Effect of Intrarectal Ice Application on Pain, Anxiety, Cortisol Levels, Development of Complications, and Hospital Readmission in Transrectal Ultrasound-Guided Prostate Biopsy

Summary

The aim of this study is to determine the effect of intrarectal ice application on pain, anxiety, cortisol levels, development of complications (rectal bleeding, hematuria, urinary retention, anemia, infection, etc.), and hospital readmission in patients undergoing transrectal ultrasound-guided prostate biopsy. This randomized controlled clinical trial will include patients who apply to the Urology Outpatient Clinic of Mersin University Hospital and are scheduled to undergo transrectal ultrasound-guided prostate biopsy. Since the necessary data for sample size calculation (mean values were provided but standard deviation values were not reported) could not be obtained from the reference study by Çalışkan and Mutlu (2015), the sample size was calculated based on an effect size of 0.8. With an effect size of d = 0.8 and 95% power (1-α, two-tailed), the minimum sample size was calculated as 84 patients (42 in the intervention group and 42 in the control group) using the G\*Power (3.1) program. The primary outcomes of the study are the effects of intrarectal ice application on pain, anxiety, and cortisol levels. The secondary outcomes are the development of complications and hospital readmission. Research data will be collected between June and December 2025 using the "Descriptive Information Form," the "State Anxiety Scale," the "Visual Analog Scale," and the "Patient Follow-up Form." In addition to the routine treatment and care practices of the outpatient clinic, patients in the intervention group will receive intrarectal ice application performed by the researchers (E.K.D. and M.B.). For each patient, a new size 8 glove will be used; the middle finger of the glove will be filled with water and frozen to obtain the cold application material. Immediately before the procedure, the ice-lubricated with gel-will be inserted into the patient's rectum and kept in place for 5 minutes . All patients' pain and anxiety levels will be evaluated during and after the procedure. At the end of the prostate biopsy, an additional 2 ml blood sample will be collected to measure serum cortisol levels. The development of complications will be assessed during the procedure and one week later via telephone follow-up conducted by the researchers (E.K.D. and G.B.). During the telephone call one week later, patients will also be asked whether they have been readmitted to the hospital within that period. All information will be recorded in the relevant forms. In the control group, routine treatment and care procedures of the outpatient clinic will be applied. In the clinic where the study is conducted, oral antibiotic therapy (Iesef 1 g, twice daily) is initiated 24 hours before the prostate biopsy and continued until the prescribed course is completed. B.T. enema is administered the night before the procedure and at 06:00 on the morning of the procedure. During the procedure, biopsy samples are taken from 12 different regions using a fine needle under transrectal ultrasound guidance. After the procedure, patients experiencing pain are advised that they may take oral analgesics (paracetamol). In addition, patients are informed about post-procedure precautions (e.g., to seek medical attention in cases of fever ≥38.5°C or severe hematuria, to avoid spicy foods for two weeks, etc.). No specific intervention is performed in the outpatient clinic to control patients' pain or anxiety during prostate biopsy. Patients in the control group will receive only these routine treatments and care practices.

Conditions

• TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY

Interventions

OTHER

Intrarectal ıce

In addition to the routine treatment and care practices of the outpatient clinic, patients in the intervention group will receive intrarectal ice application performed by the researchers (E.K.D. and M.B.). For each patient, a new size 8 glove will be used; the middle finger of the glove will be filled with water and frozen to obtain the cold application material. Immediately before the procedure, the ice-lubricated with gel-will be inserted into the patient's rectum and kept in place for 5 minutes (Çalışkan \& Mutlu, 2015). All patients' pain and anxiety levels will be evaluated during and after the procedure. At the end of the prostate biopsy, an additional 2 ml blood sample will be collected to measure serum cortisol levels. The development of complications will be assessed during the procedure and one week later via telephone follow-up conducted by the researchers (E.K.D. and G.B.). During the telephone call one week later, patients will also be asked whether they have been readmitt

Sponsors & Collaborators

• Tarsus University

  lead OTHER

Principal Investigators

• Gamze Bozkul · Tarsus University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-03

Primary Completion

2026-06-15

Completion

2027-09-15

Countries

• Turkey (Türkiye)

Study Locations