Alternative Medicine, Labor Pain, Virtual Reality
Conditions
Keywords
Labor Pain, Virtual Reality, Alternative Medicine
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.
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.
Interventions
DEVICEVirtual 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.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel randomized controlled trials
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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. |
| 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) |
Countries
United States
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 details
No events occurred between recruitment, enrollment, and randomization/assignment to a study arm.
Participants by arm
| Arm | Count |
|---|---|
| Latent-Control Patients in the latent phase of labor who will receive no intervention. | 19 |
| Latent-VR 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. | 21 |
| Total | 40 |
Baseline characteristics
| Characteristic | Latent-Control | Latent-VR | Total |
|---|---|---|---|
| Age, Continuous | 32.47 years | 31.57 years | 32 years |
| BMI | 27.29 kg/m^2 | 30.11 kg/m^2 | 28.77 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 6 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 15 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gravidity | 1.16 pregnancies | 1.29 pregnancies | 1.23 pregnancies |
| Insurance HMO / Managed Care | 0 Participants | 4 Participants | 4 Participants |
| Insurance Medicaid | 1 Participants | 2 Participants | 3 Participants |
| Insurance Private | 18 Participants | 14 Participants | 32 Participants |
| Insurance Self-pay / None | 0 Participants | 1 Participants | 1 Participants |
| Parity | 0 pregnancies | 0 pregnancies | 0 pregnancies |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 17 Participants | 14 Participants | 31 Participants |
| Sex: Female, Male Female | 19 Participants | 21 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 21 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 19 | 0 / 21 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Latent-Control | Reduction in Pain | Average Pain Score in 2 hours AFTER Intervention | 5.44 score on a scale |
| Latent-Control | Reduction in Pain | Post-Intervention Pain score | 5.63 score on a scale |
| Latent-Control | Reduction in Pain | Average Pain Score in 4 hours AFTER Intervention | 6.2 score on a scale |
| Latent-Control | Reduction in Pain | Pre-Intervention Pain score | 5.05 score on a scale |
| Latent-Control | Reduction in Pain | Average Pain Score in 4 hours PRIOR to Intervention | 3.39 score on a scale |
| Latent-VR | Reduction in Pain | Average Pain Score in 4 hours AFTER Intervention | 5.48 score on a scale |
| Latent-VR | Reduction in Pain | Average Pain Score in 24 hours AFTER Intervention | 3.36 score on a scale |
| Latent-VR | Reduction in Pain | Average Pain Score in 4 hours PRIOR to Intervention | 4.52 score on a scale |
| Latent-VR | Reduction in Pain | Pre-Intervention Pain score | 6 score on a scale |
| Latent-VR | Reduction in Pain | Post-Intervention Pain score | 5.48 score on a scale |
| Latent-VR | Reduction in Pain | Average Pain Score in 2 hours AFTER Intervention | 5 score on a scale |
Secondary
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.
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Latent-Control | Childbirth Self-Efficacy Inventory | 54.8 score on a scale | Standard Deviation 11.2 |
| Latent-VR | Childbirth Self-Efficacy Inventory | 52.6 score on a scale | Standard Deviation 11.8 |
Secondary
Need for Epidural During the Intervention
Number of participants with need for an epidural during the intervention
Time frame: The total duration of the intervention (30 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Latent-Control | Need for Epidural During the Intervention | 0 Participants |
| Latent-VR | Need for Epidural During the Intervention | 0 Participants |
Secondary
Number of Participants With a Need for Epidural During the Labor
Epidural use during labor (yes/no)
Time frame: The total duration of the patient's labor (average 24 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Latent-Control | Number of Participants With a Need for Epidural During the Labor | 17 Participants |
| Latent-VR | Number of Participants With a Need for Epidural During the Labor | 18 Participants |
Secondary
Number of Participants With a Need for Intravenous Pain Medication
IV pain medication during the intervention (yes/no)
Time frame: The total duration of the intervention (30 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Latent-Control | Number of Participants With a Need for Intravenous Pain Medication | 0 Participants |
| Latent-VR | Number of Participants With a Need for Intravenous Pain Medication | 0 Participants |