Virtual Reality to Reduce Labor Pain

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomized Controlled Monocentric Study Evaluating the Impact of Virtual Reality Hypnosis During Labor

Conditions
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Labor Pain, Virtual Reality, Hypnosis

Intervention / Treatment
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* Device: VRH (Virtual Reality Hypnosis)
* Behavioral: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: ≥ 18 and ≤ 45 years Pregnant with term gestation 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 Provision of written informed consent Induced labor Exclusion Criteria: Complicated pregnancy ( HELLP,…) Scheduled caesarian delivery Receipt of epidural analgesia or opioid painkillers before start active labor phase Low auditory acuity that precludes use of the device Low visual acuity that precludes use of the device Head or face wounds precluding use of the device Schizophrenia Epilepsy Dizziness Non-proficiency in French and/or Dutch (research language)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective interventional Randomized Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention VR group<br>. 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. | Device: VRH (Virtual Reality Hypnosis)<br>* Hypnosis is delivered as a standardized therapeutic intervention through virtual reality, using a digital sedation software (AQUA ®, Onfomfort SA).<br>Behavioral: Standard care<br>* The standard treatment (ST) for labor pain as used in our hospital contains massage, aquatherapy and postural exercises. This is always available for any woman in labor.<br>|
| Placebo Comparator: Standard treatment<br>Patients in the control group received only standard care. | Behavioral: Standard care<br>* The standard treatment (ST) for labor pain as used in our hospital contains massage, aquatherapy and postural exercises. This is always available for any woman in labor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post interventional pain scores | Primary outcome was the difference in post intervention pain score between the two arms. Difference in Numerical Rating Scale (0 to 10, where 0 is no pain and 10 is maximum pain) pain scores after the intervention between the VRH and Standard care group. | T1(before intervention) and T3 (directly after intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain 30 minutes after intervention | Measure of Numerical Rating Scale (0 to 10, where 0 is no pain and 10 is maximum pain) after 30 minutes | T4 (30 min after intervention) | 
| Maternal heart rate | Measured heart rate during and after intervention as an absolute value. | T1(before intervention) , T2 (During intervention), T3 (directly after intervention) and T4 (30 min after intervention) | 
| Nausea | Nausea and vomiting scores (0-3, 0 = no nausea, 3= nausea and vomiting)) | T1(before intervention) , T3 (directly after intervention) and T4 (30 min after intervention) | 
| Satisfaction of the mother | Likert scale (-2,0,2) .-2 is very dissatisfied, 1= dissatisfied, 0= not satisfied, nor dissatisfied, 1= satisfied and 2 is very satisfied | T6 (day 1 postpartum) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-pharmacological analgesia