Clinical trial NCT05167383: Virtual Reality to Reduce Labor Pain
Official title: A Prospective Randomized Controlled Monocentric Study Evaluating the Impact of Virtual Reality Hypnosis During Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Virtual Reality
Hypnosis
Keywords: non-pharmacological analgesia
Lead sponsor: Clinique Saint-Jean, Bruxelles
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective interventional Randomized Controlled Trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Post interventional pain scores
timeFrame: T1(before intervention) and T3 (directly after intervention)
Secondary outcomes:
measure: Pain 30 minutes after intervention
timeFrame: T4 (30 min after intervention)
measure: Maternal heart rate
timeFrame: T1(before intervention) , T2 (During intervention), T3 (directly after intervention) and T4 (30 min after intervention)
measure: Nausea
timeFrame: T1(before intervention) , T3 (directly after intervention) and T4 (30 min after intervention)
measure: Satisfaction of the mother
timeFrame: T6 (day 1 postpartum)
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Clinique Saint-Jean
Study officials:
affiliation: Resident Anesthesiologie
name: Louise Piccart, Dr.
role: STUDY_CHAIR
References: