Patient's Perception on Pain and Anxiety During Transrectal Prostate Biopsy

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Biopsy
• Intervention / Treatment: Other: Music; Device: TENS

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

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reha Girgin, Assist.Prof.; Phone Number: 05378865912; Email: mujdereha7477@hotmail.com
• Study Contact Backup: Name: Onur ÖZYAMAN, MD; Phone Number: 05530119550; Email: dr.ozyaman@gmail.com

Study Locations

• Turkey
  • Zonguldak, Turkey
    • Recruiting
    • Zonguldak Bülent Ecevit University
    • Contact: Reha Girgin, Assist.Prof.; Phone Number: 05378865912; Email: mujdereha7477@hotmail.com
    • Contact: Onur ÖZYAMAN, MD; Phone Number: 05530119550; Email: dr.ozyaman@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Prostatic block; Patients who will be treated with periprostatic block
Active Comparator: Prostatic block+Music; Patients who will be treated with periprostatic block and who will be simultaneously listened to music	Other: Music; A standard music determined by us for the 1st and 4th groups will be played during the process.
Active Comparator: Prostatic block+Tens; Patients who will undergo periprostatic block and concomitant TENS	Device: TENS; TENS device will be connected to the 3rd and 5th groups during the process and the process will be done in this way.
Active Comparator: Music; Patients who will only listen to music without periprostatic block	Other: Music; A standard music determined by us for the 1st and 4th groups will be played during the process.
Active Comparator: Tens; Patients who will only be treated with TENS without periprostatic block	Device: TENS; TENS device will be connected to the 3rd and 5th groups during the process and the process will be done in this way.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain during procedure	VAS (visual analog scale) will be used for pain evaluation. A scale rating from 0 (no pain) to 10 (most painful).	during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anxiety related to procedure	STAI (The State-Trait Anxiety Inventory) will be used for anxiety evaluation. The STAI consists of 40 items, 20 for each subscale. Items are rated on a Likert scale from 1 (not at all/almost never) to 4 (very much so/almost always), and some items are reverse-scored.	during the procedure

Collaborators and Investigators

• Sponsor: Zonguldak Bulent Ecevit University
• Investigators: Study Director: Reha GİRGİN, Assist.Prof., Zonguldak Bülent Ecevit University

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Anticipated): March 14, 2023
• Study Completion (Anticipated): March 14, 2023

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: pain; music; transcutaneous electrical stimulation; periprostatic block
• Other Study ID Numbers: OR-9374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No