Effectiveness of the Music With Structured Verbal Training During Prostate Biopsy

Not Applicable

Completed

• Conditions: Pain; Urological Nursing; Satisfaction; Anxiety
• Interventions: Other: Music with Structured Verbal Training

• Registration Number: NCT04466202
• Lead Sponsor: Saglik Bilimleri Universitesi

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.

Study Timeline

• Study Start: 2020-01-22
• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-10
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music Group with Structured Verbal Training	Music with Structured Verbal Training	Music with structured verbal training was applied during transrectal ultrasound guided prostate biopsy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Saglik Bilimleri Universitesi; 🇹🇷 Istanbul, Turkey