Effectiveness of the Music With Structured Verbal Training During Prostate Biopsy

The Effect of Music With Structured Verbal Training on Pain, Anxiety and Satisfaction During Prostate Biopsy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04466202

Enrollment

100

Registered

2020-07-10

Start date

2020-01-22

Completion date

2020-12-31

Last updated

2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pain, Satisfaction, Urological Nursing

Keywords

Anxiety, Nursing, Pain, Satisfaction, Prostate biopsy

Brief summary

Transrectal ultrasound (TRUS) guided prostate biopsy is a gold standard method widely used in the diagnosis of prostate cancer. This procedure can be very painful and anxious for men. Various pharmacological methods can be used to relieve patients' pain and discomfort during TRUS-guided prostate biopsy. Although there is still no consensus on the solution suggestions for pain and anxiety due to biopsy, it is known that music, which is a non-pharmacological method, is effective in this regard. The aim of this study is to evaluate the effect of music with structured verbal training on patients' pain, anxiety and satisfaction levels during transrectal ultrasound-guided prostate biopsy.

Detailed description

Although there have been several studies examining the effect of music on pain and / or anxiety during TRUS prostate biopsy, only one study has been found examining the effect of stress management (music and one-to-one simulation training) on patients' pain and anxiety levels. In addition, there is only one study on the effectiveness of the training method (written and video-based training) on anxiety levels of patients related to prostate biopsy. For this reason, it is thought that music will be more effective on pain and anxiety levels along with structured verbal training to alleviate the discomfort associated with patients' biopsy procedure.

Interventions

OTHERMusic with Structured Verbal Training

Structured verbal training on prostate biopsy was given to the intervention group before the procedure, and then patients in this group listened to the music they preferred during the procedure with headphones.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to 86 Years

Healthy volunteers

Yes

Inclusion criteria

* being over the age of 40 * male gender * transrectal ultrasound guided prostate biopsy for the first time * agreeing to participate in the study

Exclusion criteria

* presence of any contraindication for prostate biopsy * any analgesic used 24 hours before prostate biopsy

Design outcomes

Primary

Measure	Time frame	Description
change on pain intensity as measured by Visual Analog Scale	just before procedure, during procedure and 5 minutes after procedure	The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm (0-100 mm). High scores on the scale indicate that pain intensity is high.

Secondary

Measure	Time frame	Description
score change on anxiety level as measured by State-Trait Anxiety Inventory	just before procedure and 5 minutes after procedure	The average score change on anxiety level as measured by State-Trait Anxiety Inventory. This scale is used to measure anxiety. The scores on the scale ranges from 20 to 80. The high scores on the scale indicate that anxiety is high.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026