An interventional study of VRH (Virtual Reality Hypnosis) and Standard care in Labor Pain, Virtual Reality and Hypnosis, sponsored by Clinique Saint-Jean, Bruxelles. Completed at 1 site in Belgium. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-18.
Sponsored by Clinique Saint-Jean, Bruxelles · Not applicable, Interventional, and Treatment
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.
396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.
This study's enrollment of 41 is below the median of 100 across 326 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →Clinique Saint-Jean, Bruxelles is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
. 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) · Behavioral: Standard care
Patients in the control group received only standard care.
Behavioral: Standard care
Hypnosis is delivered as a standardized therapeutic intervention through virtual reality, using a digital sedation software (AQUA ®, Onfomfort SA).
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.
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.
Time frame: T1(before intervention) and T3 (directly after intervention)
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
Time frame: T4 (30 min after intervention)
Maternal heart rate
Measured heart rate during and after intervention as an absolute value.
Time frame: 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))
Time frame: 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
Time frame: T6 (day 1 postpartum)
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Publication of abstract (Poster on the ESA 2021) and Study Report (Paper in the Acta Belgica, end of 2021)
Supporting information: Csr
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Clinique Saint-Jean, Bruxelles