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
| Registry | NCT07462390 |
|---|---|
| Status | Withdrawn - The clinical trial number for this study was previously assigned. This was done in error. |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, other |
| Sponsor | Tarsus University (Other) |
| Conditions | TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY |
| Interventions | Intrarectal ıce (Other) |
| Dates | start 2026-03-03 (estimated), primary completion 2026-06-15 (estimated), completion 2027-09-15 (estimated), first posted 2026-03-10, last updated 2026-03-24 |
| Locations | 1 site in Turkey (Türkiye) |
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All trials for TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY All trials of Intrarectal ıce
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 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Experimental group | Experimental | 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 readmit |
| 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 |
Sex: Male, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Tarsus University | Mersin, Turkey | Turkey (Türkiye) |