Virtual Reality to Reduce Labor Pain

Not Applicable

Completed

• Conditions: Labor Pain; Virtual Reality; Hypnosis
• Interventions: Behavioral: Standard care; Device: VRH (Virtual Reality Hypnosis)

• Registration Number: NCT05167383
• Lead Sponsor: Clinique Saint-Jean, Bruxelles

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30
• Study First Submitted: 2021-11-06
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-22
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment	Standard care	Patients in the control group received only standard care.
Intervention VR group	Standard care	. 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.
Intervention VR group	VRH (Virtual Reality Hypnosis)	. 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.

Primary Outcome Measures

Name	Time	Method
Post interventional pain scores	T1(before intervention) and T3 (directly after intervention)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinique Saint-Jean; 🇧🇪 Brussel, Belgium