search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number26692
- NTR NumberNTR6235
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-feb-2017
- Secondary IDsZiekenhuis Gelderse Vallei identifying number 1611-597
- Public TitleThe effect of listening to music on pain experienced during a prostate biopsy. A randomized controlled trial.
- Scientific TitleThe effect of listening to music on pain experienced during a prostate biopsy. A randomized controlled trial.
- ACRONYMNot applicable
- hypothesisListening to music by using an audio pillow, will reduce the pain experienced during an ultrasound-guided prostate biopsy,
- Healt Condition(s) or Problem(s) studiedPain, Prostate biopsy
- 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• 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)
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- control[default]
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2016
- planned closingdate1-okt-2017
- Target number of participants60
- InterventionsPatients 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).
- Primary outcomePain level before and maximum pain level during the prostate biopsy, as assessed with a Visual Analogue Scale (VAS) for pain.
- Secondary outcome1. 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’.
- TimepointsThere 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.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMw. Machteld Molkenboer-Oortwijn
- CONTACT for SCIENTIFIC QUERIESMw. Machteld Molkenboer-Oortwijn
- Sponsor/Initiator Ziekenhuis Gelderse Vallei
- Funding
(Source(s) of Monetary or Material Support)
Ziekenhuis Gelderse Vallei
- Publications
- Brief summaryBackground:
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)
- Main changes (audit trail)
- RECORD11-feb-2017 - 29-apr-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl