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

Pain Clinical Trial

— VIREL  

Official title:

Virtual Reality, Experience During Labour; a Qualitative Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04858984
• Other study ID #: NL-METCZ20200096
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: April 2021
• Source: Zuyderland Medisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 1, 2021
• Est. primary completion date: January 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Labor Pain
• Pain
• Virtual Reality

Intervention

Device:
• Virtual Reality
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

Locations

Country	Name	City	State
Netherlands	Zuyderland MC	Heerlen	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	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).