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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Virtual Reality, Experience During Labour; a Qualitative Research

Conditions
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Pain, Labor Pain, Virtual Reality, Analgesia

Intervention / Treatment
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* Device: Virtual Reality


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Qualitative research
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality group<br>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. | Device: Virtual Reality<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' VR experience, satisfaction and application preference regarding the 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) | 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 | 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 | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality, labour pain, analgesia, obstetric care