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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY
• Intervention / Treatment: Other: Intrarectal ıce

Detailed Description

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.The data obtained from the study will be analyzed using computer-based statistical software. One month has been allocated for data analysis. Descriptive data will be expressed as percentages, means, and standard deviations. Categorical variables containing descriptive characteristics (such as educational status, marital status, presence of chronic disease, etc.) will be analyzed using the Chi-square test. The normality of the variables will be assessed using the Shapiro-Wilk test. In data analysis, when parametric test assumptions are met, independent and dependent samples t-tests will be used. If the data are nonparametric, the Mann-Whitney U test will be applied. For repeated measurements, if parametric assumptions are satisfied, one-way repeated measures analysis of variance (Repeated Measures ANOVA) will be used; if not, the Friedman test will be applied. For further analysis, appropriate post-hoc tests will be conducted for multiple within-group comparisons. A p-value of < .05 will be considered statistically significant.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Turkey
    • Mersin, Turkey, Turkey (Türkiye), 33400
      • Tarsus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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; 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
No Intervention: Control group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tarsus University
• Investigators: Principal Investigator: Gamze Bozkul, Tarsus University

Publications and helpful links

General Publications

• , 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
• 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
• 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
• 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

Study record dates

Study Major Dates

• Study Start (Estimated): March 3, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): September 15, 2027

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: pain; anxiety; hospital readmission; cortisol levels; development of complications
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders
• Other Study ID Numbers: TU-BOZKUL-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No