The effect of Virtual Reality on pain in patients undergoing lumbar puncture. A randomized controlled trial

Recruiting

Conditions: Pijn en angst gerelateerd aan diagnostische ingreep (lumbaalpunctie)
Pain in lumbar punctures / spinal tap
10001316
10009720

Registration Number: NL-OMON51820

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 140

Inclusion Criteria

- At least 18 years
- Indication for lumbar puncture
- Outpatient setting

Exclusion Criteria

- Any contraindication for lumbar puncture:
o Suspicion of increased intracranial pressure in decreased consciousness,
papilledema, focal loss or suspected increased intracranial pressure based on
imaging
o Space occupying lesions with mass effect
o Space occupying lesions in posterior fossa of any kind such as tumor,
hemorrhage or recent cerebellar infarction
o Spinal mass
o Infection at puncture site
o Thrombocytopenia <40x10*
o Use of blood-thinning medication (with the exception of acetylsalicylic acid)
- Patients who have epilepsy
- Patients who have had lumbar puncture before
- Patients who are completely deaf or blind

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is experienced pain measured by the 11-point NRS. Scores<br /><br>will be analysed by means with standard deviations. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Anxiety: Anxiety will be measured with the 11-point NRS. This is a validated<br /><br>and reliable scale for measuring state anxiety. This will be measured before<br /><br>and after the procedure. In patients with VR the measurement of NRS will take<br /><br>place before starting the VR.<br /><br>Complications: Complications will be assessed in a telephone call 3-5 days<br /><br>after the puncture.<br /><br>Side-effect: Side effects of VR will be assessed after the procedure. </p><br>