RecruitingNot ApplicableNCT06998121

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


Sponsor

Mersin University

Enrollment

84 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria8

  • 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 Criteria9

  • 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.

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Interventions

OTHERIntrarectal 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).


Locations(2)

Mersin Unıversıty

Mersin, Turkey (Türkiye)

Mersin Unıversıty

Mersin, Turkey (Türkiye)

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NCT06998121


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