Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06998121

The Effect of Intrarectal Ice Application on Pain, Anxiety, Cortisol Level, Complication Development in Transrectal Ultrasonography Guided Prostate Biopsy

Led by Mersin University · Updated on 2026-03-24

84

Participants Needed

2

Research Sites

49 weeks

Total Duration

On this page

Sponsors

M

Mersin University

Lead Sponsor

T

Tarsus University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Transrectal ultrasound (TRUS)-guided prostate biopsy is one of the most commonly performed urological procedures today. This technique involves the insertion of a needle through the rectal mucosa to access the prostate. While TRUS-guided biopsy demonstrates a high detection rate for prostate cancer, it also carries a significant risk of post-procedural complications, such as hematuria, rectal bleeding, urinary retention, and anemia. Compared to other biopsy methods, TRUS-guided biopsy is associated with higher rates of hospital readmissions and an increased risk of infection and sepsis. These complications contribute to elevated healthcare costs, prolonged hospital stays, increased workload for healthcare providers, heightened patient stress and anxiety levels, greater analgesic requirements, the potential for additional complications, and reduced patient satisfaction. Various non-pharmacological methods have been shown to be effective in preventing these adverse patient outcomes. One such method, which has been identified in the literature as effective, is cold application. Cold application is a widely preferred non-pharmacological intervention due to its simplicity, affordability, and accessibility. It is particularly used to reduce acute pain, edema, and bleeding. Cold therapy slows down metabolism, thereby reducing the oxygen and nutrient demands of tissues; it also limits inflammation, muscle spasm, and edema, alleviates pressure and tension on nerve endings, and decreases the conduction velocity of peripheral nerves. These effects contribute to a reduction in patients' pain, anxiety associated with pain, and bleeding. The aim of this study is to determine the effects of intrarectal ice application during transrectal ultrasound-guided prostate biopsy on pain, anxiety, cortisol levels, the incidence of complications, and hospital readmission rates.

CONDITIONS

Official Title

The Effect of Intrarectal Ice Application on Pain, Anxiety, Cortisol Level, Complication Development in Transrectal Ultrasonography Guided Prostate Biopsy

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who agree to participate in the study
  • Patients over the age of 18
  • Patients who are conscious, oriented, and cooperative
  • Patients who have no communication problems
  • Patients scheduled for their first transrectal ultrasound-guided prostate biopsy
  • Patients without mental disorders
  • Patients not diagnosed with anxiety disorder
  • Patients not taking medication for anxiety control
Not Eligible

You will not qualify if you...

  • Patients who refuse to participate in the study
  • Patients under the age of 18
  • Patients who are conscious, oriented, but uncooperative
  • Patients with communication problems
  • Patients who have not undergone transrectal ultrasound-guided prostate biopsy
  • Patients who have previously undergone prostate biopsy
  • Patients with mental disorders
  • Patients diagnosed with anxiety disorder
  • Patients taking medication for anxiety control

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Mersin Unıversıty

Mersin, Turkey (Türkiye)

Actively Recruiting

2

Mersin Unıversıty

Mersin, Turkey (Türkiye)

Actively Recruiting

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Research Team

E

ELİFE KETTAŞ DÖLEK

CONTACT

E

ELİFE KETTAŞ DÖLEK

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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