Clinical trial NCT04858984: Virtual Reality, Experience During Labour; a Qualitative Research (VIREL)
Official title: Virtual Reality, Experience During Labour; a Qualitative Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Virtual Reality
Analgesia
Pain
Keywords: Virtual reality
labour pain
analgesia
obstetric care
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Qualitative research
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patients' VR experience, satisfaction and application preference regarding the guided meditation VR
timeFrame: During labour: directly after the first VR intervention (Guided meditation VR)
measure: Patients' VR experience, satisfaction and application preference (meditation or interactive game)
timeFrame: 5 days after labour
measure: Patients' VR experience, satisfaction and application preference regarding the interactive game
timeFrame: During labour: directly after the first VR intervention (Interactive game)
Secondary outcomes:
measure: Labour pain
timeFrame: 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).
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Zuyderland MC
state: Limburg
Study officials:
affiliation: Zuyderland MC
name: Martine Wassen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: