TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSYNCT07462390
Effect of Intrarectal Ice Application on Pain, Anxiety, Cortisol Levels, Development of Complications, and Hospital Readmission in Transrectal Ultrasound-Guided Prostate Biopsy
A study testing Intrarectal ıce in people with TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY
- What is being tested?
- Intrarectal ıce
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2026to 15 Sep 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients with a mental disorder
- Patients diagnosed with an anxiety disorder
- Patients using medication for anxiety control
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Intrarectal ıce
- Keywords
- pain, anxiety, cortisol levels, development of complications, hospital readmission
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrarectal ıceOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6 months
Cortisol level
Patient Follow-up Form: Patients' serum cortisol levels before and after the biopsy procedure will be recorded on this form.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start3 Mar 2026 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Sep 2027 (estimated)
Why it stopped: The clinical trial number for this study was previously assigned. This was done in error.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was planned as a randomized controlled experimental study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze BOZKUL, Tarsus University
- Investigators
- Gamze Bozkul, Principal investigator, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462390
- Sponsor's protocol ID
- TU-BOZKUL-017
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He J, Guo Z, Huang Y, Wang Z, Huang L, Li B, Bai Z, Wang S, Xiang S, Gu C, Pan J. Comparisons of efficacy and complications between transrectal and transperineal prostate biopsy with or without antibiotic prophylaxis. Urol Oncol. 2022 May;40(5):191.e9-191.e14. doi: 10.1016/j.urolonc.2022.01.004. Epub 2022 Feb 12.
PubMed 35168882Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.
PubMed 35397973Forsvall A, Jonsson H, Wagenius M, Bratt O, Linder A. Rate and characteristics of infection after transrectal prostate biopsy: a retrospective observational study. Scand J Urol. 2021 Aug;55(4):317-323. doi: 10.1080/21681805.2021.1933169. Epub 2021 Jun 7.
PubMed 34096449Chiu LP, Tung HH, Lin KC, Lai YW, Chiu YC, Chen SS, Chiu AW. Effectiveness of stress management in patients undergoing transrectal ultrasound-guided biopsy of the prostate. Patient Prefer Adherence. 2016 Feb 11;10:147-52. doi: 10.2147/PPA.S96991. eCollection 2016.
PubMed 26929606
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07462390
- Acronym / sponsor ID
- TU-BOZKUL-017
- Keywords
- pain, anxiety, cortisol levels, development of complications, hospital readmission
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The clinical trial number for this study was previously assigned. This was done in error.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 3 Mar 2026 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was planned as a randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Intrarectal ıceIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrarectal ıceIn 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 | Other | Experimental group |
Primary outcome
Pain Level
Time frame: 6 months
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.
Anxiety level
Time frame: 6 months
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
Cortisol level
Time frame: 6 months
Patient Follow-up Form: Patients' serum cortisol levels before and after the biopsy procedure will be recorded on this form.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Background: PubMed 35168882He J, Guo Z, Huang Y, Wang Z, Huang L, Li B, Bai Z, Wang S, Xiang S, Gu C, Pan J. Comparisons of efficacy and complications between transrectal and transperineal prostate biopsy with or without antibiotic prophylaxis. Urol Oncol. 2022 May;40(5):191.e9-191.e14. doi: 10.1016/j.urolonc.2022.01.004. Epub 2022 Feb 12.
- Background: PubMed 35397973Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.
- Background: PubMed 34096449Forsvall A, Jonsson H, Wagenius M, Bratt O, Linder A. Rate and characteristics of infection after transrectal prostate biopsy: a retrospective observational study. Scand J Urol. 2021 Aug;55(4):317-323. doi: 10.1080/21681805.2021.1933169. Epub 2021 Jun 7.
- Background: PubMed 26929606Chiu LP, Tung HH, Lin KC, Lai YW, Chiu YC, Chen SS, Chiu AW. Effectiveness of stress management in patients undergoing transrectal ultrasound-guided biopsy of the prostate. Patient Prefer Adherence. 2016 Feb 11;10:147-52. doi: 10.2147/PPA.S96991. eCollection 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamze Bozkul principal investigator
Tarsus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrarectal ıce in people with TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY, run by Tarsus University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07462390, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.