Lower Back Pain, Lumbar Radiculopathy
Conditions
Keywords
epidural steroid injection, virtual reality, distraction, sedation, lumbar radiculopathy
Brief summary
This study examines the impact of virtual reality compared to sedation (midazolam and/or fentanyl) and no intervention on pain experienced from an epidural steroid injection (ESI). The intervention group (who receive virtual reality as a distraction modality) is compared to a sedation group and a control group.
Detailed description
All patients enrolled in the study will already be undergoing lumbar epidural steroid injections for lumbar radicular pain as part of their clinical care. The epidural approach will either be transforaminal or interlaminar depending on clinical judgment (i.e. transforaminal ESI for unilateral pain, interlaminar ESI for bilateral pain). The study will consist of 3 groups: virtual reality, sedation, and a control group which receives no intervention (i.e. standard of care). The virtual reality group will receive virtual reality via a headset containing a menu of 6 programs that the subject can choose; the sedation group will receive from 1-5 mg of midazolam and up to 150 mcg of fentanyl as clinically indicated, and the control group will not receive an intervention (standard of care). All subjects will also receive 1% lidocaine local anesthetic through a 25-gauge needle for superficial anesthesia, which is standard of care. Subjects will be randomized to each of these groups, with sub-allocation being done stratified by the type of ESI (transforaminal vs. interlaminar). A secondary pilot study will evaluate whether a processed electroencephalogram (pEEG) and continuous colored density spectral array monitored via a four-channel Masimo SEDLine frontal EEG sensor can serve as a biomarker for painful stimulation and the effectiveness of distraction and sedation to reduce acute pain.
Interventions
DEVICEVirtual reality
Subjects in the virtual reality group will be offered a variety of immersive environments to choose from (mountains, beach, rainforest and temperate forest) in addition to local anesthetic.
Sedation will be administered using low-dose midazolam and/ or fentanyl. We will use a wide range of dosing (1-5 mg for midazolam, up to 150 mcg for fentanyl) to maximize generalizability and account for widespread variability in clinical circumstances, medical practice and patient response (personalized medicine). Sedation will be titrated to effect by a board-certified or eligible anesthesiologist so that patients remain responsive to verbal stimuli.
OTHERStandard care
Patients will receive superficial local anesthetic with 1% lidocaine. Local anesthetic will be administered by the physician performing the procedure titrated to patient comfort.
Sponsors
United States Department of Defense
The Geneva Foundation
Walter Reed National Military Medical Center
United States Naval Medical Center, San Diego
Brigham and Women's Hospital
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor will be unaware of treatment allocation but the patient and provider cannot be.
Intervention model description
Parallel study comparing virtual reality to sedation to standard care (no sedation or virtual reality) for procedure-related pain in patients undergoing lumbar epidural steroid injections.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Males and females; ages 18-90 years * Lumbosacral radicular pain with a baseline average of leg pain score of \> 4/10, MRI findings (if available) consistent with symptoms, duration of pain \> 6 weeks, and no previous lumbar spine surgery. * Documented diagnosis of radicular pain caused by herniated disc, central stenosis, foraminal stenosis, degenerative disk disease * Willingness to adhere to undergo ESI with either sedation (midazolam and or fentanyl) or with virtual reality * Able to appear for a follow up visit between 24-40 days following the intervention
Exclusion criteria
* MRI findings discordant with symptoms (absence of herniated disc, spinal stenosis or severe disc degeneration without nerve root impingement (e.g. annular tears) that could explain symptoms) * Previous lumbosacral spine surgery at the area affected * Prior ESI within the past 6 months * Allergy to contrast dye * Poorly controlled psychiatric conditions that could affect outcomes (e.g. active substance abuse) or impose a barrier to participation (e.g. anxiety disorder requiring procedural sedation) * Morbid obesity (BMI \>40)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score During Procedure | Immediately after procedure | 0-10 verbal rating scale (higher scores indicate greater pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subcutaneous Skin Wheal Pain Score | Immediately after skin wheal | 0-10 verbal rating scale (higher scores indicate greater pain) |
| Procedure Satisfaction | In postanesthetic care unit (within 1 hour) | This outcome was measured using a standalone question using the 1-5 Likert scale (1= very unsatisfied, 3= neither satisfied nor dissatisfied, 5= very satisfied). A mean of the participant selection is reported. |
| Ability to Communicate | In postanesthetic care unit (within 1 hour) | This outcome was measured using a standalone question using the 1-5 Likert scale (1= complete inability to communicate, 2= markedly decreased ability to communicate, 3= slightly decreased ability to communicate, 4= no change in ability to communicate, 5= improved ability to communicate). A mean of the participant selection is reported. |
| Procedure-related Anxiety | In postanesthetic care unit (within 1 hour) | This outcome was measured using a standalone question using the 1-5 Likert scale (1=extreme anxiety, 2=high anxiety, 3=average or expected anxiety, 4=minimal or mild anxiety, 5=no anxiety. A mean of the participant selection is reported. |
| Time to Discharge From Postanesthetic Care Unit | At discharge from postanesthetic care unit assessed up to 6 hours | Time to discharge from postanesthetic care unit, in minutes |
| Hospital Anxiety and Depression Scale (HADS) Scores for Anxiety and Depressions | 4 weeks | The Hospital anxiety and depression scale (HADS) is an instrument used to measure depression and anxiety. Anxiety and depression are scored separately, each on a subscale. The score on each subscale ranges from 0 to 21 score on a scale. A score of 0 indicates the absence of depression or anxiety. A score of 21 indicated severe depression or anxiety. The subscales are not combined for a total score. Anxiety score is reported. |
| Participants With Positive Categorical Outcome | 4 weeks | This outcome measure is either positive or negative. A positive outcome is measured by participants with a 2-point or greater reduction in average leg pain score coupled with participants with a score of 5 or greater score on the Patient Global Impression of Change (PGIC), or negative is measure by a 1 or no point reduction in the average leg pain score couple with a 4 or less score on the Patient Global Impression of Change (PGIC). The average leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain). The Patient global impression of change on 7-point Likert scale (from 1= no change, 3= a little better 5= moderately better, a slight but noticeable change, to 7=a great deal better, a considerable improvement that has made all the difference). Participants with positive outcome are reported. |
| Average Leg Pain Score | 4 weeks | Average leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain) |
| Amount of Local Anesthetic Required | At the start of the procedure | Volume of 1% lidocaine used to complete the skin wheel prior to the procedure. |
| Average Back Pain Score | 4 weeks | Average back pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain) |
| Worst Back Pain Score | 4 weeks | Worst back pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain) |
| Patient Global Impression of Change (PGIC) | 4 weeks | Patient global impression of change on 7-point Likert scale (from 1= no change, 3= a little better 5= moderately better, a slight but noticeable change, to 7=a great deal better, a considerable improvement that has made all the difference) |
| Number of Participants With Analgesic Reduction | 4 weeks | Categorical reduction in analgesic usage (cessation of non-opioid analgesic and/ or \> 20% reduction in opioid use) |
| Oswestry Disability Index (ODI) Score | 4 weeks | Functional measurement of back and leg pain disability on 0-100% scale (higher levels indicate greater disability) |
| Number of Participants With Complications | 4 weeks | Number of Participants With Complications related to the procedure, sedation or use of virtual reality |
| Percentage Change of the Spectral Edge Frequency (SEF) | During the procedure for up to 20 minutes | Frontal EEG sensor will be placed with electrode positions corresponding to Fp1, Fp2, F7, and F8 in the international 10-20 system. The spectral edge frequency (SEF) on the Sedline monitor ranges in frequency from 0 to 30 Hz. |
| Hospital Anxiety and Depression Scale (HADS) Scores for Depression and Anxiety | 4 weeks | The Hospital anxiety and depression scale (HADS) is an instrument used to measure depression and anxiety. Anxiety and depression are scored separately, each on a subscale. The score on each subscale ranges from 0 to 21 score on a scale. A score of 0 indicates the absence of depression or anxiety. A score of 21 indicated severe depression or anxiety. The subscales are not combined for a total score. Depression score is reported. |
| Worst Leg Pain Score | 4 weeks | Worst leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Virtual Reality (VR) Subjects in the VR group will be fitted with an HTC headset and headphones with disposable ear covers. The subjects will choose from a menu of 6 different programs. The subjects will also receive 1% superficial anesthesia.
Virtual reality: Subjects in the virtual reality group will be offered a variety of immersive environments to choose from (mountains, beach, rainforest and temperate forest) in addition to local anesthetic. | 48 |
| Sedation Conscious sedation will be accomplished by the use of midazolam and/ or fentanyl. The investigators will use a wide range of dosing (1-5 mg for midazolam, up to 150 mcg for fentanyl) to maximize generalizability and account for widespread variability in clinical circumstances, medical practice and patient response (personalized medicine). All medications will be titrated to conscious sedation by a board-certified anesthesiologist. Subjects will also receive 1% superficial anesthesia.
Intravenous sedation: Sedation will be administered using low-dose midazolam and/ or fentanyl. The investigators will use a wide range of dosing (1-5 mg for midazolam, up to 150 mcg for fentanyl) to maximize generalizability and account for widespread variability in clinical circumstances, medical practice and patient response (personalized medicine). Sedation will be titrated to effect by a board-certified or eligible anesthesiologist so that patients remain responsive to verbal stimuli. | 50 |
| Standard Care Patients in this arm will be administered only 1% lidocaine as superficial anesthesia, similar to the other 2 arms.
Standard care: Patients will receive superficial local anesthetic with 1% lidocaine. Local anesthetic will be administered by the physician performing the procedure titrated to patient comfort. | 48 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 | 3 |
Baseline characteristics
| Characteristic | Virtual Reality (VR) | Total | Standard Care | Sedation |
|---|---|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 13 | 57 years STANDARD_DEVIATION 14 | 56 years STANDARD_DEVIATION 16 | 58 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 144 Participants | 47 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 26 Participants | 73 Participants | 25 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 39 Participants | 13 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 7 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 12 Participants | 27 Participants | 8 Participants | 7 Participants |
| Region of Enrollment Thailand | 21 Participants | 59 Participants | 19 Participants | 19 Participants |
| Region of Enrollment United States | 27 Participants | 87 Participants | 29 Participants | 31 Participants |
| Sex: Female, Male Female | 31 Participants | 95 Participants | 27 Participants | 37 Participants |
| Sex: Female, Male Male | 17 Participants | 51 Participants | 21 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 50 | 0 / 48 |
| other Total, other adverse events | 5 / 48 | 10 / 50 | 4 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 50 | 0 / 48 |
Outcome results
Primary
Pain Score During Procedure
0-10 verbal rating scale (higher scores indicate greater pain)
Time frame: Immediately after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) | Pain Score During Procedure | 3.7 score on a scale | Standard Deviation 2.5 |
| Sedation | Pain Score During Procedure | 3.2 score on a scale | Standard Deviation 3 |
| Standard Care | Pain Score During Procedure | 5.2 score on a scale | Standard Deviation 3.1 |
Secondary
Ability to Communicate
This outcome was measured using a standalone question using the 1-5 Likert scale (1= complete inability to communicate, 2= markedly decreased ability to communicate, 3= slightly decreased ability to communicate, 4= no change in ability to communicate, 5= improved ability to communicate). A mean of the participant selection is reported.
Time frame: In postanesthetic care unit (within 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) | Ability to Communicate | 4.1 score on a scale | Standard Deviation 0.5 |
| Sedation | Ability to Communicate | 3.7 score on a scale | Standard Deviation 0.9 |
| Standard Care | Ability to Communicate | 4.0 score on a scale | Standard Deviation 0.4 |
Secondary
Amount of Local Anesthetic Required
Volume of 1% lidocaine used to complete the skin wheel prior to the procedure.
Time frame: At the start of the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) | Amount of Local Anesthetic Required | 5.6 milliliters | Standard Deviation 2.5 |
| Sedation | Amount of Local Anesthetic Required | 5.4 milliliters | Standard Deviation 2.6 |
| Standard Care | Amount of Local Anesthetic Required | 6.3 milliliters | Standard Deviation 2.9 |
Secondary
Average Back Pain Score
Average back pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)
Time frame: 4 weeks
Population: Participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) | Average Back Pain Score | 3.1 score on a scale | Standard Deviation 2.3 |
| Sedation | Average Back Pain Score | 3.5 score on a scale | Standard Deviation 2.6 |
| Standard Care | Average Back Pain Score | 3.6 score on a scale | Standard Deviation 2.7 |
Secondary
Average Leg Pain Score
Average leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)
Time frame: 4 weeks
Population: Participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) | Average Leg Pain Score | 3.0 score on a scale | Standard Deviation 2.4 |
| Sedation | Average Leg Pain Score | 3.1 score on a scale | Standard Deviation 4.8 |
| Standard Care | Average Leg Pain Score | 3.8 score on a scale | Standard Deviation 2.7 |
Secondary
Hospital Anxiety and Depression Scale (HADS) Scores for Anxiety and Depressions
The Hospital anxiety and depression scale (HADS) is an instrument used to measure depression and anxiety. Anxiety and depression are scored separately, each on a subscale. The score on each subscale ranges from 0 to 21 score on a scale. A score of 0 indicates the absence of depression or anxiety. A score of 21 indicated severe depression or anxiety. The subscales are not combined for a total score. Anxiety score is reported.
Time frame: 4 weeks
Population: Participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) | Hospital Anxiety and Depression Scale (HADS) Scores for Anxiety and Depressions | 4.9 score on a scale | Standard Deviation 4 |
| Sedation | Hospital Anxiety and Depression Scale (HADS) Scores for Anxiety and Depressions | 5.1 score on a scale | Standard Deviation 4.5 |
| Standard Care | Hospital Anxiety and Depression Scale (HADS) Scores for Anxiety and Depressions | 4.3 score on a scale | Standard Deviation 3 |
Secondary
Hospital Anxiety and Depression Scale (HADS) Scores for Depression and Anxiety
The Hospital anxiety and depression scale (HADS) is an instrument used to measure depression and anxiety. Anxiety and depression are scored separately, each on a subscale. The score on each subscale ranges from 0 to 21 score on a scale. A score of 0 indicates the absence of depression or anxiety. A score of 21 indicated severe depression or anxiety. The subscales are not combined for a total score. Depression score is reported.
Time frame: 4 weeks
Population: Participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) | Hospital Anxiety and Depression Scale (HADS) Scores for Depression and Anxiety | 4.0 score on a scale | Standard Deviation 3.9 |
| Sedation | Hospital Anxiety and Depression Scale (HADS) Scores for Depression and Anxiety | 4.5 score on a scale | Standard Deviation 3.9 |
| Standard Care | Hospital Anxiety and Depression Scale (HADS) Scores for Depression and Anxiety | 3.8 score on a scale | Standard Deviation 3.5 |
Secondary
Number of Participants With Analgesic Reduction
Categorical reduction in analgesic usage (cessation of non-opioid analgesic and/ or \> 20% reduction in opioid use)
Time frame: 4 weeks
Population: Five participants were lost to follow-up and did not have 4 weeks outcomes measured. Eleven participants did not have data recorded for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual Reality (VR) | Number of Participants With Analgesic Reduction | 16 Participants |
| Sedation | Number of Participants With Analgesic Reduction | 19 Participants |
| Standard Care | Number of Participants With Analgesic Reduction | 7 Participants |
Secondary
Number of Participants With Complications
Number of Participants With Complications related to the procedure, sedation or use of virtual reality
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual Reality (VR) | Number of Participants With Complications | 5 Participants |
| Sedation | Number of Participants With Complications | 10 Participants |
| Standard Care | Number of Participants With Complications | 4 Participants |
Secondary
Oswestry Disability Index (ODI) Score
Functional measurement of back and leg pain disability on 0-100% scale (higher levels indicate greater disability)
Time frame: 4 weeks
Population: Participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) | Oswestry Disability Index (ODI) Score | 32 score on a scale | Standard Deviation 17 |
| Sedation | Oswestry Disability Index (ODI) Score | 36 score on a scale | Standard Deviation 17 |
| Standard Care | Oswestry Disability Index (ODI) Score | 34 score on a scale | Standard Deviation 15 |
Secondary
Participants With Positive Categorical Outcome
This outcome measure is either positive or negative. A positive outcome is measured by participants with a 2-point or greater reduction in average leg pain score coupled with participants with a score of 5 or greater score on the Patient Global Impression of Change (PGIC), or negative is measure by a 1 or no point reduction in the average leg pain score couple with a 4 or less score on the Patient Global Impression of Change (PGIC). The average leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain). The Patient global impression of change on 7-point Likert scale (from 1= no change, 3= a little better 5= moderately better, a slight but noticeable change, to 7=a great deal better, a considerable improvement that has made all the difference). Participants with positive outcome are reported.
Time frame: 4 weeks
Population: Participants who completed the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual Reality (VR) | Participants With Positive Categorical Outcome | 25 Participants |
| Sedation | Participants With Positive Categorical Outcome | 25 Participants |
| Standard Care | Participants With Positive Categorical Outcome | 24 Participants |
Secondary
Patient Global Impression of Change (PGIC)
Patient global impression of change on 7-point Likert scale (from 1= no change, 3= a little better 5= moderately better, a slight but noticeable change, to 7=a great deal better, a considerable improvement that has made all the difference)
Time frame: 4 weeks
Population: Participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) | Patient Global Impression of Change (PGIC) | 4.7 score on a scale | Standard Deviation 1.8 |
| Sedation | Patient Global Impression of Change (PGIC) | 4.5 score on a scale | Standard Deviation 2 |
| Standard Care | Patient Global Impression of Change (PGIC) | 4.6 score on a scale | Standard Deviation 1.9 |
Secondary
Percentage Change of the Spectral Edge Frequency (SEF)
Frontal EEG sensor will be placed with electrode positions corresponding to Fp1, Fp2, F7, and F8 in the international 10-20 system. The spectral edge frequency (SEF) on the Sedline monitor ranges in frequency from 0 to 30 Hz.
Time frame: During the procedure for up to 20 minutes
Population: The bifrontal EEG was used in an arbitrary subgroup of participants based on the availability of the EEG.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) | Percentage Change of the Spectral Edge Frequency (SEF) | 0.56 percentage change | Standard Deviation 5.44 |
| Sedation | Percentage Change of the Spectral Edge Frequency (SEF) | 64.05 percentage change | Standard Deviation 44.35 |
| Standard Care | Percentage Change of the Spectral Edge Frequency (SEF) | 53.43 percentage change | Standard Deviation 19.16 |
Secondary
Procedure-related Anxiety
This outcome was measured using a standalone question using the 1-5 Likert scale (1=extreme anxiety, 2=high anxiety, 3=average or expected anxiety, 4=minimal or mild anxiety, 5=no anxiety. A mean of the participant selection is reported.
Time frame: In postanesthetic care unit (within 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) | Procedure-related Anxiety | 4.0 score on a scale | Standard Deviation 1.3 |
| Sedation | Procedure-related Anxiety | 4.2 score on a scale | Standard Deviation 1.1 |
| Standard Care | Procedure-related Anxiety | 3.8 score on a scale | Standard Deviation 1.1 |
Secondary
Procedure Satisfaction
This outcome was measured using a standalone question using the 1-5 Likert scale (1= very unsatisfied, 3= neither satisfied nor dissatisfied, 5= very satisfied). A mean of the participant selection is reported.
Time frame: In postanesthetic care unit (within 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) | Procedure Satisfaction | 4.7 score on a scale | Standard Deviation 0.6 |
| Sedation | Procedure Satisfaction | 4.6 score on a scale | Standard Deviation 0.8 |
| Standard Care | Procedure Satisfaction | 4.5 score on a scale | Standard Deviation 0.7 |
Secondary
Subcutaneous Skin Wheal Pain Score
0-10 verbal rating scale (higher scores indicate greater pain)
Time frame: Immediately after skin wheal
Population: Skin wheels were unintentionally omitted in two participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) | Subcutaneous Skin Wheal Pain Score | 4.0 score on a scale | Standard Deviation 2.4 |
| Sedation | Subcutaneous Skin Wheal Pain Score | 3.8 score on a scale | Standard Deviation 2.8 |
| Standard Care | Subcutaneous Skin Wheal Pain Score | 4.5 score on a scale | Standard Deviation 2.8 |
Secondary
Time to Discharge From Postanesthetic Care Unit
Time to discharge from postanesthetic care unit, in minutes
Time frame: At discharge from postanesthetic care unit assessed up to 6 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Virtual Reality (VR) | Time to Discharge From Postanesthetic Care Unit | 27.0 minutes |
| Sedation | Time to Discharge From Postanesthetic Care Unit | 38.8 minutes |
| Standard Care | Time to Discharge From Postanesthetic Care Unit | 24.4 minutes |
Secondary
Worst Back Pain Score
Worst back pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)
Time frame: 4 weeks
Population: Participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) | Worst Back Pain Score | 5.1 score on a scale | Standard Deviation 3.5 |
| Sedation | Worst Back Pain Score | 5.5 score on a scale | Standard Deviation 3.3 |
| Standard Care | Worst Back Pain Score | 5.5 score on a scale | Standard Deviation 3.1 |
Secondary
Worst Leg Pain Score
Worst leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)
Time frame: 4 weeks
Population: Participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) | Worst Leg Pain Score | 4.9 score on a scale | Standard Deviation 3.3 |
| Sedation | Worst Leg Pain Score | 4.8 score on a scale | Standard Deviation 3.4 |
| Standard Care | Worst Leg Pain Score | 5.8 score on a scale | Standard Deviation 2.9 |