Virtual Reality to Reduce Labor Pain (VRH4L)

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

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain; Hypnosis; Virtual Reality
• Intervention / Treatment: Device: VRH (Virtual Reality Hypnosis); Behavioral: Standard care

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1000
    • Clinique Saint-Jean

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention VR group; . 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); Hypnosis is delivered as a standardized therapeutic intervention through virtual reality, using a digital sedation software (AQUA ®, Onfomfort SA).; Behavioral: Standard care; 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.
Placebo Comparator: Standard treatment; Patients in the control group received only standard care.	Behavioral: Standard care; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Clinique Saint-Jean, Bruxelles
• Investigators: Study Chair: Louise Piccart, Dr., Resident Anesthesiologie

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: November 6, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: non-pharmacological analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: VRH4L

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publication of abstract (Poster on the ESA 2021) and Study Report (Paper in the Acta Belgica, end of 2021)
• IPD Sharing Time Frame: end 2021- begin 2022
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No