Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05879848 |
| Other study ID # |
FEDIIU485/20 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2021 |
| Est. completion date |
July 31, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
Federico II University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The present study aims to evaluate Virtual Reality analgesic interventions for active labor
with biofeedback-based Virtual Reality technologies synchronized to uterine activity. The
investigators developed a Virtual Reality system modeled on uterine contractions by
connection to a cardiotocographic equipment. The present study, based on a multidisciplinary
approach, comprised the following phases: 1)development of hardware and software components;
2) design of the Reality scenario through a qualitative focus group discussion study; 3)
clinical trial on a sample of 53 cases and 53 controls during active labor.
Description:
Labor is described as one of the most painful events women can experience throughout their
lives. A severe labor pain can have long lasting effects, as a severe labor can affect
breastfeeding and is associated with an increased risk of postpartum depression. The current
gold standard for labor pain management is pharmacological pain management techniques.
However, their application is still flawed by its invasiveness, potential collateral effects,
and financial. Consequently,researchers have investigated the role of complementary and
alternative medicine in reducing labor pain like Virtual reality, that is a technology that
allows users to immerse themselves in a three dimensional computer-generated scenario. At
present, many studies have tested Virtual Reality interventions for the pain management of
chemotherapy infusions, acute burn injuries, cancer-related and, recently, labor pain. The
present study aimed to develop a biofeedback-implemented Virtual Reality scenario through
algorithm-based cardiotocographic pattern processing that can effectively reduce labor
anxiety and fear of labor and generally induce a positive emotional state during use.
Materials and Methods:
The study relied on a multidisciplinary team involving a psychologist, a gynecologist, three
software engineers, a midwife, and a psychiatry resident to develop a biofeedback implemented
Virtual Reality system. The interdisciplinary team conducted brainstorming sessions and
discussed the development of the new system in light of the previous literature on the topic.
System development: the functioning of the developed system and its components. Hardware
components: 1) Fetal monitor: Philips Avalon 2) Philips Avalon Fetal and Maternal Cableless
Pod 3)Oculus Quest 2 Virtual Reality head-mounted display 4) Windows. Software components: 1)
Medicollector SERVICE 2) Steam Virtual Reality 2.0. The system hardware architecture involves
using the Meta Quest 2 head mounted display to immerse patients in a relaxing environment.
Since the rendering of the virtual environment is performed on a computer, the investigators
realize a more complex environment than what would have been possible by exploiting the
computing capacity of the Head Mounted Display exclusively. However, in the system
architecture, using a computer is due to two main reasons: i) to enable obstetricians to
monitor the activities of laboring women and ii) to acquire physiological data from the
cardiotocograph bonded to the patient. On this last one, the computer is physically connected
to the cardiotocograph. Specifically, a Philips fetal monitor was used. The monitor is
connected to the computer via a network cable and an adapter. The system prototype was
developed using Unity 2019.4.14 and Steam Virtual Reality 2.0. Unity, one of the most popular
cross-platform graphics engines for developing Virtual Reality applications, was used to
create the virtual environment. The Steam Virtual Reality tool simplifies experiencing the
Virtual Reality environment on the chosen Head Mounted Display. The fetal monitor data
acquisition relies on the Medicollector software, executed on the computer, and the final
application responsible for rendering the virtual environment and transmitting to the Head
Mounted Display. Medicollector provides to access cardiotocography data, which can be used to
access the fetal heart rate and uterine contractions for adapting the scenario each time a
peak in the uterine contractions is detected.
Qualitative focus group discussion study: The scenario design resulted from a series of focus
group sessions moderated by the psychologist of the multidisciplinary team. The second author
was an observer attending the meetings and collecting notes. The volunteers were selected
from women who had given birth at University Hospital "Federico II" of Naples. A total of 12
mothers were recruited and randomly assigned to three focus groups, each consisting of four
mothers. After informed consent was obtained, the date and time of the meetings were
arranged. Discussions took place between March and April 2021. The three focus groups lasted
89, 92, and 97 minutes and involved a semi-structured discussion divided into two parts. In
the first part of the sessions, women were invited to discuss their childbirth experiences,
their pain, and what helped them endure the contractions. In the second phase, after
explaining the developed system and the purpose of the designed experimental intervention,
women were invited to discuss how participants would imagine a virtual scenario that could
have helped them relax and better stand the labor pain. Developed Virtual Reality scenario:
The developed scenario involves a tropical beach lined with palm trees, surrounded by green
mountains, and bathed by a calm sea. In the subject's immediate surroundings, an interactive
virtual element was placed: a drum that could be played through the use of controllers. In
addition, the scenario reproduced elements present in the actual labor room: the patient's
bed and a cardiotocograph. The patient's bed position in the system reflected that of the
real bed in the labor room, so users could reach the bed while wearing the Head Mounted
Display. The cardiotocograph monitor was introduced into the environment so that patients
could visually access the clinical parameters acquired by the cardiotocograph. During
contractions, a flock of storks can be seen in the distance flying toward the subject's point
of view. These have been placed in the environment with a twofold purpose: i) as a
propitiatory message and ii) as a distracting element adaptive to the intensity of the
detected uterine contractions. The adaptive system module displays the flock of storks in the
virtual environment after detecting an incoming peak value of uterine contraction.
Furthermore, in the scenario realized, when the storks are in flight, the storks can be
attracted to the user's position by repeatedly playing the drum. If deemed appropriate or
desired by the user, this element could also be activated manually by the medical and
obstetrical staff via the computer keyboard. Intervention: Subjects randomly assigned to the
intervention group were provided a Virtual Reality headset. Once active labor and pain
intensity of regular contractions of 4/10 is reached, the virtual reality scenario
synchronized to the uterine contractions is administered. During the procedure, no
alternative analgesia methods are provided beside the continuous physical presence and vocal
support of obstetric personnel. Immediately before and after using the headset, patients fill
out the required questionnaires and scales.
