Effectiveness of the Music With Structured Verbal Training During Prostate Biopsy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Anxiety, Satisfaction, Urological Nursing

Intervention / Treatment
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* Other: Music with Structured Verbal Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 86 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Group with Structured Verbal Training<br>Music with structured verbal training was applied during transrectal ultrasound guided prostate biopsy. | Other: Music with Structured Verbal Training<br>* 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.<br>|
| No Intervention: Control Group<br>The control group did not listen to music during the procedure, and they received routine training. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change on pain intensity as measured by Visual Analog Scale | 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. | just before procedure, during procedure and 5 minutes after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score change on anxiety level as measured by State-Trait Anxiety Inventory | 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. | just before procedure and 5 minutes after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Nursing, Pain, Satisfaction, Prostate biopsy