To evaluate the effect of an immersive VR environment on procedural anxiety in patients undergoing TAVI under local anaesthesia in a randomized controlled setting.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: Procedural anxiety assessed on a visual analogue scale (VAS)
directly post-procedure.
Secondary outcome
Patient procedural satisfaction
Change in anxiety pre- vs. postprocedure
Procedural pain assessed on a VAS directly post-procedure
Procedural sedative use and dosage
Procedural analgesic use and dosage
Procedural nausea
Procedural vomiting
Admission time
Background summary
In the last decade, transcatheter aortic valve implantation (TAVI) has matured
into a minimally invasive procedure under local anaesthesia. Although local
anaesthesia may reduce complication rates (particularly delirium and hospital
acquired infections), patients might experience procedural discomfort. Pain and
anxiety may lead to administration of additional sedation or conversion to
general anaesthesia. Although not extensively researched in TAVI, procedural
anxiety is associated with worse outcome in cardiovascular procedures under
local anaesthesia. Pharmacological treatment can reduce anxiety, but may
introduce additional hazards and prolong in-hospital and intensive care unit
stay.
Virtual reality (VR) allows patients to be fully immerged in an engaging,
interactive 3-D environment. Its applications are broad and include treatment
of phobias, stress-disorders, pain reduction. Recently, VR has been adopted in
various medical procedures to reduce pre- and per-procedural anxiety. In TAVI,
per-procedural VR immersion could potentially reduce patient anxiety leading to
increased overall patient satisfaction. However, contemporary large scale,
randomized evidence on VR application in TAVI is lacking
Study objective
To evaluate the effect of an immersive VR environment on procedural anxiety in
patients undergoing TAVI under local anaesthesia in a randomized controlled
setting.
Study design
International multi-center randomized controlled trial
Intervention
VR-immersion using a head mounted VR-device during TAVI procedure
Study burden and risks
The current application of VR is as a non-invasive modality associated with no
significant risks. Previous studies have reported nausea, vomiting and
headaches as a result of VR-use (i.e. cybersickness). However, these rates are
low in elderly patients and are easily treated (by removing the device). In
this study, we will not use concomitant headphones or earplugs as direct
contact and the option to instruct the patient need to be preserved during the
procedure. Additionally, to limit excessive movement by the patient, the
VR-immersion does not involve a user-held controller. The level of interaction
thereby is limited to subtle head movements which will not influence the TAVI
procedure, which is executed according to standard of care. Use of this VR
application will not affect the standard procedure flow of a TAVI procedure.
Potential benefits of VR-immersion in TAVI are reduction in procedural anxiety,
reduction in subjective pain and possible reduction in analgesics. It may
enhance the overall patient experience and increase patient satisfaction
scores.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
o Age * 18 years
o Symptomatic severe aortic stenosis
o Indication for transfemoral TAVI under local anaesthesia per local heart team
consensus
o Patient is able to understand and sign written informed consent
o Patient speaks Dutch, German or English
Exclusion criteria
o Need for emergent TAVI
o Need for planned concomitant cardiac intervention during index procedure
o History of TAVI under local anesthesia/conscious sedation
o Chronic use of benzodiapines, opioids, pregabalin or antidepressants
o History of opioid use (within 8-30 days prior to randomization)
o Claustrophobia
o Any psychiatric illness diagnosed by a psychiatrist or psychologist
o Blindness or severe visual impairment despite visual aid (glasses, contact
lenses)
o Epilepsy
o Extensive cognitive impairment (MMSE <21 or as diagnosed by geriatrician)
Design
Recruitment
Medical products/devices used
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 | NL77298.078.21 |