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Labor PainNCT05879848

VR Scenario for Labor Pain Control

A study testing VR in people with Labor Pain, run by Federico II University at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Labor Pain
What is being tested?
VR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteItaly
Study dates
1 Nov 2021to 31 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Single term pregnancy;
  • Full term physiological pregnancy;
  • Active phase of labor;
  • Spontaneous labor;
  • Nulliparous between 37 and 42 weeks of gestation with cephalic presentation;
  • Maternal age between 18 and 45 years.

Who cannot join

  • Twin pregnancy;
  • Preterm labor;
  • Preterm rupture of amnio membranes;
  • Fetal abnormalities;
  • Intrauterine growth restriction;
  • Post-term pregnancy;
Show all 13Show fewer
  • Women with impaired consciousness, seriously ill, mentally disabled;
  • Women under the age of 18 or over the age of 45;
  • Women with visual and/or auditory impairments;
  • Women prone to seizures;
  • Women with a predisposition to motion sickness;
  • Refusal to sign informed consent;
  • Previous cesarean section.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • University Federico II

    Naples, 80131

Other trials in Italy

About this study

Official title: Synchronization of a VR Scenario to Uterine Contractions for Labor Pain Management: Development Study and Randomized Controlled Trial

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.

Read the detailed 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.

Conditions
Labor Pain
Being tested
VR
Medical subject headings
Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VROther

    virtual reality scenario synchronized with the uterine contractions

Study groups in NCT05879848
Study groupRoleWhat they receive
Experimental analgesic treatment (VR)ExperimentalAchieved active labor and regular contractions (>= 4 contractions in 10 minutes), patients are given the virtual reality scenario synchronized with the uterine contractions , and no other alternative analgesia is provided, except for the midwife's support.
Receives: Other: VR
Standard Care (non-VR)No interventionPatients in active labour. undergo standard care (only midwife's support, no analgesia)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective pain

    numerical rating scale for pain

    Measured: 1 year

Secondary outcomes (6)
  1. NAUSEA

    numerical rating scale for nausea

    Measured: 1 year

  2. Objective pain via wristband

    heart rate measurement

    Measured: 1 year

  3. incidence of episiotomy and lacerations

    incidence of episiotomy and lacerations

    Measured: 1 year

  4. epidural anesthesia

    incidence of epidural anesthesia

    Measured: 1 year

  5. incidence of operative delivery

    incidence of use of vacuum extractor

    Measured: 1 year

  6. neonatal outcome

    APGAR score at 5 and 10 minutes

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2023
  2. Study start1 Nov 2021
  3. Primary completion30 Jun 2022
  4. Study completion31 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05879848
Sponsor's protocol ID
FEDIIU485/20
Status last verified
May 2023
First submitted
2 Apr 2023
Last updated
30 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing VR in people with Labor Pain, run by Federico II University at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective pain (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.

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