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Completed

NCT Number: NCT04466202

Effectiveness of the Music With Structured Verbal Training During Prostate Biopsy

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.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Behavior Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Personal Satisfaction Satisfaction Signs and Symptoms Urological Nursing

Age range

40 year–86 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Saglik Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music with Structured Verbal Training

Other

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.

Primary outcomes

  1. change on pain intensity as measured by Visual Analog Scale

    Time frame: "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 outcomes

  1. score change on anxiety level as measured by State-Trait Anxiety Inventory

    Time frame: "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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 10, 2020
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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