Virtual Reality, Experience During Labour; a Qualitative Research (VIREL) (VIREL)

April 21, 2021 updated by: Anne-Claire Musters, Zuyderland Medisch Centrum

Virtual Reality, Experience During Labour; a Qualitative Research

Childbirth is associated with labour pain and can be regarded as one of the most serious kinds of pain. Labour pain management methods include pharmacological and non-pharmacological methods. There is increasing evidence that virtual reality (VR) is effective in the reduction of labour pain.

The aim of this qualitative study is to explore the experience, preference, and satisfaction of the use of two different VR scenario's during labour. The secondary outcome parameter is the effect of VR on pain reduction and anxiety during labour, measured by NRS score.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Epidural Analgesia (EA) has been regarded as the most effective method of labour analgesia. Pharmacological analgesia methods are known to have adverse side effects, such as nausea, vomiting and drowsiness in parental opioids; pruritus, nausea, desaturation, respiratory depression and apnea in patient-controlled remifentanil analgesia; and maternal fever, maternal hypotension and urinary retention in EA. Furthermore, routine EA is likely resulting in more operative deliveries. Considering these possible adverse effects, it is worth exploring alternative methods for labour pain relief.

There is increasing evidence that virtual reality (VR) is effective in the reduction of labour pain.

This VIREL study aims to examine the experience, preference, and satisfaction of VR in women during labour. The study is set up as a single centre, qualitative study in a non-university teaching hospital in The Netherlands with 2800 deliveries annually. Participants will experience an immersive guided relaxation VR (VR1) and an interactive game (VR2) during labour. VR1 consists of a video of an exotic location guided by the sound of the waves and a calm English-speaking voice. VR2 requires women to use the controller to throw snowballs in order to catch presents and reach the next level. Patients are allowed to stop using the VR at any moment during the intervention.

When the participant is declared to be in labour, defined as having regular painful uterine contractions, cervical effacement and at least 3cm dilatation, VR1 will be offered for ten minutes. Before and immediately after VR1, the patient is asked to fill out a Numeric Rating Scale (NRS) score for pain.

During the 30-minute intermission after VR1 the patient fills out the post-intervention questionnaire regarding VR1. Subsequently, VR2 is offered for ten minutes. Before and immediately after VR2 the patient filled in the NRS score for pain, and the patient completed a post-intervention questionnaire regarding VR2. Additional use of VR is allowed by maternal request. Five days post-partum all participants who completed both VR interventions will be contacted by telephone for a semi-structured interview.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Limburg
      • Heerlen, Limburg, Netherlands, 6401 CX
        • Zuyderland MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Written and orally given informed consent
  • 18 years and older
  • Native Dutch speaker
  • Pregnant of a singleton in cephalic presentation
  • Intention to deliver vaginally
  • Induced labour by a balloon or artificial rupture of membranes

Exclusion Criteria:

  • Chronic pain patients; defined as 'persistent or recurrent pain lasting longer than 3 months'. The pain is not due to the gynecological problem.
  • Chronical use of pain medication (opioids)
  • Alcohol or drug abuse
  • Known car sickness or susceptibility to motion sickness
  • Epileptic insults in previous history
  • Psychotically seizures in previous history
  • Claustrophobic
  • Blindness
  • History of mental illness
  • Severe hearing or vision deficits
  • Epidural Anesthesia during labour

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality group

All participants experienced an immersive guided meditation virtual reality (VR1) and an interactive game virtual reality (VR2) experience during labour. Both VR interventions were offered for 10 minutes. Before and immediately after an intervention, the patient was asked to fill out a Numeric Rating Scale (NRS) score for pain.

During the 30-minute intermission after the VR intervention the patient completed the post-intervention questionnaire.

VR1 consisted of a video of an exotic location guided by the sound of the waves and a calm English-speaking voice. VR2 required women to use the controller to throw snowballs in order to catch presents and reach the next level. Patients were allowed to stop using the VR at any moment during the intervention.

Five days post-partum all participants who completed both VR interventions were contacted by telephone for an interview.

A portable, standalone VR headset called Oculus Go (Facebook Technologies, LLC. 1601 Willow Road, Menlo Park, CA 940250) with a head-mounted display with built in audio drivers was used. Disposable hygiene masks and a surgical cap were used as an underlay below the headset an

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' VR experience, satisfaction and application preference regarding the guided meditation VR
Time Frame: During labour: directly after the first VR intervention (Guided meditation VR)

A patients' VR experience, satisfaction and application preference was examined using a post-intervention questionnaire.

A short post intervention questionnaire, intended to provide a first feedback about the experience and preference of the VR application the patient used a few minutes ago. Ratings varied of very pleasant (+5) versus very unpleasant (0) and very much (+5) versus not at all (0).

Theme's: General experience of VR1 (meditation) / VR2 (game), the amount of distraction, feeling of anxiety during VR1 (meditation) / VR2 (game), reusing VR1 (meditation) / VR2 (game), preference of environment (beach environment or do you prefer something else?), side effects.

During labour: directly after the first VR intervention (Guided meditation VR)
Patients' VR experience, satisfaction and application preference (meditation or interactive game)
Time Frame: 5 days after labour

A patients' VR experience, satisfaction and application preference was examined using a semi-structured interview.

Theme's of the semi-structured interview:

1. VR experience

  • General experience
  • VR1 experience
  • VR2 experience
  • Side effects
  • Reusing VR
  • Recommendation to other women
  • Improvements

    2 Pain reduction

  • Pain intensity
  • Pain perception
  • Distraction

    3 Usability VR application

  • VR application
  • Comfort of VR glasses
5 days after labour
Patients' VR experience, satisfaction and application preference regarding the interactive game
Time Frame: During labour: directly after the first VR intervention (Interactive game)

A patients' VR experience, satisfaction and application preference was examined using a post-intervention questionnaire.

A short post intervention questionnaire, intended to provide a first feedback about the experience and preference of the VR application the patient used a few minutes ago. Ratings varied of very pleasant (+5) versus very unpleasant (0) and very much (+5) versus not at all (0).

Theme's: General experience of VR1 (meditation) / VR2 (game), the amount of distraction, feeling of anxiety during VR1 (meditation) / VR2 (game), reusing VR1 (meditation) / VR2 (game), preference of environment (beach environment or do you prefer something else?), side effects.

During labour: directly after the first VR intervention (Interactive game)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Labour pain
Time Frame: 4 moments during labour: Before the first VR intervention (meditation), directly after the first VR intervention (meditation). Before the second VR intervention (game), directly after the second VR intervention (game).
Labour pain before and directly after VR was evaluated using the Numeric (pain) rating scale (The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).)
4 moments during labour: Before the first VR intervention (meditation), directly after the first VR intervention (meditation). Before the second VR intervention (game), directly after the second VR intervention (game).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Martine Wassen, M.D., Zuyderland MC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

January 12, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

April 11, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL-METCZ20200096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available at the moment. The study protocol, statistical analysis plan and informed consent form will be available after publication of the article.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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