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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51820
Enrollment
140
Registered
2022-01-13
Start date
2023-02-04
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

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

Interventions

Patients in the intervention group will have additional VR-experience before and during LP.

Sponsors

Zuyderland Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - At least 18 years - Indication for lumbar puncture - Outpatient setting

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The primary outcome is experienced pain measured by the 11-point NRS. Scores will be analysed by means with standard deviations.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)