A randomised controlled trial investigating the effect of virtual reality on labour analgesia use

Labour pain is the result of many complex interactions and can be regarded as
one of the most serious kinds of pain. During labour, 80-90% of the women
experience pain of which 65-68% rated labour pain as severe or extremely
severe. Labour pain management strategies include non-pharmacological and
pharmacological interventions. Pharmacological methods for pain relief during
labour include inhaled analgesia (Entonox; N2O), opioids, non-opioids drugs,
local anaesthetic nerve blocks, and epidural and intrathecal injections of
local anaesthetics or both. Epidural analgesia (EA) is the most effective
method for pain relief during labour.
In 2019, 33% of the women in The Netherlands received EA during labour.
Unintended adverse effects also accompany EA, like maternal fever, hypotension,
urinary retention, motor blockade and routine EA is likely to lead to more
operative deliveries. Remifentanil patient-controlled analgesia
(remifentanil-PCA) has also been frequently (18%) used as pain relief during
labour in The Netherlands [perined 2019]. Possible side effects of remifentanil
are pruritus, nausea, hyperalgesia, desaturation, respiratory depression and
apnea.
Relatively common (well-known) non-pharmacological interventions for pain
relief are continuous psychological support, alternating positions during
labour, intracutaneous or subcutaneous sterile water injections, transcutaneous
electrical nerve stimulation, hypnosis, biofeedback, immersion in water,
aromatherapy, relaxation techniques (yoga, audio, music), acupuncture or
acupressure and manual methods (massage, reflexology). An alternative, at the
moment not common, non-pharmacological method is the use of virtual reality
(VR).
Taking into account the safety and possible adverse effects of current
pharmacological pain relief during labour, it is worth exploring VR as a
non-pharmacological pain relief to avoid the possible side effects of
pharmacological methods for pain relief and decrease health care costs.
VR is an upcoming technology used within healthcare, which makes use of the
principle of distraction. Pain perception is strongly affected by psychological
factors.
The Neuromatrix Theory of Pain states that pain is a multidimensional
experience, consisting of affective, sensory and cognitive components. The
perception of pain is thought to be related to the amount of attention that is
given to pain stimuli.
Recently a systematic review and meta-analysis showed VR to be an effective
method to reduce acute pain. There is limited evidence of the use of VR during
labour. An observational study investigated the effect of music in 62 women
during labour and showed a significant reduction of pain and anxiety. In the
VRAIL pilot study, a preliminary randomised controlled trial, 28 women in
labour were enrolled. This study showed a significant decrease in pain and
anxiety during labour in the VR-group. This preliminary and scarce literature
suggests that VR is a potentially effective technique for improving pain and
anxiety during labour. VR can be used as a safe, non-invasive, analgesic
method, without risks of drug addiction and minimal side effects.
A recent qualitative study (VIREL) investigated the experience and preference
and the effect on pain intensity during labour of interactive and passive
virtual reality distraction. Women experienced less pain during meditation VR
use and preferred the guided meditation VR during labour.

In this study, we want to investigate the effect of meditation VR (BirthVR) on
the request for labour analgesia. We hypothesize that VR will reduce the
request for labour analgesia and reduce the rate of referral rate from
midwifery led first line care to second line obstetrical care.

The aim of this study is to investigate whether VR will decrease the request
for labour analgesia.

Primary outcome measure:
* Request for labour analgesia

Secondary outcome measures:
* Patient tolerability, feasibility and satisfaction of VR use
(VR-questionnaire, WDEQ-A and WDEQ-B)
* Patient reported outcome measures (PROM) and patient reported experience
measure (PREM) as defined by international consortium for health outcome
measures (ICHOM)
* Labour complications, neonatal parameters

The study concerns a non-blinded multi centre, randomised controlled trial
(RCT).
Eligible patients will be randomised to either the VR group or standard care
group. In addition to the standard care, the VR group receives a VR information
moment during labour and the possibility to exercise with the VR glasses and
they receive VR during labour from the moment they are in active labour and use
VR as much as they prefer. Our hypothesis is that using *BirthCoach VR* during
labour will result in a 15% decrease in the request for labour analgesia. In
general multiparous women less often receive medicinal pain relief than
nulliparous women. This statement is also supported by national and local data.
This difference in incidence results in a different effect size. For this
reason, two separate sample sizes for multi- and nulliparous have been
calculated

BirthVR tool; a virtual reality app consisting of nature environments with a
guided meditation.

VR is a new technique for labour pain reduction. We performed a qualitative
study (VIREL) in 23 women during labour to explore the feasibility of VR. This
study showed a reduction of pain measured on the visual analogue scale (VAS) of
19 mm after the use of VR during labour. There were no adverse events after the
use of VR during labour. They can experience side-effects of VR for example
dizziness or nausea.