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NCT04992663: DELIVR
Investigating the Effect of Virtual Reality on Labour Analgesia Use
NA trial testing PICO glasses and controller with BirthVR in Virtual Reality in 372 participants. Status unknown.
1 July 2023
Quick facts
| Lead sponsor | Zuyderland Medisch Centrum |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 372 |
| Start date | 17 June 2021 |
| Primary completion | 1 July 2023 |
| Estimated completion | 1 September 2023 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- PICO glasses and controller with BirthVR
Conditions studied
- Virtual Reality — all drugs for Virtual Reality →
- Labor Pain — all drugs for Labor Pain →
- Labor Analgesia — all drugs for Labor Analgesia →
Sponsor
Zuyderland Medisch Centrum — full company profile →
Who can join
18 and older, female only, with Virtual Reality or Labor Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 pain. The implementation of alternative methods like VR to reduce labour pain can contribute to reduce the use of pharmacological pain management methods and associated side effects. The objective of this study is to asses the effect of VR on the request for labour analgesia compared with standard care. Secondary objectives are the effect of VR on; the referral rate from midwifery led first line care to second line obstetrical care, patient satisfaction of VR use, delivery expectancy and experience (WIDEQ-A and WIDEQ-B), patient reported outcome measures (PROMs) and patient reported experience measure (PREMs) as defined by international consortium for health outcome measures (ICHOM) and evaluate the social, economic, organizational and ethical issues of VR by using the health-technology assessment analysis (HTA). Study design: The study concerns a non-blinded, single centre, randomised controlled trial Study population: Nulliparous and multiparous women with a singleton in cephalic presentation beyond 36+0 weeks' gestation and an intention for vaginal delivery. The study population will be randomly assigned to the intervention group (VR-group) or the care as usual group. The intervention group will be exposed to an immersive guided relaxation VR experience (BirthVR) during labour. If a woman in the intervention group requires additional pharmacological pain relief, this will be offered according to the local protocol. The participants who are randomised to the standard care group receive labour pain analgesia on maternal request according to the local usual standard care.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04992663
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04992663 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zuyderland Medisch Centrum
- Last refreshed: 5 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04992663.
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