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The effect of listening to music on pain experienced during a prostate biopsy. A randomized controlled trial.

The effect of listening to music on pain experienced during a prostate biopsy. A randomized controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27997
Enrollment
60
Registered
2017-02-11
Start date
2016-12-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Pain, prostate biopsy Pijn, prostaatbiopsie

Interventions

Patients are randomly allocated to one of the two groups: 1. Intervention group: usual care with music intervention during prostate biopsy 2. Control group: usual care during prostate biopsy The m

Sponsors

Sponsor Ziekenhuis Gelderse Vallei postadres P.O. Box 9025 postcode 6710 HN stad Ede land The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

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) • Signed informed consent

Exclusion criteria

Exclusion criteria: • Prostate biopsy in combination with another physical examination, such as cystoscopy • Request for an anaesthetic during the prostate biopsy • Previously having had a prostate biopsy • Hearing impairment or blindness • Problems in the rectal area (haemorrhoids, anal fissure or clinically evident prostatitis)

Design outcomes

Primary

MeasureTime frame
Pain level before and maximum pain level during the prostate biopsy, as assessed with a Visual Analogue Scale (VAS) for pain.

Secondary

MeasureTime frame
1. Anxiety level before and maximum level during the prostate biopsy, as assessed with a Visual Analogue Scale (VAS) for anxiety. 2. Acceptability of the pain during the prostate biopsy, as assessed with a question and with the answer options ‘yes’ or ‘no’.

Contacts

Public ContactMachteld Molkenboer-Oortwijn

Polikliniek Urologie

molkenboerm@zgv.nl+31 (0)318 433 086

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)