The effect of listening to music on pain experienced during a prostate biopsy. A randomized controlled trial.
Recruiting
- Conditions
- Pain, prostate biopsyPijn, prostaatbiopsie
- Registration Number
- NL-OMON27997
- Lead Sponsor
- SponsorZiekenhuis Gelderse Valleipostadres P.O. Box 9025 postcode6710 HN stadEdelandThe Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
• Age ≥35 years
• Prostate biopsy to confirm or deny the presence of prostate cancer (in addition to elevated prostate-specific antigen and/or abnormal (digital) rectal examination findings)
Exclusion Criteria
• Prostate biopsy in combination with another physical examination, such as cystoscopy
• Request for an anaesthetic during the prostate biopsy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain level before and maximum pain level during the prostate biopsy, as assessed with a Visual Analogue Scale (VAS) for pain.
- Secondary Outcome Measures
Name Time Method 1. Anxiety level before and maximum level during the prostate biopsy, as assessed with a Visual Analogue Scale (VAS) for anxiety.<br /><br>2. Acceptability of the pain during the prostate biopsy, as assessed with a question and with the answer options ‘yes’ or ‘no’.<br>