Clinical trial NCT06998121: The Effect of Intrarectal Ice Application on Pain, Anxiety, Cortisol Level, Complication Development in Transrectal Ultrasonography Guided Prostate Biopsy
Official title: The Effect of Intrarectal Ice Application on Pain, Anxiety, Cortisol Level, Complication Development and Re-admission to Hospital in Transrectal Ultrasonography Guided Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Transrectal Ultrasound (TRUS)-Guided Prostate Biopsy
Keywords: Transrectal ultrasound (TRUS)-guided prostate biopsy
intrarectal ice application
pain, anxiety, cortisol levels
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 84
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: As a randomised controlled clinical trial, the study population will consist of patients who visit the Urology Outpatient Clinic at Mersin University Hospital and who will undergo transrectal ultrasound-guided prostate biopsy.
Primary purpose: OTHER

Brief 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.


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.

Primary outcomes:
measure: Anxiety
timeFrame: 12 months
measure: Pain score
timeFrame: 12 months
measure: Patient Outcomes
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: