Virtual Reality in Labor and Delivery for Reduction in Pain

• Sponsor: Cedars-Sinai Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03437031
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.7
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain; Virtual Reality; Alternative Medicine	Device: Virtual Reality device	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel randomized controlled trialsParallel randomized controlled trials
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Virtual Reality in Labor and Delivery for Reduction in Pain
• Actual Study Start Date: Mar 1, 2018
• Actual Primary Completion Date: Feb 19, 2019
• Actual Study Completion Date: Feb 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Latent-Control Patients in the latent phase of labor who will receive no intervention.
Experimental: Latent-Virtual Reality (VR) Patients in the latent phase of labor who will receive the Virtual Reality (VR) intervention.	Device: Virtual Reality device; 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.

Outcome Measures

Primary Outcome Measures

1. Reduction in Pain [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.

Secondary Outcome Measures

1. Number of Participants With a Need for Intravenous Pain Medication [The total duration of the intervention (30 minutes)]

   IV pain medication during the intervention (yes/no)

2. Need for Epidural During the Intervention [The total duration of the intervention (30 minutes)]

   Number of participants with need for an epidural during the intervention

3. Childbirth Self-Efficacy Inventory [30 minutes]

   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.

4. Number of Participants With a Need for Epidural During the Labor [The total duration of the patient's labor (average 24 hours)]

   Epidural use during labor (yes/no)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Female

2. 18 years old

3. Pregnant with term gestation

4. Nullipara

5. Pain due to contractions rated from 4-7

6. Contractions at least every 5 minutes x 30 minutes preceding

7. Pain scores obtained at least every 60 minutes

Exclusion Criteria:

1. Parous

2. Use of intravenous medications for pain relief prior to the intervention

3. Use of an epidural

4. Preterm gestation

5. Pain not due to contractions

6. Pain score of 3 or below or 8 or above

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

• Cedars-Sinai Medical Center

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 25, 2021

More Information

Publications

• 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.
• 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.

• Responsible Party: Kimberly Gregory, Professor, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT03437031
• Other Study ID Numbers: Pro00050082
• First Posted: Feb 19, 2018
• Last Update Posted: Nov 26, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Kimberly Gregory, Professor, Cedars-Sinai Medical Center: Labor Pain; Virtual Reality; Alternative Medicine
• Additional relevant MeSH terms: Labor Pain

Study Results

Participant Flow

Recruitment Details	Enrollment began in March 2018 and completed in February 2019. Patients were recruited in the labor and delivery inpatient setting.
Pre-assignment Detail	No events occurred between recruitment, enrollment, and randomization/assignment to a study arm.

Arm/Group Title	Latent-Control	Latent-VR
Arm/Group Description	Patients in the latent phase of labor who will receive no intervention.	Patients in the latent phase of labor who will receive the VR intervention. Virtual Reality device: 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.
Period Title: Overall Study
STARTED	19	21
COMPLETED	19	21
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Latent-Control	Latent-VR	Total
Arm/Group Description	Patients in the latent phase of labor who will receive no intervention.	Patients in the latent phase of labor who will receive the VR intervention. Virtual Reality device: 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.	Total of all reporting groups
Overall Participants	19	21	40
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	32.47	31.57	32
Sex: Female, Male (Count of Participants)
Female	19 100%	21 100%	40 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 5.3%	6 28.6%	7 17.5%
Not Hispanic or Latino	18 94.7%	15 71.4%	33 82.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 4.8%	1 2.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 10.5%	2 9.5%	4 10%
White	17 89.5%	14 66.7%	31 77.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	4 19%	4 10%
Gravidity (pregnancies) [Mean (Full Range) ]
Mean (Full Range) [pregnancies]	1.16	1.29	1.23
Parity (pregnancies) [Mean (Full Range) ]
Mean (Full Range) [pregnancies]	0	0	0
Insurance (Count of Participants)
HMO / Managed Care	0 0%	4 19%	4 10%
Medicaid	1 5.3%	2 9.5%	3 7.5%
Private	18 94.7%	14 66.7%	32 80%
Self-pay / None	0 0%	1 4.8%	1 2.5%
BMI (kg/m^2) [Mean (Full Range) ]
Mean (Full Range) [kg/m^2]	27.29	30.11	28.77

Outcome Measures

1. Primary Outcome

Title	Reduction in Pain
Description	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.
Time Frame	4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Latent-Control	Latent-VR
Arm/Group Description	Patients in the latent phase of labor who will receive no intervention.	Patients in the latent phase of labor who will receive the VR intervention. Virtual Reality device: 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.
Measure Participants	19	21
Average Pain Score in 4 hours PRIOR to Intervention	3.39	4.52
Pre-Intervention Pain score	5.05	6
Post-Intervention Pain score	5.63	5.48
Average Pain Score in 2 hours AFTER Intervention	5.44	5
Average Pain Score in 4 hours AFTER Intervention	6.2	5.48
Average Pain Score in 24 hours AFTER Intervention	3.36

2. Secondary Outcome

Title	Number of Participants With a Need for Intravenous Pain Medication
Description	IV pain medication during the intervention (yes/no)
Time Frame	The total duration of the intervention (30 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Latent-Control	Latent-VR
Arm/Group Description	Patients in the latent phase of labor who will receive no intervention.	Patients in the latent phase of labor who will receive the VR intervention. Virtual Reality device: 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.
Measure Participants	19	21
Count of Participants [Participants]	0 0%	0 0%

3. Secondary Outcome

Title	Need for Epidural During the Intervention
Description	Number of participants with need for an epidural during the intervention
Time Frame	The total duration of the intervention (30 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Latent-Control	Latent-VR
Arm/Group Description	Patients in the latent phase of labor who will receive no intervention.	Patients in the latent phase of labor who will receive the VR intervention. Virtual Reality device: 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.
Measure Participants	19	21
Count of Participants [Participants]	0 0%	0 0%

4. Secondary Outcome

Title	Childbirth Self-Efficacy Inventory
Description	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.
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Latent-Control	Latent-VR
Arm/Group Description	Patients in the latent phase of labor who will receive no intervention.	Patients in the latent phase of labor who will receive the VR intervention. Virtual Reality device: 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.
Measure Participants	19	21
Mean (Standard Deviation) [score on a scale]	54.8 (11.2)	52.6 (11.8)

5. Secondary Outcome

Title	Number of Participants With a Need for Epidural During the Labor
Description	Epidural use during labor (yes/no)
Time Frame	The total duration of the patient's labor (average 24 hours)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Latent-Control	Latent-VR
Arm/Group Description	Patients in the latent phase of labor who will receive no intervention.	Patients in the latent phase of labor who will receive the VR intervention. Virtual Reality device: 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.
Measure Participants	19	21
Count of Participants [Participants]	17 89.5%	18 85.7%

Adverse Events

Time Frame	6 weeks
Adverse Event Reporting Description	0 participants in Active-Control group and 0 participants Active-VR group. Participants were not recruited into these two groups.
Arm/Group Title	Latent-Control		Latent-VR		Active-Control		Active-VR
Arm/Group Description	Patients in the latent phase of labor who will receive no intervention.		Patients in the latent phase of labor who will receive the VR intervention. Virtual Reality device: 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.		Patients in the active phase of labor who will receive no intervention.		Patients in the active phase of labor who will receive the VR intervention. Virtual Reality device: 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.
All Cause Mortality
	Latent-Control		Latent-VR		Active-Control		Active-VR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/21 (0%)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Latent-Control		Latent-VR		Active-Control		Active-VR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/21 (0%)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Latent-Control		Latent-VR		Active-Control		Active-VR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/21 (0%)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.