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| ID | Type | Description | Link |
|---|---|---|---|
| HU00011920011 | Other Grant/Funding Number | Department Of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| The Geneva Foundation | OTHER |
| Walter Reed National Military Medical Center | FED |
| United States Naval Medical Center, San Diego |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality (VR) | Experimental | Subjects in the VR group will be fitted with an HTC headset and headphones with disposable ear covers. They will choose from a menu of 6 different programs. They will also receive 1% superficial anesthesia. |
|
| Sedation | Active Comparator | Conscious sedation will be accomplished by the use of 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). All medications will be titrated to conscious sedation by a board-certified anesthesiologist. Subjects will also receive 1% superficial anesthesia. |
|
| Standard care | Other | Patients in this arm will be administered only 1% lidocaine as superficial anesthesia, similar to the other 2 arms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score During Procedure | 0-10 verbal rating scale (higher scores indicate greater pain) | Immediately after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Local Anesthetic Required | Volume of 1% lidocaine used to complete the skin wheel prior to the procedure. | At the start of the procedure |
| Subcutaneous Skin Wheal Pain Score | 0-10 verbal rating scale (higher scores indicate greater pain) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Whitley Lucio | Walter Reed National Military Medical Center | Study Director |
| Steven P Cohen, MD | Johns Hopkins Uinversity - SOM Ane Pain | Principal Investigator |
| Nuj Tontisirin, MD | Ramathibodi Hospital, Mahidol University | Study Director |
| Pornpan Chalermkitpanit, MD | King Chulalongkorn Memorial Hospital, Chulalongkorn University | Study Director |
| Pramote Euasobhon, MD | Siriraj Hospital | Study Director |
| Sithapan Munjupong, MD | Phramongkutklao College of Medicine | Study Director |
| Qian Chen, MD | NYU Langone Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medical Institutions | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29485536 | Result | Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599. | |
| 31308733 | Result | Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019. |
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Protocol, Informed Consent Form, deidentified data and statistical code.
6 months after publication until 3 years
By e-mail request, upon approval by Dept. of Defense
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Reality (VR) | Subjects in the VR group will be fitted with an HTC headset and headphones with disposable ear covers. They will choose from a menu of 6 different programs. The participants 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score During Procedure | 0-10 verbal rating scale (higher scores indicate greater pain) | Posted | Mean | Standard Deviation | score on a scale | Immediately after procedure |
|
Up to 4 weeks post-procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Reality (VR) | Subjects in the VR group will be fitted with an HTC headset and headphones with disposable ear covers. They will choose from a menu of 6 different programs. They 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | SNOMED CT | Systematic Assessment | Nausea |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven P. Cohen | Northwestern University | 312-695-2500 | steven.cohen@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2022 | Jun 11, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 15, 2022 | Jun 20, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| FED |
| Brigham and Women's Hospital | OTHER |
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.
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Outcome assessor will be unaware of treatment allocation but the patient and provider cannot be.
| Intravenous sedation | Drug | 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. |
|
| Standard care | Other | Patients will receive superficial local anesthetic with 1% lidocaine. Local anesthetic will be administered by the physician performing the procedure titrated to patient comfort. |
|
|
| Immediately after skin wheal |
| 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. | In postanesthetic care unit (within 1 hour) |
| 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. | In postanesthetic care unit (within 1 hour) |
| 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. | In postanesthetic care unit (within 1 hour) |
| Time to Discharge From Postanesthetic Care Unit | Time to discharge from postanesthetic care unit, in minutes | At discharge from postanesthetic care unit assessed up to 6 hours |
| 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. | 4 weeks |
| Average Leg Pain Score | Average leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain) | 4 weeks |
| Worst Leg Pain Score | Worst leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain) | 4 weeks |
| Average Back Pain Score | Average back pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain) | 4 weeks |
| Worst Back Pain Score | Worst back pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain) | 4 weeks |
| 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) | 4 weeks |
| Number of Participants With Analgesic Reduction | Categorical reduction in analgesic usage (cessation of non-opioid analgesic and/ or > 20% reduction in opioid use) | 4 weeks |
| Oswestry Disability Index (ODI) Score | Functional measurement of back and leg pain disability on 0-100% scale (higher levels indicate greater disability) | 4 weeks |
| 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. | 4 weeks |
| Number of Participants With Complications | Number of Participants With Complications related to the procedure, sedation or use of virtual reality | 4 weeks |
| 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. | During the procedure for up to 20 minutes |
| 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. | 4 weeks |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | 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. |
|
|
| Secondary | Amount of Local Anesthetic Required | Volume of 1% lidocaine used to complete the skin wheel prior to the procedure. | Posted | Mean | Standard Deviation | milliliters | At the start of the procedure |
|
|
|
| Secondary | Subcutaneous Skin Wheal Pain Score | 0-10 verbal rating scale (higher scores indicate greater pain) | Skin wheels were unintentionally omitted in two participants. | Posted | Mean | Standard Deviation | score on a scale | Immediately after skin wheal |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | In postanesthetic care unit (within 1 hour) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | In postanesthetic care unit (within 1 hour) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | In postanesthetic care unit (within 1 hour) |
|
|
|
| Secondary | Time to Discharge From Postanesthetic Care Unit | Time to discharge from postanesthetic care unit, in minutes | Posted | Mean | 95% Confidence Interval | minutes | At discharge from postanesthetic care unit assessed up to 6 hours |
|
|
|
| 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. | Participants who completed the study | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| 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) | Participants who completed the study | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| 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) | Participants who completed the study | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| 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) | Participants who completed the study | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| 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) | Participants who completed the study | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| 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) | Participants who completed the study | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| Secondary | Number of Participants With Analgesic Reduction | Categorical reduction in analgesic usage (cessation of non-opioid analgesic and/ or > 20% reduction in opioid use) | 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. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | Oswestry Disability Index (ODI) Score | Functional measurement of back and leg pain disability on 0-100% scale (higher levels indicate greater disability) | Participants who completed the study | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| 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. | Participants who completed the study | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| Secondary | Number of Participants With Complications | Number of Participants With Complications related to the procedure, sedation or use of virtual reality | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| 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. | The bifrontal EEG was used in an arbitrary subgroup of participants based on the availability of the EEG. | Posted | Mean | Standard Deviation | percentage change | During the procedure for up to 20 minutes |
|
|
|
| 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. | Participants who completed the study | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 5 |
| 48 |
| EG001 | Sedation | Conscious sedation will be accomplished by the use of 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). 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. 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. | 0 | 50 | 0 | 50 | 10 | 50 |
| EG002 | 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. | 0 | 48 | 0 | 48 | 4 | 48 |
| Vomiting | Gastrointestinal disorders | SNOMED CT | Systematic Assessment | Vomiting |
|
| Respiratory Depression | Respiratory, thoracic and mediastinal disorders | SNOMED CT | Systematic Assessment | Respiratory Depression |
|
| Dizziness | Ear and labyrinth disorders | SNOMED CT | Systematic Assessment | Dizziness |
|
| Severe pain | Nervous system disorders | SNOMED CT | Systematic Assessment | Severe pain |
|
| Tachycardia | Cardiac disorders | SNOMED CT | Systematic Assessment | Tachycardia |
|
| Diaphoresis | Cardiac disorders | SNOMED CT | Systematic Assessment | Diaphoresis |
|
| Shingles | Skin and subcutaneous tissue disorders | SNOMED CT | Systematic Assessment | Shingles |
|
| Procedure site swelling | Skin and subcutaneous tissue disorders | SNOMED CT | Systematic Assessment | Procedure site swelling |
|
| Dural Puncture | Nervous system disorders | SNOMED CT | Systematic Assessment | Dural Puncture |
|
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |