Investigating the Effect of Virtual Reality on Labour Analgesia Use

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

Interventions

DEVICE

PICO glasses and controller with BirthVR

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)

Sponsors & Collaborators

• Diakonessenhuis, Utrecht

  collaborator OTHER

• Zuyderland Medisch Centrum

  lead OTHER

Principal Investigators

• Martine Wassen, M.D. · Zuyderland MC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-06-17

Primary Completion

2023-07-01

Completion

2023-09-01

Countries

• Netherlands

Study Locations