Pain and Anxiety During Transrectal Prostate Biopsy

NCT05358223 | Unknown

• 1 other identifier: OR-9374
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Biopsy

Keywords

pain; periprostatic block; transcutaneous electrical stimulation; music

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• anxiety related to procedure

  during the procedure

Study Arms (5)

Prostatic block

NO INTERVENTION

Patients who will be treated with periprostatic block

Prostatic block+Music

ACTIVE COMPARATOR

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

Other: Music

Prostatic block+Tens

ACTIVE COMPARATOR

Patients who will undergo periprostatic block and concomitant TENS

Device: TENS

Music

ACTIVE COMPARATOR

Patients who will only listen to music without periprostatic block

Other: Music

Tens

ACTIVE COMPARATOR

Patients who will only be treated with TENS without periprostatic block

Device: TENS

Interventions

Music OTHER

A standard music determined by us for the 1st and 4th groups will be played during the process.

Music; Prostatic block+Music

TENS DEVICE

TENS device will be connected to the 3rd and 5th groups during the process and the process will be done in this way.

Prostatic block+Tens; Tens

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bulent Ecevit University

Zonguldak, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Music Therapy; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Physical Therapy Modalities; Analgesia; Anesthesia and Analgesia

Study Officials

• Reha GİRGİN, Assist.Prof.

  Zonguldak Bulent Ecevit University

  STUDY DIRECTOR

Central Study Contacts

Reha GİRGİN, Assist.Prof.

CONTACT

05378865912; mujdereha7477@hotmail.com

Onur ÖZYAMAN, MD

CONTACT

05530119550; dr.ozyaman@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the design of the study, it is not possible for patients and specialists to be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist.Prof.Dr..

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 3, 2022
• Study Start: March 14, 2022
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)