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

M

Marmara University

Status

Active, not recruiting

Conditions

Prostate Biopsy

Treatments

Other: Photo consent

Study type

Interventional

Funder types

Other

Identifiers

NCT06802783
MAR.UAD.0017

Details and patient eligibility

About

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.

Full 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

Enrollment

40 patients

Sex

Male

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

written consent group
No Intervention group
Description:
Only traditional written consent will be provided to this group.
photo-consent group
Active Comparator group
Description:
Photo consent which show materials use in procedure will be provided to this group before the biopsy
Treatment:
Other: Photo consent

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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