Rectal ice to reduce pain and anxiety during transrectal 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

This tests whether placing ice in the rectum during a transrectal prostate biopsy reduces pain, anxiety, and cortisol levels in men having their first TRUS-guided biopsy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Mersin University (Academic / other)
• Locations: 2 sites (Mersin and 1 other locations)
• Trial ID: NCT06998121 on ClinicalTrials.gov

What this trial studies

Men scheduled for their first transrectal ultrasound (TRUS)-guided prostate biopsy will receive intrarectal ice application immediately before or during the procedure. Pain and anxiety will be measured with validated scales and blood cortisol will be sampled to quantify the stress response, while investigators will monitor for biopsy-related complications such as bleeding, infection, and urinary retention. Outcomes in participants receiving intrarectal ice will be compared with standard care to determine effects on pain, anxiety, cortisol, analgesic needs, and complication rates. The trial is conducted at Mersin University with local follow-up for complication monitoring.

Who should consider this trial

Good fit: Men aged 18 or older scheduled for their first TRUS-guided prostate biopsy who are conscious, oriented, able to communicate, and not diagnosed with or treated for anxiety or other mental disorders.

Not a fit: Patients who have had prior prostate biopsies, who are taking medications for anxiety, who have diagnosed anxiety or other mental disorders, or who have rectal conditions that make intrarectal cooling unsafe are unlikely to benefit.

Why it matters

Potential benefit: If successful, this simple, low-cost technique could reduce procedural pain and anxiety, lower cortisol responses, and potentially decrease biopsy-related complications and need for pain medications.

How similar studies have performed: Non-drug approaches like topical anesthesia and local cooling have shown some benefit for procedural pain in prior research, but intrarectal ice specifically for TRUS biopsy is relatively novel with limited prior evidence.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients who refuse to participate in the study,
* Patients under the age of 18
* Patients who are conscious, oriented, and 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.

Where this trial is running

Mersin and 1 other locations

• Mersin Unıversıty — Mersin, Turkey (Türkiye) (Recruiting)
• Mersin Unıversıty — Mersin, Turkey (Türkiye) (Recruiting)

Study contacts

• Principal investigator: Gamze Bozkul — Tarsus University
• Study coordinator: Eli̇fe Kettaş Dölek

Conditions Prostate Cancer; Transrectal ultrasound-guided prostate biopsy; intrarectal ice application; pain, anxiety, cortisol levels