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

Background:

In hospitals examinations and treatments are performed in which the patient experiences acute pain. Pain can be reduced by using pharmacological or non-pharmacological interventions or a combination of both. Listening to music is a non-pharmacological, non-invasive, inexpensive, safe and effective method to reduce pain and anxiety in painful interventions. It is widely used in the treatment of acute pain and has demonstrated a reduction in pain experience in various medical procedures. Men who undergo prostate biopsy often experience pain and fear.



Objective:

To determine if patients who undergo an ultrasound-guided prostate biopsy experience less pain when listening to relaxing and stress-reducing music during the prostate biopsy.



Study design:

Randomized controlled trial.



Primary outcome:

Level of pain before and maximum level during the prostate biopsy as assessed with a Visual Analogue Scale for pain (a straight horizontal line of fixed length, usually 100 mm, with the left end representing ‘no pain’ and the right end representing ‘the worst pain imaginable’).

Secondary outcome:

Level of anxiety before and during the prostate biopsy as assessed with a Visual Analogue Scale for anxiety (a straight horizontal line of fixed length, usually 100 mm, with the left end representing no anxiety and the right end representing ‘the most anxiety imaginable’).
Acceptability of the pain. This question can be answered with "yes" or "no."

Study population:

60 men suspected of having prostate cancer and scheduled for transrectal ultrasound-guided prostate biopsy between December 2016 and May 2017 in Hospital Gelderse Vallei Ede.



Inclusiecriteria:

• 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

Exclusiecriteria:

• 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)

Listening to music by using an audio pillow, will reduce the pain experienced during an ultrasound-guided prostate biopsy,

There will be two assessment times:

1. Before the prostate biopsy: VAS for pain and VAS for anxiety

2. Immediately after the prostate biopsy: VAS for pain and VAS for anxiety (to retrospectively assess the maximum level during the prostate biopsy), and acceptability of pain.

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 music intervention consists of relaxing and stress-reducing music, using an audio pillow. The music is standardly put on a volume of 50 dB and can be adapted to a for the participant pleasant volume (up to 60 dB).