Labor PainVRH4LNCT05167383
Virtual Reality to Reduce Labor Pain
A study testing VRH (Virtual Reality Hypnosis) in people with Labor Pain and Virtual Reality, run by Clinique Saint-Jean, Bruxelles at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Virtual Reality, Hypnosis
- What is being tested?
- VRH (Virtual Reality Hypnosis)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2021to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- Schizophrenia
- Epilepsy
- Dizziness
- Non-proficiency in French and/or Dutch (research language)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Monocentric Study Evaluating the Impact of Virtual Reality Hypnosis During Labor
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.
Read more
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
- Being tested
- VRH (Virtual Reality Hypnosis), Standard care
- Keywords
- non-pharmacological analgesia
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRH (Virtual Reality Hypnosis)Device
Hypnosis is delivered as a standardized therapeutic intervention through virtual reality, using a digital sedation software (AQUA ®, Onfomfort SA).
Standard careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: VRH (Virtual Reality Hypnosis); Behavioral: Standard care |
| Standard treatment | Placebo comparator | Patients in the control group received only standard care. Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T1(before intervention) and T3 (directly after intervention)
Secondary outcomes (4)
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
Measured: T4 (30 min after intervention)
Maternal heart rate
Measured heart rate during and after intervention as an absolute value.
Measured: 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))
Measured: 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
Measured: T6 (day 1 postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Mar 2021
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective interventional Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Saint-Jean, Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Arnaud Bosteels, Clinique Saint-Jean, Bruxelles
- Investigators
- Louise Piccart, Dr., Study chair, Resident Anesthesiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167383
- Sponsor's protocol ID
- VRH4L
- Acronym
- VRH4L
- Status last verified
- Jan 2022
- First submitted
- 6 Nov 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication of abstract (Poster on the ESA 2021) and Study Report (Paper in the Acta Belgica, end of 2021)
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Monocentric Study Evaluating the Impact of Virtual Reality Hypnosis During Labor
- ClinicalTrials.gov ID
- NCT05167383
- Acronym / sponsor ID
- VRH4L / VRH4L
- Conditions
- Labor Pain, Virtual Reality, Hypnosis
- Keywords
- non-pharmacological analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Clinique Saint-Jean, BruxellesUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Prospective interventional Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention VR group | Active comparator | Device: VRH (Virtual Reality Hypnosis), Behavioral: Standard care. 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. |
| Standard treatment | Placebo comparator | Behavioral: Standard carePatients in the control group received only standard care. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRH (Virtual Reality Hypnosis)Hypnosis is delivered as a standardized therapeutic intervention through virtual reality, using a digital sedation software (AQUA ®, Onfomfort SA). | Device | Intervention VR group |
| Standard careThe 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. | Behavioural | Intervention VR group, Standard treatment |
Primary outcome
Post interventional pain scores
Time frame: T1(before intervention) and T3 (directly after intervention)
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.
4 secondary outcomes
Pain 30 minutes after intervention
Time frame: T4 (30 min after intervention)
Maternal heart rate
Time frame: T1(before intervention) , T2 (During intervention), T3 (directly after intervention) and T4 (30 min after intervention)
Nausea
Time frame: T1(before intervention) , T3 (directly after intervention) and T4 (30 min after intervention)
Satisfaction of the mother
Time frame: T6 (day 1 postpartum)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Individual participant dataSharing planned: Yes. Publication of abstract (Poster on the ESA 2021) and Study Report (Paper in the Acta Belgica, end of 2021)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Piccart, Dr. study chair
Resident Anesthesiologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VRH (Virtual Reality Hypnosis) in people with Labor Pain and Virtual Reality, run by Clinique Saint-Jean, Bruxelles at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post interventional pain scores (time frame: T1(before intervention) and T3 (directly after intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.