Impact of Procedure Materials on Patient Anxiety, Depression, and Pain in Prostate Biopsy Consent

NCT ID: NCT06802783

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-01-30

Brief Summary

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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

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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

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Prostate Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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written consent group

Only traditional written consent will be provided to this group.

Group Type NO_INTERVENTION

No interventions assigned to this group

photo-consent group

Photo consent which show materials use in procedure will be provided to this group before the biopsy

Group Type ACTIVE_COMPARATOR

Photo consent

Intervention Type OTHER

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.

Interventions

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Photo consent

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- patient's clinical data indicated the need for a prostate biopsy

Exclusion Criteria

* 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
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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BAHADIR SAHIN

Role: STUDY_DIRECTOR

MARMARA UNİVERSİTY SCHOOL OF MEDİCİNE DEPARTMENT OF UROLOGY

Locations

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Marmara University School of Medicine Urology Department

Istanbul, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MAR.UAD.0017

Identifier Type: -

Identifier Source: org_study_id

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