Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03665233 |
| Other study ID # |
VRAB001 |
| Secondary ID |
2018-001559-10 |
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2020 |
| Est. completion date |
November 30, 2020 |
Study information
| Verified date |
July 2021 |
| Source |
Clinique Saint-Jean, Bruxelles |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Virtual reality has been used for acute pain management (burn patients) with positive
results. Hypnosis has known beneficial effects on patients in the peri-operative setting. The
investigators are combining both by giving a virtual reality hypnosis (VRH) session to the
patients during a known painful post-operative moment. (physiotherapy) It is the investigator
intention to compare pain after physiotherapy during the first 3 days after a total knee
arthroplasty, between 2 groups. One group , the VR group gets standard treatment with VRH and
the second, the sham group, gets standard treatment with a sham VR session.
Description:
Introduction: Postoperative pain frequently occurs after total knee arthroplasty. The IASP
defines pain as "an unpleasant sensory and emotional experience associated with actual or
potential tissue damage, or described in terms of such damage". Pain is a major cause of
post-operative distress and has a variety of side effects and complications. Chronic post
surgical pain is probably the most feared complication of acute pain. Therefore, adequate
pain control after surgery is mandatory.
In modern western healthcare, multi-modal pain treatment is the standard of care. This means
that a variety of drugs, acting on different receptors, are used alongside
non-pharmacological interventions, to decrease pain. Such an approach enables the physician
to use a lower concentration of a specific drug, in order to avoid adverse effects that can
occur when giving higher doses of one individual drug. These drugs are based on the analgesic
ladder of the WHO to relief cancer pain. From the different drugs that are used, the major
concern will be with the opioids, as they are known to have major complications. Especially
today in the USA there is an epidemic of opioid related deaths. Very often these drugs have
been prescribed in a post-operative setting. The search for a different non-pharmacological
analgesic treatment is today, more than ever, a pressing need.
Virtual reality (VR) is a non-pharmacological way to decrease pain in a number of different
situations. It has been around for some years, some articles describing VR in medicine are 25
years old but it only recently became a popular medical treatment since the introduction of
the Oculus Rift in 2014. Before that HMDs (head-mounted display) were expensive and very
bulky devices. Since the introduction of the Oculus Rift HMD the availability and usability
of VR has increased dramatically.
In the post-operative period pain at rest is generally reported to be acceptable by our
patients (VAS<3), but if movements are involved the pain increases to unacceptable levels.
Postoperative physiotherapy generally involves the use of a continuous passive motion (CPM),
a machine used for passive bending of the knee. This postoperative mobilization is one of the
major causes of pain in the aftermath of a total knee arthroplasty.
Available evidence: Virtual Reality (VR) has been shown to reduce pain in different
situations. From experimental pain in healthy subjects to changing dressing of burn patients,
several studies have shown the use of immersive VR therapy as an adjunct for pain treatment.
The use of VR in children has frequently been studied, as it decreases pain and anxiety
during painful medical procedures.
The combination of VR and standard treatment (ST) has shown to have a superior analgesic
efficacy compared to VR or ST alone .
In the medical VR world there are different types of applications. Some of these act as
"distractors" (playing games, looking at natural scenery) and some have included elements of
therapeutic hypnosis. With these applications the patients are (self)-induced in a hypnotic
state.
Medical hypnosis has been shown to have a tremendous impact on post-operative recovery,
reducing anxiety and pain. Medical hypnosis is a one on one intervention, making it time and
labor consuming and people using hypnosis need to be well trained to perform the technique
safely. Bringing a patient in a hypnotic state can only be achieved by using appropriate
verbal quotes and this can be problematic if the patient speaks another language.
Although the surgical population would benefit greatly by using medical hypnosis, only few
patients are offered this technique.
Using a VR application with therapeutic hypnotic elements can be a great way to share with
many patients the positive effects of hypnotic therapy.
Trial : the investigators decided therefore to use a medical VR application that includes
therapeutic hypnotic elements. They want to compare the analgesic efficacy of standard
treatment with medical virtual reality and standard treatment with a sham VR session in
postoperative pain management, after the patient have had a session of physiotherapy, as this
is a painful moment in the post operative period. Using a sham VR session is lickely to
produce some sort of analgesia as any disctraction with VR can have a positive effect. But
this sham session isn't an enjoyable VRH session, therefore the authors still expect a
significant difference in pain reduction.
Using the sham seems inevitbale because it is not possible to blind the patients otherwise to
their own traetment. If the authors would use use a control group there would be a high risk
of biais because of the dissapointement for the patients not receiving any VR.
Each includable patient will be approached before the day of surgery and asked for
participation in the study, after verifying the absence of any exclusion criteria.
The investigators will present the study to the patients, using a patient oriented
explicatory form, after which they will look at the informed consent together with the
patient. If necessary they will give the patient some time to reflect and come back after a
while, to sign and collect, or not, the informed consent.
Randomization will be done earlier using a web based block randomization program :
www.randomization.com Each patient will be assigned to either a standard treatment with VR
sham group (Sh-group) or a standard treatment with Virtual reality group (VR-group). The
virtual reality will be an application designed by Oncomfort®. It is a session called AQUA,
which includes an underwater experience guided by a whale. The VR sham experience is also an
underwater based experience but without any coherence between the different images. The HMD
is a VR Gear from Samsung-Oculus and the mobile phone used is a Samsung Galaxy 7.
Interventions happen on the day of surgery (DOS), on post operative day 1-2 and 3 (POD1, POD2
and POD3. )
On the day of surgery :
Before going to the OR each included patient (both VR and Sh group) fills in a STAI Y
questionnaire gives a VAS pain score Before going to the OR, patients in the VR group get
additionally a 45 min session of VR : AQUA and patients in the Sh group get 45 min of a sham
session.
Each patient gets a TKA. There is no interference with the anaesthesia protocol. This is, as
usual, decided between the patient and the anaesthetist working in the OR. Some parts of the
peri-operative and the post-operative protocols however are standardized:
Peroperative General anesthesia Paracetamol 1g every 6 h If there are no contra-indications :
anti-inflammatory drugs (ketorolac) 3x/d IV, (including a PPI (proton pump inhibitor) if
necessary) Dexamethasone 0,5 -1 mg/kg Tranexamic acid 1 g Use of a tourniquet by the surgeon
Infiltration of the posterior part of the knee by the surgeon with levobupivacaine 0.2% PCIA
Morphine Femoral nerve block single shot (with 15 ml levobupivacaine 0,25% ) , before the
start of the surgery Postoperative Paracetamol Anti-inflammatory drugs PCIA morphine Ice
application 3 times a day Rescue medication : Tramadol 50 mg, max 6 per day
POD1-POD2 -POD3 During the post operative days patients get passive mobilization of the knee
with the CPM device (Kinetec).
During this exercise patients in the VR-group get a 45 minute VR session and teh Sh-group
gets a 45 min sham session. The physiotherapist (who gets a specific training) or another
investigator will put on the mask. The CPM device starts 10 min after the start of the VR
session. All the patients get standard care, which means they can use their PCIA morphine, as
required.
After each session a blinded investigator measures the VAS pain score, the anxiety score with
the STAY-I questionnaire and the morphine consumed.
On POD3 or on the day of discharge (if earlier) patients will be asked to rate their
satisfaction (with a VAS). The physiotherapist will also rate their appreciation of the
functional rehabilitation, by comparing the increase of passive flexion between POD1 and
POD3.
Total morphine consumption (until POD3) and length of stay will be recorded.
