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NCT06998121Completed

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

The Effect of Intrarectal Ice Application on Pain, Anxiety, Cortisol Level, Complication Development and Re-admission to Hospital in Transrectal Ultrasonography Guided Prostate Biopsy

Source: ClinicalTrials.gov · Last updated 12 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
84 (actual)
First submitted
29 May 2025
Start date
1 Dec 2025
Primary completion date
15 Apr 2026
Lead sponsor
Mersin University
NCT number
NCT06998121

What you commit to

  • Study type: Interventional
  • Participants enrolled: 84
  • From 1 Dec 2025 to the primary completion date, 15 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have previously undergone prostate biopsy,
  • Patients taking medication for anxiety control.

Other illness

  • Patients with mental disorders,
  • Patients diagnosed with anxiety disorder,

Age

  • Patients under the age of 18

Other

  • Patients who refuse to participate in the study,
  • Patients who are conscious, oriented, and uncooperative,
  • Patients with communication problems,
  • Patients who have not undergone transrectal ultrasound-guided prostate biopsy,

Who the study is looking for

  • 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 who are scheduled to undergo their first prostate biopsy under transrectal ultrasound guidance,
  • Patients who have no mental disorders,
  • Patients who have not been diagnosed with anxiety disorder,
  • Patients not taking medication for anxiety control.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mersin Unıversıty
Coordinator of this site? Confirm its status
MersinTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.