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
- Diseases
- Prostate cancer
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mersin Unıversıty Coordinator of this site? Confirm its status | Mersin | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.