Virtual Reality to Reduce Labor Pain

NCT05167383 | Completed

• 1 other identifier: VRH4L
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain; Virtual Reality; Hypnosis

Keywords

non-pharmacological analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain 30 minutes after intervention

  T4 (30 min after intervention)

• Maternal heart rate

  T1(before intervention) , T2 (During intervention), T3 (directly after intervention) and T4 (30 min after intervention)

• Nausea

  T1(before intervention) , T3 (directly after intervention) and T4 (30 min after intervention)

• Satisfaction of the mother

  T6 (day 1 postpartum)

Study Arms (2)

Intervention VR group

ACTIVE COMPARATOR

. 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

Standard treatment

PLACEBO COMPARATOR

Patients in the control group received only standard care.

Behavioral: Standard care

Interventions

VRH (Virtual Reality Hypnosis) DEVICE

Hypnosis is delivered as a standardized therapeutic intervention through virtual reality, using a digital sedation software (AQUA ®, Onfomfort SA).

Intervention VR group

Standard care BEHAVIORAL

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.

Intervention VR group; Standard treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: ≥ 18 and ≤ 45 years
• Pregnant with term gestation
• 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
• Provision of written informed consent
• Induced labor

You may not qualify if:

• Complicated pregnancy ( HELLP,…)
• Scheduled caesarian delivery
• Receipt of epidural analgesia or opioid painkillers before start active labor phase
• Low auditory acuity that precludes use of the device
• Low visual acuity that precludes use of the device
• Head or face wounds precluding use of the device
• Schizophrenia
• Epilepsy
• Dizziness
• Non-proficiency in French and/or Dutch (research language)

Sponsors & Collaborators

• Clinique Saint-Jean, Bruxelles: lead

Study Sites (1)

Clinique Saint-Jean

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Louise Piccart, Dr.

  Resident Anesthesiologie

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator only gets the anonymized prospective data from the patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: Prospective interventional Randomized Controlled Trial

Study Record Dates

• First Submitted: November 6, 2021
• First Posted: December 22, 2021
• Study Start: March 1, 2021
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: end 2021- begin 2022

Locations

BE (1)