Virtual Reality, Experience During Labour; a Qualitative Research (VIREL) (NCT04858984) | Clinical Trial Compass
CompletedNot Applicable
Virtual Reality, Experience During Labour; a Qualitative Research (VIREL)
Netherlands28 participantsStarted 2020-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patients' VR experience, satisfaction and application preference regarding the guided meditation VR
Timeframe: During labour: directly after the first VR intervention (Guided meditation VR)
2
Patients' VR experience, satisfaction and application preference (meditation or interactive game)
Timeframe: 5 days after labour
3
Patients' VR experience, satisfaction and application preference regarding the interactive game
Timeframe: During labour: directly after the first VR intervention (Interactive game)