Virtual Reality to Reduce Labor Pain (VRH4L)

Clinique Saint-Jean, Bruxelles

Status: Completed

Conditions: Labor Pain; Hypnosis; Virtual Reality

Treatments: Device: VRH (Virtual Reality Hypnosis); Behavioral: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT05167383

VRH4L

Details and patient eligibility

About

Background and Goal of Study Labor pain remains an area where different analgesia options are looked for, more specifically non-pharmacological remedies are popular. Hypnosis and virtual reality (VR) have been studied with encouraging results. However, until now, the combination of VR and hypnosis (VRH) has not been assessed during labor, although it has shown promising results in other acute pain areas. The VRH4L study will evaluate the efficacy of Virtual Reality Hypnosis (VRH) in reducing pain during labor. Hypnosis is delivered as a standardized therapeutic intervention through virtual reality, using a digital sedation software (AQUA ®, Oncomfort SA).

For this prospective, interventional parallel group, monocentric randomized controlled trial full term women who were planned for an induction of labor at the St-Jean Hospital in Brussels from March to May 2021 were included. Women with complicated pregnancies and patients with contraindications to VR were excluded.

Patients were randomized in two arms. In the VRH group the patients received a 30-minute session of virtual reality hypnosis when in active labor and had access to standard care. Patients in the control group received only standard care.

Primary outcome was the difference in post intervention pain score between the two arms. Secondary outcomes were the difference in pain score 30 minutes after the intervention, vital signs correlated to pain, satisfaction of the experience, interaction with the midwife and prevalence of side effects. Data was analyzed using the student's T test.

Enrollment: 41 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age: ≥ 18 and ≤ 45 years
2. Pregnant with term gestation
3. Willing to adhere to the rules linked to the use of the VRH headset: turning off mobile phone, visit bathroom in advance, no new visitors and no interference of the partner other than when the woman would ask him so
4. Provision of written informed consent
5. Induced labor

Exclusion criteria

1. Complicated pregnancy ( HELLP,...)
2. Scheduled caesarian delivery
3. Receipt of epidural analgesia or opioid painkillers before start active labor phase
4. Low auditory acuity that precludes use of the device
5. Low visual acuity that precludes use of the device
6. Head or face wounds precluding use of the device
7. Schizophrenia
8. Epilepsy
9. Dizziness
10. Non-proficiency in French and/or Dutch (research language)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 2 patient groups, including a placebo group

Intervention VR group

Active Comparator group

Description:

. In the VRH group the patients received a 30-minute session of virtual reality hypnosis when in active labor and had access to standard care.

Treatment:

Behavioral: Standard care

Device: VRH (Virtual Reality Hypnosis)

Standard treatment

Placebo Comparator group

Description:

Patients in the control group received only standard care.

Treatment:

Behavioral: Standard care