Labor PainNCT03437031

Virtual Reality in Labor and Delivery for Reduction in Pain

A study testing Virtual Reality device in people with Labor Pain and Virtual Reality, run by Cedars-Sinai Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to identify whether use of virtual reality devices can improve the pain management of women in labor and delivery. The investigators will perform a randomized controlled trial of patients in labor at Cedars-Sinai Medical Center. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Labor Pain, Virtual Reality, Alternative Medicine
What is being tested?: Virtual Reality device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2018to 19 Feb 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Female
>18 years old
Pregnant with term gestation
Nullipara
Pain due to contractions rated from 4-7
Contractions at least every 5 minutes x 30 minutes preceding
Pain scores obtained at least every 60 minutes

Who cannot join

Parous
Use of intravenous medications for pain relief prior to the intervention
Use of an epidural
Preterm gestation
Pain not due to contractions
Pain score of 3 or below or 8 or above

Trial locations and contacts

1 site in 1 country.

United States1 site

Cedars-Sinai Medical Center
Los Angeles, California, 90048

Other trials in United States

About this study

Read the detailed description

The purpose of this study is to identify whether use of virtual reality devices can improve the pain management of women in labor and delivery. The investigators hypothesize that use of virtual reality devices will result in a reduction in pain medication use, in epidural use, and prolong the duration of time prior to the patient receiving an epidural.

The study will be conducted as two parallel randomized controlled trials: one for latent labor patients and one for patients in active labor (defined by whether they are < 6 cm or > 6 cm). Within each phase of labor, there will be 20 in the Virtual Reality arm and 20 in the Control arm for a total of 80 patients.

Conditions: Labor Pain, Virtual Reality, Alternative Medicine
Being tested: Virtual Reality device
Keywords: Labor Pain, Virtual Reality, Alternative Medicine
Medical subject headings: Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual Reality deviceDevice
For those patients randomized to VR, the study staff member will explain the use of the Samsung VR goggle set, and thereafter will allow the patient to use the device freely for up to 30 minutes. Intervals of 2-5 minutes is suggested for first-time use, and patients will be to allowed to discontinue it at any time as long as they are not experiencing any discomfort or side effects (dizziness, motion sickness, etc.). The study staff member will be present at all times, and will work with hospital staff as necessary to ensure the patient is receiving appropriate clinical care throughout the duration of the intervention.

Study groups in NCT03437031
Study group	Role	What they receive
Latent-Control	No intervention	Patients in the latent phase of labor who will receive no intervention.
Latent-Virtual Reality (VR)	Experimental	Patients in the latent phase of labor who will receive the Virtual Reality (VR) intervention. Receives: Device: Virtual Reality device

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduction in Pain
Difference in pain scores pre-post intervention compared to control. The investigators will use the Visual Analog Scale (VAS) for Pain. The minimum pain is 1; the maximum is 10. Higher values represent more pain.
Measured: 4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention

Secondary outcomes (4)

Number of Participants With a Need for Intravenous Pain Medication
IV pain medication during the intervention (yes/no)
Measured: The total duration of the intervention (30 minutes)
Need for Epidural During the Intervention
Number of participants with need for an epidural during the intervention
Measured: The total duration of the intervention (30 minutes)
Childbirth Self-Efficacy Inventory
The Childbirth Self-Efficacy Inventory (CSEI) is a measure of how well a patient anticipates being able to perform certain tasks in labor such as relaxing their body, keeping calm, or not thinking about the pain. The investigators will ask to what extend they feel virtual reality would be able to influence their ability to do these things. A fifteen-question scale reflecting degree of control where 1 is least control and 5 is most control per item. Minimum score 15 reflecting least total control; maximum score 75 reflecting maximal control.
Measured: 30 minutes
Number of Participants With a Need for Epidural During the Labor
Epidural use during labor (yes/no)
Measured: The total duration of the patient's labor (average 24 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201819 Feb 2019

First posted19 Feb 2018
Study start1 Mar 2018
Primary completion19 Feb 2019
Study completion19 Feb 2019

Why it stopped: Problems with recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Labor PainStudies of the same condition, open and under way.
More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
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: Parallel randomized controlled trials
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03437031
Sponsor's protocol ID: Pro00050082
Status last verified: Oct 2021
First submitted: 16 Jan 2018
Last updated: 26 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.
PubMed 28356241
Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BM. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801.
PubMed 27349654

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Labor Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Virtual Reality in Labor and Delivery for Reduction in Pain
ClinicalTrials.gov ID: NCT03437031
Acronym / sponsor ID: Pro00050082
Conditions: Labor Pain, Virtual Reality, Alternative Medicine
Keywords: Labor Pain, Virtual Reality, Alternative Medicine
Study type: Interventional
Recruitment status: TerminatedReason stopped: Problems with recruitment
Enrolment: 40 participants (actual)
Lead sponsor: Cedars-Sinai Medical CenterUniversity, hospital or other
Study start: 1 Mar 2018 (actual)
Primary completion: 19 Feb 2019 (actual)
Study completion: 19 Feb 2019 (actual)
First posted: 19 Feb 2018 (actual)
Results: Posted 26 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Parallel randomized controlled trials

Arm	Type	Receives
Latent-Control	No intervention	–Patients in the latent phase of labor who will receive no intervention.
Latent-Virtual Reality (VR)	Experimental	Device: Virtual Reality devicePatients in the latent phase of labor who will receive the Virtual Reality (VR) intervention.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Female
>18 years old
Pregnant with term gestation
Nullipara
Pain due to contractions rated from 4-7

Key exclusion criteria (6 listed)

Parous
Use of intravenous medications for pain relief prior to the intervention
Use of an epidural
Preterm gestation
Pain not due to contractions

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
Virtual Reality deviceFor those patients randomized to VR, the study staff member will explain the use of the Samsung VR goggle set, and thereafter will allow the patient to use the device freely for up to 30 minutes. Intervals of 2-5 minutes is suggested for first-time use, and patients will be to allowed to discontinue it at any time as long as they are not experiencing any discomfort or side effects (dizziness, motion sickness, etc.). The study staff member will be present at all times, and will work with hospital staff as necessary to ensure the patient is receiving appropriate clinical care throughout the duration of the intervention.	Device	Latent-Virtual Reality (VR)

Primary outcome

Reduction in Pain
Time frame: 4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention
Difference in pain scores pre-post intervention compared to control. The investigators will use the Visual Analog Scale (VAS) for Pain. The minimum pain is 1; the maximum is 10. Higher values represent more pain.

4 secondary outcomes

Number of Participants With a Need for Intravenous Pain Medication
Time frame: The total duration of the intervention (30 minutes)
Need for Epidural During the Intervention
Time frame: The total duration of the intervention (30 minutes)
Childbirth Self-Efficacy Inventory
Time frame: 30 minutes
Number of Participants With a Need for Epidural During the Labor
Time frame: The total duration of the patient's labor (average 24 hours)

Results and safety

Results posted to the registry on 26 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Latent-Control	19	19
Latent-VR	21	21

Primary outcome: Reduction in Pain

Time frame: 4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention. Mean (Full Range). Unit: score on a scale

Measure	Latent-Control n = 19	Latent-VR n = 21
Average Pain Score in 4 hours PRIOR to Intervention	3.39 (0 to 7)	4.52 (1.3 to 7)
Pre-Intervention Pain score	5.05 (4 to 7)	6 (4 to 7)
Post-Intervention Pain score	5.63 (4 to 10)	5.48 (0 to 8)
Average Pain Score in 2 hours AFTER Intervention	5.44 (4 to 7.5)	5 (0 to 8)
Average Pain Score in 4 hours AFTER Intervention	6.2 (4.3 to 8.7)	5.48 (1 to 8.5)
Average Pain Score in 24 hours AFTER Intervention	–	3.36 (2.75 to 4)

Population analysed: Average Pain Score in 2 hours AFTER Intervention data available only for 9/19 Latent-Control participants and 14/21 Latent-VR participants Average Pain Score in 4 hours AFTER Intervention data available only for 7/19 Latent-Control participants and 12/21 Latent-VR participants Average Pain Score in 24 hours AFTER Intervention data available only for 0/19 Latent-Control participants and 2/21 Latent-VR participants

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Latent-Control	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Latent-VR	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Active-Control	0 of 0	0 of 0	0
Active-VR	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28356241Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.
Background: PubMed 27349654Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BM. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality device in people with Labor Pain and Virtual Reality, run by Cedars-Sinai Medical Center at 1 site in United States.

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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 26 Nov 2021. 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 United States. 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. 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?

Yes. Results are posted in the registry (first posted 26 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Reduction in Pain (time frame: 4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03437031, which also lists 2 linked publications.

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 26 Nov 2021.