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

NCT07462390 | Withdrawn

• 1 other identifier: TU-BOZKUL-017
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pain; anxiety; cortisol levels; development of complications; hospital readmission

Outcome Measures

Primary Outcomes (3)

• Pain Level

  This scale allows patients to evaluate their level of pain on a line ranging from 0 (no pain) to 10 (extremely severe pain). It will be used to assess the intensity of pain experienced by the patients.

  6 months

• Anxiety level

  State Anxiety Scale: The scale developed by Spielberger et al. in 1970 consists of two components: the State Anxiety Scale (SAS), which determines how an individual feels at a particular moment and under specific conditions, and the Trait Anxiety Scale, which determines how an individual generally feels regardless of the current situation or conditions. In this study, the State Anxiety Scale (SAS), which is structured to measure momentary feelings, will be used. The Turkish validity and reliability study of the scale was conducted by Öner and Le Compte in 1983. The SAS consists of 20 items in a four-point Likert-type format. The items are rated as: not at all (1), somewhat (2), moderately (3), and completely (4). The total score ranges between 20 and 80, and higher scores indicate higher levels of anxiety. The reverse-scored items are items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The SAS score is calculated by subtracting the total score of the reverse-scored items from the total

  6 months

• Cortisol level

  Patient Follow-up Form: Patients' serum cortisol levels before and after the biopsy procedure will be recorded on this form.

  6 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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 readmit

Other: Intrarectal ıce

Control group

NO INTERVENTION

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 rec

Interventions

Intrarectal ıce OTHER

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only individuals who self-identify as male are eligible to participate in this study, as prostate biopsy is a procedure specific to the male population.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who agreed to participate in the study
• Patients aged 18 years and older
• Patients who were conscious, oriented, and cooperative
• Patients without communication problems
• Patients scheduled to undergo transrectal ultrasound-guided prostate biopsy for the first time
• Patients without a mental disorder
• Patients without a diagnosis of an anxiety disorder
• Patients not using medication for anxiety control

You may not qualify if:

• Patients who did not agree to participate in the study
• Patients under 18 years of age
• Patients who were not conscious, oriented, and cooperative
• Patients with communication problems
• Patients who did not undergo transrectal ultrasound-guided prostate biopsy
• Patients who had previously undergone prostate biopsy
• Patients with a mental disorder
• Patients diagnosed with an anxiety disorder
• Patients using medication for anxiety control

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus University

Mersin, Turkey, 33400, Turkey (Türkiye)

Location

Related Publications (4)

• , J., Guo, Z., Huang, Y., Wang, Z., Huang, L., Li, B., Bai, Z., Wang, S., Xiang, S., Gu, C., & Pan, J. (2022). Comparisons of efficacy and complications between transrectal and transperineal prostate biopsy with or without antibiotic prophylaxis. Urologic Oncology, 40(5), 191.e9-191.e14. https://doi.org/10.1016/j.urolonc.2022.01.004

  BACKGROUND

• Genç, H., Korkmaz, M., & Akkurt, A. (2022). The effect of virtual reality glasses and stress balls on pain and vital findings during transrectal prostate biopsy: A randomized controlled trial. Journal of Perianesthesia Nursing, 37(3), 344-350. https://doi.org/10.1016/j.jopan.2021.09.006

  BACKGROUND

• Forsvall, A., Jönsson, H., Wagenius, M., Bratt, O., & Linder, A. (2021). Rate and characteristics of infection after transrectal prostate biopsy: a retrospective observational study. Scandinavian Journal of Urology, 55(4), 317-323. https://doi.org/10.1080/21681805.2021.1933169

  BACKGROUND

• Chiu, L. P., Tung, H. H., Lin, K. C., Lai, Y. W., Chiu, Y. C., Chen, S. S., & Chiu, A. W. (2016). Effectiveness of stress management in patients undergoing transrectal ultrasound-guided biopsy of the prostate. Patient Preference and Adherence, 10, 147-152. https://doi.org/10.2147/PPA.S96991

  BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Gamze Bozkul

  Tarsus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: When a decision is made to perform a prostate biopsy in the urology outpatient clinic, the researcher (M.B.) will evaluate patients for eligibility according to the study inclusion criteria. Patients will be assigned to groups using the block randomization method. According to the permutations (e.g., ABBA, BABA, etc.) generated in a computer-based randomization list prepared by a biostatistician who is not involved in the study, patients will be allocated to either the intervention or control group. After the randomization list is created, whether Group A or Group B represents the intervention or control group will be determined by drawing lots. The coordinator researcher (G.A.U.), who will not be involved in the data collection process, will prepare sealed envelopes numbered from 1 to 96 according to the sample size, and each envelope will contain a card indicating either group A or B. When the researcher (E.K.D.) meets the patient, they will open the numbered envelope obtained from
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study was planned as a randomized controlled experimental study

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: March 3, 2026
• Primary Completion: June 15, 2026
• Study Completion (Estimated): September 15, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)