Prostate CancerNCT06998121
The Effect of Intrarectal Ice Application on Pain, Anxiety, Cortisol Level, Complication Development in Transrectal Ultrasonography Guided Prostate Biopsy
A study testing Intrarectal ıce application in people with Prostate Cancer, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Intrarectal ıce application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 15 Apr 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- Patients with mental disorders,
- Patients diagnosed with anxiety disorder,
- Patients taking medication for anxiety control.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intrarectal Ice Application on Pain, Anxiety, Cortisol Level, Complication Development and Re-admission to Hospital in Transrectal Ultrasonography Guided Prostate Biopsy
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.
Read more
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.
- Conditions
- Prostate Cancer
- Being tested
- Intrarectal ıce application
- Keywords
- Transrectal ultrasound (TRUS)-guided prostate biopsy, intrarectal ice application, pain, anxiety, cortisol levels
- Medical subject headings
- Prostatic Neoplasms, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrarectal ıce applicationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | 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 placed in the patient's rectum and held there for 5 minutes (Caliskan and Mutlu, 2015).
Pain and anxiety will be assessed in all patients during and after the procedure. At the end of the prostate biopsy, 2 ml of blood will be collected again from the patients to measure serum cortisol levels. The occurrence of complications will be determined by researchers (E.K.D. and G.B.) via telephone during the procedure and one week later. Additionally, when researchers call the patient one week later, they will inquire about any subsequent hospital visits during that period. All information will be recorded on the necessary forms. Receives: Other: Intrarectal ıce application |
| contrl | No intervention | At the outpatient clinic where the study was conducted, oral antibiotic treatment (2x1 Iesef 1 g) was started 24 hours before the prostate biopsy and continued until the dose was completed. A B.T. ENEMA is performed the night before the procedure and at 6:00 a.m. on the day of the procedure. During the procedure, biopsy samples are taken from 12 different areas using a fine needle guided by transrectal ultrasound. Patients who experience pain after the procedure are advised to take oral analgesics (paracetamol). Additionally, patients are informed about precautions to take after the procedure (e.g., seeking medical attention in cases of fever ≥38.5°C and excessive haematuria, avoiding spicy foods for two weeks, etc.). Furthermore, no measures are taken in the outpatient clinic to control pain or anxiety during prostate biopsy. Patients in the control group will receive the outpatient clinic's routine treatment and care. Translated with DeepL.com (free version) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
The State Anxiety Scale : In this study, the DAQ, which is structured to measure momentary feelings, was used. Its Turkish validity and reliability was conducted by Öner and Le Compte in 1983. The DAQ consists of 20 questions on a four-point Likert scale. The statements in the DAQ are evaluated as not at all (1), a little (2), a lot (3) and completely (4). In this section, the statements are divided into direct and reversed statements. Inverted statements: 1st, 2nd, 5th, 5th, 8th, 8th, 10th, 11th, 15th, 16th, 19th, 20th items. The total score of the reversed statements is subtracted from the total score of the direct statements and the number 50, which is the invariant value of the DAQ, is added to the value obtained and the DAQ score is calculated. The scale score ranges between 20-80 and an increase in the score indicates an increase in the level of anxiety.
Measured: 12 months
Pain score
Visual Analog Scale: It is a scale that provides a subjective assessment of pain on a horizontal or vertical line from 0 (no pain at all)-10 (very severe pain) to evaluate the level of pain (Wewers and Lowe, 1990).
Measured: 12 months
Patient Outcomes
Patient Follow-up Form: This form will record patients' serum cortisol levels before and after the biopsy procedure, complications that develop within one week after the biopsy (rectal bleeding, haematuria, urinary retention, anaemia, infection, etc.) and whether the patient returns to the hospital during this period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Dec 2025
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- As a randomised controlled clinical trial, the study population will consist of patients who visit the Urology Outpatient Clinic at Mersin University Hospital and who will undergo transrectal ultrasound-guided prostate biopsy.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Collaborators
- Tarsus University
- Responsible party
- Principal investigator, Elife Kettas Dolek, Mersin University
- Investigators
- GAMZE BOZKUL, Principal investigator, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998121
- Sponsor's protocol ID
- MU-001
- Status last verified
- Aug 2026
- First submitted
- 29 May 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intrarectal Ice Application on Pain, Anxiety, Cortisol Level, Complication Development and Re-admission to Hospital in Transrectal Ultrasonography Guided Prostate Biopsy
- ClinicalTrials.gov ID
- NCT06998121
- Acronym / sponsor ID
- MU-001
- Conditions
- Prostate Cancer
- Keywords
- Transrectal ultrasound (TRUS)-guided prostate biopsy, intrarectal ice application, pain, anxiety, cortisol levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Collaborators
- Tarsus University
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 31 May 2025 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- As a randomised controlled clinical trial, the study population will consist of patients who visit the Urology Outpatient Clinic at Mersin University Hospital and who will undergo transrectal ultrasound-guided prostate biopsy.
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: Intrarectal ıce applicationPatients 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 placed in the patient's rectum and held there for 5 minutes (Caliskan and Mutlu, 2015). Pain and anxiety will be assessed in all patients during and after the procedure. At the end of the prostate biopsy, 2 ml of blood will be collected again from the patients to measure serum cortisol levels. The occurrence of complications will be determined by researchers (E.K.D. and G.B.) via telephone during the procedure and one week later. Additionally, when researchers call the patient one week later, they will inquire about any subsequent hospital visits during that period. All information will be recorded on the necessary forms. |
| contrl | No intervention | –At the outpatient clinic where the study was conducted, oral antibiotic treatment (2x1 Iesef 1 g) was started 24 hours before the prostate biopsy and continued until the dose was completed. A B.T. ENEMA is performed the night before the procedure and at 6:00 a.m. on the day of the procedure. During the procedure, biopsy samples are taken from 12 different areas using a fine needle guided by transrectal ultrasound. Patients who experience pain after the procedure are advised to take oral analgesics (paracetamol). Additionally, patients are informed about precautions to take after the procedure (e.g., seeking medical attention in cases of fever ≥38.5°C and excessive haematuria, avoiding spicy foods for two weeks, etc.). Furthermore, no measures are taken in the outpatient clinic to control pain or anxiety during prostate biopsy. Patients in the control group will receive the outpatient clinic's routine treatment and care. Translated with DeepL.com (free version) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
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 ıce applicationPatients 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). | Other | experimental |
Primary outcome
Anxiety
Time frame: 12 months
The State Anxiety Scale : In this study, the DAQ, which is structured to measure momentary feelings, was used. Its Turkish validity and reliability was conducted by Öner and Le Compte in 1983. The DAQ consists of 20 questions on a four-point Likert scale. The statements in the DAQ are evaluated as not at all (1), a little (2), a lot (3) and completely (4). In this section, the statements are divided into direct and reversed statements. Inverted statements: 1st, 2nd, 5th, 5th, 8th, 8th, 10th, 11th, 15th, 16th, 19th, 20th items. The total score of the reversed statements is subtracted from the total score of the direct statements and the number 50, which is the invariant value of the DAQ, is added to the value obtained and the DAQ score is calculated. The scale score ranges between 20-80 and an increase in the score indicates an increase in the level of anxiety.
Pain score
Time frame: 12 months
Visual Analog Scale: It is a scale that provides a subjective assessment of pain on a horizontal or vertical line from 0 (no pain at all)-10 (very severe pain) to evaluate the level of pain (Wewers and Lowe, 1990).
Patient Outcomes
Time frame: 12 months
Patient Follow-up Form: This form will record patients' serum cortisol levels before and after the biopsy procedure, complications that develop within one week after the biopsy (rectal bleeding, haematuria, urinary retention, anaemia, infection, etc.) and whether the patient returns to the hospital during this period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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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 application in people with Prostate Cancer, run by Mersin 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: finished, as of the sponsor's last update on 12 Aug 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anxiety (time frame: 12 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?
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 12 Aug 2026.