Since Triggerfinger and Carpal tunnel syndrome are hand disorders most commonly presented at the outpatient clinic, the aim of our study is to investigate what the effect is of virtual reality use during wide awake local anesthetic tourniquet &…
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Multiple outcomes were measured, of which all were measured both
peri-operatively, direct post-operatively as well as 2 weeks post-operatively.
We divided the outcome measures in three groups: Patient reported outcomes
(PROMS), Patient reported experience outcomes (PREMS) and objective outcomes.
Below we will elaborate on these different sets of outcomes.
PROMS
We measured pain, fun, nausea and relaxation using a 0-10 Likert Scale during
peri-operatively and direct post-operatively. In addition, we asked patients to
fill in the PHQ-4 questionaire for anxiety peri-operatively and direct
post-operatively.
Furthermore, patients were asked to fill in the Michigan hand
questionnaire/DASH at 2 weeks post-operatively.
PREMS
CQ-index was asked to be filled in after two weeks post-operatively to assess
what the overall experience was the given treatment
Secondary outcome
Heartrate, blood pressure right before, during and direct post-operatively
Background summary
Patients undergoing wide awake local anesthetic surgery often experience pain
and anxiety during the procedure. Due to the pain and anxiety, patients are
often stressed and hesitant in undergoing wide awake surgery. The use of
virtual reality (VR) has potential in various aspects in medicine as multiple
studies showed promising results in terms of pain and anxiety.1 Furthermore, a
systematic review studying the use of VR as a psychological intervention for
pain management showed that VR based interventions lead to a pain reduction in
patients undergoing medical procedures.2 Moreover, a systematic review by Zeng
et al. studying the use of VR in symptom reduction in cancer patients showed
significant positive results in regard to depression, cognitive function, pain
and anxiety.3
Despite the growing evidence that VR has positive effects in patients, there
are to date no publications demonstrating the use of virtual reality in hand
surgery. As a result, it is unknown what the effect of VR-interventions is in
patients undergoing wide awake local hand surgery with or without tourniquet.
VR interventions during wide awake hand surgery might have the potential of
reducing pain, anxiety and as a result better patient experience. In addition,
the often applied tourniquet in local hand surgery is usually regarded as very
unpleasant, sometimes even the most uncomfortable part of the procedure.
Study objective
Since Triggerfinger and Carpal tunnel syndrome are hand disorders most commonly
presented at the outpatient clinic, the aim of our study is to investigate what
the effect is of virtual reality use during wide awake local anesthetic
tourniquet & non-tourniquet surgery on both patient reported experience outcome
(PREMS), patient reported treatment outcomes (PROMS) as well as objective
outcomes in patients treated for their Trigger Finger or Carpal tunnel
syndrome.
Study design
The study will be conducted as a randomized controlled trial following the
CONSORT guideline and performed at the outpatient clinic for plastic,
reconstructive and hand surgery in Isala hospital, located in Zwolle, the
Netherlands
Intervention
After written informed consent, patients were randomly allocated in either the
group that received VR experience (VR group) or in the group that does not
receive VR experience (control group). After allocation, the VR group received
a VR goggle with headphones. During the procedure, each patient had the option
to select their own preferable VR movie clip. The options ranged from scenery
in wild forests to historical cities. The control group received routine
standard care.
Study burden and risks
Not applicable
Gebouw P Plastische chirurgie, Dr. Van Heesweg 2
Zwolle 8025AB
NL
Gebouw P Plastische chirurgie, Dr. Van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
Inclusion criteria
All patients who visited the outpatient clinic and were diagnosed with either
carpal tunnel syndrome or triggerfiger of a single digit and suitable for
undergoing wide awake local anesthetic surgery were asked to participate in
this study.
Exclusion criteria
Exclusion criteria was motion sickness, unwillingness to wear bands around the
head, patients younger than 18 years old or patients with claustrofobia.
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 | NL72717.075.20 |
| Other | NL8515 |