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

NCT06802783 | Active Not Recruiting

• 1 other identifier: MAR.UAD.0017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Biopsy

Keywords

prostate biopsy; anxiety; pain; depression

Outcome Measures

Primary 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.

  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.

  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.

  Pre procedure

Secondary Outcomes (3)

• Anxiety Level

  Immediately after the procedure

• Depression Level

  Immediately after the procedure

• Pain Level

  Immediately after the procedure

Study Arms (2)

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

Other: Photo consent

Interventions

Photo consent 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.

photo-consent group

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine Urology Department

Istanbul, Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• BAHADIR SAHIN

  MARMARA UNİVERSİTY SCHOOL OF MEDİCİNE DEPARTMENT OF UROLOGY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 31, 2025
• Study Start: January 1, 2024
• Primary Completion: November 12, 2024
• Study Completion: January 30, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)