Investigating the Effect of Virtual Reality on Labour Analgesia Use

NCT04992663 | Unknown DMC

• 1 other identifier: METCZ20210037
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Virtual Reality; Labor Pain; Labor Analgesia

Keywords

Virtual Reality; Analgesia; Labor Pain

Outcome Measures

Primary Outcomes (1)

• Change of request for pharmacological analgesia by women in labour

  Any pharmacological analgesia received during labour? Yes or no.

  From the start of labour (contraction or spontaneous rupture of membranes) until start pushing (expulsion phase)

Secondary Outcomes (5)

• The referral rate from midwifery led first line care to second line obstetrical care based on pharmacological analgesia request during labour

  From the start of labour (contraction or spontaneous rupture of membranes) until start pushing (expulsion phase)

• Delivery expectancy and experience (WDEQ-A and WDEQ-B)

  WDEQ-A (at 36week pregnancy), WDEQ-B (1-7 days post partum)

• Patient satisfaction of VR use and the application BirthVR (questionnaire)

  1-7 days post partum

• Patient reported outcome measures (PROMs) as defined by ICHOM

  AD 36weeks, 1-7 days post partum, 6 weeks post partum and 6 months post partum

• Patient reported experience measure (PREMs) as defined by ICHOM

  AD 36weeks, 1-7 days post partum, 6 weeks post partum and 6 months post partum

Study Arms (2)

Intervention group (VR-group)

EXPERIMENTAL

The participants randomised into this group are offered the BirthVR intervention during Labour. The VR group receives a VR information moment during labour and the possibility to exercise with the VR glasses and they receive VR during labour from the moment they are in active labour and use VR as much as they prefer. After labour, participants of the VR-group receive a structured questionnaire in which tolerability, feasibility and satisfaction of VR use is evaluated and participants receive the WDEQ-B questionnaire and PROM and PREM (ICHOM; T3, T4, T5). As soon as VR does not serve as adequate pain relief during labour and a women requests additional pain medication this will be offered according to local protocol.

Device: PICO glasses and controller with BirthVR

Care as usual group

NO INTERVENTION

Patients randomised to the care as usual group will be offered pain medication during labour according to the local protocol, and on maternal request only. Postpartum participants receive the WDEQ-B questionnaire and PROM and PREM (ICHOM; T3, T4, T5)

Interventions

PICO glasses and controller with BirthVR DEVICE

PICO glasses will be used for VR in the intervention group. BirthVR is a guided meditation VR application designed by qualitative research (VIREL study) performed by this study group. The BirthVR application contains the following components: * Information/introduction video (including a virtual reality tour through the labour ward of the Zuyderland MC) * Fase 1: Beach environment, guided meditation/breathing exercise (1 session: 25 minutes) * Fase 2: Underwater environment, guided meditation/breathing exercise (1 session: 25minutes) * Fase 3: Mountain environment, breathing technique exercise on demand by using the controller (1 session: 30 minutes) * Counseling video (cesarean section, epidural anesthesia)

Intervention group (VR-group)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written and orally given informed consent
• years and older
• Native Dutch speaker
• Singleton pregnancy
• Nulliparous or multiparous women
• cephalic presentation
• +0 weeks gestation
• Intention for a vaginal delivery
• Under care of Zuyderland hospital or one of the first line midwifery practices participating in the Verloskundig Samenwerkings Verband (VSV) Zuyderland

You may not qualify if:

• Chronic pain patients defined as 'persistent or recurrent pain lasting longer than 3 months. The pain is not due to an obstetrical problem.
• Chronic use of pain medication (opioids)
• Alcohol or drug abuse
• Known car sickness
• Epileptic insults in previous history
• Psychotically seizures in previous history
• Claustrophobic
• Visual impairment
• History of mental illness
• Patients in strict isolation (MSRA)
• Age \<18 years
• Twin pregnancy

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead
• Diakonessenhuis, Utrecht: collaborator

Study Sites (1)

Zuyderland MC

Heerlen, Limburg, 6401 CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Labor Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Martine Wassen, M.D.

  Zuyderland MC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Claire Musters, M.D.

CONTACT

088-4597777; a.musters@zuyderland.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-blinded, starting as single centre, randomised controlled trial (RCT). After implementation of the DELIVR trial in the Zuyderland MC, the study will be expanded as a multi centre trial.

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: August 5, 2021
• Study Start: June 17, 2021
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)