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

Not Applicable

Completed

• Conditions: Pain; Virtual Reality; Analgesia; Labor Pain
• Interventions: Device: Virtual Reality

• Registration Number: NCT04858984
• Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary

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

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 Timeline

• Study Start: 2020-07-01
• Primary Completion: 2021-01-12
• Study Completion: 2021-03-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-11
• Study First Submitted QC: 2021-04-21
• Last Update Submitted: 2021-04-21
• Study First Posted: 2021-04-26
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual reality group	Virtual Reality	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.

Primary Outcome Measures

Name	Time	Method
Patients' VR experience, satisfaction and application preference regarding the interactive game	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.
Patients' VR experience, satisfaction and application preference (meditation or interactive game)	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
Patients' VR experience, satisfaction and application preference regarding the guided meditation VR	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.

Secondary Outcome Measures

Name	Time	Method
Labour 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).	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).)

Trial Locations

Locations (1)

Zuyderland MC; 🇳🇱 Heerlen, Limburg, Netherlands