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

NCT06998121 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-03-24

No results posted yet for this study

Summary

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

Interventions

OTHER

Intrarectal ıce application

Patients included in the study group will receive intrarectal ice application by researchers (E.K.D. and M.B.) in addition to the outpatient clinic's routine treatment and care practices. For each patient, a new glove (size 8) will be filled with water and frozen to obtain the cold application material. Immediately before the procedure, the lubricated ice will be inserted into the patient's rectum and held in place for 5 minutes (Caliskan and Mutlu, 2015).

Sponsors & Collaborators

  • Tarsus University

    collaborator OTHER

  • Mersin University

    lead OTHER

Principal Investigators

  • GAMZE BOZKUL · Tarsus University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-03-19
Completion
2026-05-15

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06998121 on ClinicalTrials.gov