The aim of this study is to determine whether VR used during lumbar puncture will significantly reduce pain and anxiety perception.
ID
Source
Brief title
Condition
- Other condition
- Administration site reactions
- Nervous system, skull and spine therapeutic procedures
Synonym
Health condition
Pijn en angst gerelateerd aan diagnostische ingreep (lumbaalpunctie)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is experienced pain measured by the 11-point NRS. Scores
will be analysed by means with standard deviations.
Secondary outcome
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.
Background summary
Lumbar puncture (LP) is considered safe with a low risk of complications.
However, LP are often experienced as painful, unpleasant and distressing, which
is associated with more pain and anxiety. There is increasing evidence that
virtual reality is effective in the reduction of acute pain during medical
procedures and treatments. [9] Furthermore it has been proven to reduce
pre-operative anxiety, mainly in children. [15] There is a tendency of pain
reduction with the use of VR in adolescents undergoing LP [8]. VR has not been
studied in adults undergoing LP.
Study objective
The aim of this study is to determine whether VR used during lumbar puncture
will significantly reduce pain and anxiety perception.
Study design
A single center, non-blinded, randomized controlled trail.
Intervention
Patients in the intervention group will have additional VR-experience before
and during LP.
Study burden and risks
Patients included in this study will have a negligible medical risk when
participating in this study, since VR has minimal and non-threatening
side-effects (e.g. dizziness). The burden to participate in the study is also
low considering that only an extra telephone call, which will take maximum of
15 minutes, is done on top of normal LP procedure.
Henri Dunantstraat 5
Heerlen 6419PC
NL
Henri Dunantstraat 5
Heerlen 6419PC
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79216.096.21 |