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

NCT ID: NCT06998121

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-06-01

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.

Conditions

Transrectal Ultrasound (TRUS)-Guided Prostate Biopsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

experimental

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 placed in the patient's rectum and held there for 5 minutes (Caliskan and Mutlu, 2015).

Pain and anxiety will be assessed in all patients during and after the procedure. At the end of the prostate biopsy, 2 ml of blood will be collected again from the patients to measure serum cortisol levels. The occurrence of complications will be determined by researchers (E.K.D. and G.B.) via telephone during the procedure and one week later. Additionally, when researchers call the patient one week later, they will inquire about any subsequent hospital visits during that period. All information will be recorded on the necessary forms.

Group Type: EXPERIMENTAL

Intrarectal ıce application

Intervention Type: OTHER

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).

contrl

At the outpatient clinic where the study was conducted, oral antibiotic treatment (2x1 Iesef 1 g) was started 24 hours before the prostate biopsy and continued until the dose was completed. A B.T. ENEMA is performed the night before the procedure and at 6:00 a.m. on the day of the procedure. During the procedure, biopsy samples are taken from 12 different areas using a fine needle guided by transrectal ultrasound. Patients who experience pain after the procedure are advised to take oral analgesics (paracetamol). Additionally, patients are informed about precautions to take after the procedure (e.g., seeking medical attention in cases of fever ≥38.5°C and excessive haematuria, avoiding spicy foods for two weeks, etc.). Furthermore, no measures are taken in the outpatient clinic to control pain or anxiety during prostate biopsy. Patients in the control group will receive the outpatient clinic's routine treatment and care.

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Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Elife Kettas Dolek

DR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MU-001

Identifier Type: -

Identifier Source: org_study_id