Virtual Reality to Reduce Labor Pain

Labor Pain Clinical Trial

— VRH4L  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05167383
• Other study ID #: VRH4L
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: May 30, 2021

Study information

• Verified date: January 2022
• Source: Clinique Saint-Jean, Bruxelles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypnosis
• Labor Pain
• Virtual Reality

Intervention

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.

Locations

Country	Name	City	State
Belgium	Clinique Saint-Jean	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Saint-Jean, Bruxelles

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)