Virtual Reality to Reduce Labor Pain

NCT ID: NCT05167383

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-05-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention VR group

. 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.

Group Type: ACTIVE_COMPARATOR

VRH (Virtual Reality Hypnosis)

Intervention Type: DEVICE

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

Standard care

Intervention Type: 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.

Standard treatment

Patients in the control group received only standard care.

Group Type: PLACEBO_COMPARATOR

Standard care

Intervention Type: 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.

Interventions

VRH (Virtual Reality Hypnosis)

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

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Clinique Saint-Jean, Bruxelles

OTHER

Sponsor Role: lead

Responsible Party

Dr. Arnaud Bosteels

Medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louise Piccart, Dr.

Role: STUDY_CHAIR

Resident Anesthesiologie

Locations

Clinique Saint-Jean

Brussels, , Belgium

Countries

Belgium

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

VRH4L

Identifier Type: -

Identifier Source: org_study_id