Prostate BiopsyNCT06802783
Impact of Procedure Materials on Patient Anxiety, Depression, and Pain in Prostate Biopsy Consent
A study testing Photo consent in people with Prostate Biopsy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The gold standard for diagnosing prostate cancer is an ultrasound-guided prostate biopsy. Despite its low complication rates, the procedure can cause significant stress, discomfort and anxiety in patients. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Biopsy
- What is being tested?
- Photo consent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patient's clinical data indicated the need for a prostate biopsy
Who cannot join
- included having a diagnosis of psychiatric illness
- having previously undergone a prostate biopsy under local anesthesia
- being a patient under active surveillance for prostate cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine Urology Department
Istanbul, Istanbul, 34854
About this study
The gold standard for diagnosing prostate cancer is an ultrasound-guided prostate biopsy. Despite its low complication rates, the procedure can cause significant stress, discomfort and anxiety in patients. This study aimed to determine whether visually introducing the materials (ultrasound, probe, biopsy needle) used during the biopsy could reduce patient anxiety and increase comfort.
Read the detailed description
Forty patients suspected of having prostate cancer were included in this prospective study. All patients received detailed information about the procedure, but they were divided into two groups. The first group was shown photographs of the devices alongside the written consent form, while the second group received only the written consent. The study compared the pain, depression and anxiety scores between the two groups
- Conditions
- Prostate Biopsy
- Being tested
- Photo consent
- Keywords
- prostate biopsy, anxiety, pain, depression
- Medical subject headings
- Anxiety Disorders, Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photo consentOther
The first group was shown photographs of the devices alongside the written consent form, while the second group received only the written consent. The study compared the pain, depression and anxiety scores between the two groups.
| Study group | Role | What they receive |
|---|---|---|
| written consent group | No intervention | Only traditional written consent will be provided to this group. |
| photo-consent group | Active comparator | Photo consent which show materials use in procedure will be provided to this group before the biopsy Receives: Other: Photo consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Level
For Anxiety, Hospital Anxiety Scale used. In the Hospital Anxiety Score, the minimum score is 0, and the maximum score is 21. As the score increases, it indicates higher levels of anxiety.
Measured: Pre-procedure
Depression Level
For Depression, Hospital Depression Scale used . In the Hospital Depression Score, the minimum score is 0, and the maximum score is 21. As the score increases, it indicates higher levels of depression.
Measured: Pre-procedure
Pain Level
For Pain, Visual Analog Scale used. In the Visual Analog Pain Scale, the minimum score is 0, and the maximum score is 10. As the score increases, it indicates higher levels of pain.
Measured: Pre procedure
Secondary outcomes (3)
Anxiety Level
For Anxiety, Hospital Anxiety Scale used. In the Hospital Anxiety Score, the minimum score is 0, and the maximum score is 21. As the score increases, it indicates higher levels of anxiety.
Measured: Immediately after the procedure
Depression Level
For Depression, Hospital Depression Scale used . In the Hospital Depression Score, the minimum score is 0, and the maximum score is 21. As the score increases, it indicates higher levels of depression
Measured: Immediately after the procedure
Pain Level
For Pain, Visual Analog Scale used. In the Visual Analog Pain Scale, the minimum score is 0, and the maximum score is 10. As the score increases, it indicates higher levels of pain.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Jan 2024
- Primary completion12 Nov 2024
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate BiopsyStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BAHADIR SAHIN, Study director, MARMARA UNİVERSİTY SCHOOL OF MEDİCİNE DEPARTMENT OF UROLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802783
- Sponsor's protocol ID
- MAR.UAD.0017
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Procedure Materials on Patient Anxiety, Depression, and Pain in Prostate Biopsy Consent
- ClinicalTrials.gov ID
- NCT06802783
- Acronym / sponsor ID
- MAR.UAD.0017
- Conditions
- Prostate Biopsy
- Keywords
- prostate biopsy, anxiety, pain, depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 31 Jan 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.
The gold standard for diagnosing prostate cancer is an ultrasound-guided prostate biopsy. Despite its low complication rates, the procedure can cause significant stress, discomfort and anxiety in patients. This study aimed to determine whether visually introducing the materials (ultrasound, probe, biopsy needle) used during the biopsy could reduce patient anxiety and increase comfort.
Detailed description
Forty patients suspected of having prostate cancer were included in this prospective study. All patients received detailed information about the procedure, but they were divided into two groups. The first group was shown photographs of the devices alongside the written consent form, while the second group received only the written consent. The study compared the pain, depression and anxiety scores between the two groups
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| written consent group | No intervention | –Only traditional written consent will be provided to this group. |
| photo-consent group | Active comparator | Other: Photo consentPhoto consent which show materials use in procedure will be provided to this group before the biopsy |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patient's clinical data indicated the need for a prostate biopsy
Key exclusion criteria (3 listed)
- included having a diagnosis of psychiatric illness
- having previously undergone a prostate biopsy under local anesthesia
- being a patient under active surveillance for prostate cancer
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 |
|---|---|---|
| Photo consentThe first group was shown photographs of the devices alongside the written consent form, while the second group received only the written consent. The study compared the pain, depression and anxiety scores between the two groups. | Other | photo-consent group |
Primary outcome
Anxiety Level
Time frame: Pre-procedure
For Anxiety, Hospital Anxiety Scale used. In the Hospital Anxiety Score, the minimum score is 0, and the maximum score is 21. As the score increases, it indicates higher levels of anxiety.
Depression Level
Time frame: Pre-procedure
For Depression, Hospital Depression Scale used . In the Hospital Depression Score, the minimum score is 0, and the maximum score is 21. As the score increases, it indicates higher levels of depression.
Pain Level
Time frame: Pre procedure
For Pain, Visual Analog Scale used. In the Visual Analog Pain Scale, the minimum score is 0, and the maximum score is 10. As the score increases, it indicates higher levels of pain.
3 secondary outcomes
Anxiety Level
Time frame: Immediately after the procedure
Depression Level
Time frame: Immediately after the procedure
Pain Level
Time frame: Immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- 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.
BAHADIR SAHIN study director
MARMARA UNİVERSİTY SCHOOL OF MEDİCİNE DEPARTMENT OF UROLOGY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photo consent in people with Prostate Biopsy, run by Marmara 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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 31 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 Level (time frame: Pre-procedure). 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 31 Jan 2025.