Trial Outcomes & Findings for Virtual Reality as a Substitute for Procedural Sedation During Epidural Steroid Injections (NCT NCT04887285)

NCT ID: NCT04887285

Last Updated: 2024-12-02

Results Overview

0-10 verbal rating scale (higher scores indicate greater pain)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 146 participants
• Primary outcome timeframe: Immediately after procedure
• Results posted on: 2024-12-02

Participant Flow

Participant milestones

Measure	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.	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.	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.
Overall Study STARTED	48	50	48
Overall Study COMPLETED	48	48	45
Overall Study NOT COMPLETED	0	2	3

Reasons for withdrawal

Measure	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.	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.	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.
Overall Study Lost to Follow-up	0	2	3

Baseline Characteristics

Virtual Reality as a Substitute for Procedural Sedation During Epidural Steroid Injections

Baseline characteristics by cohort

Measure	Virtual Reality (VR) n=48 Participants 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.	Sedation n=50 Participants 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.	Standard Care n=48 Participants 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.	Total n=146 Participants Total of all reporting groups
Age, Continuous	57 years STANDARD_DEVIATION 13 • n=5 Participants	58 years STANDARD_DEVIATION 13 • n=7 Participants	56 years STANDARD_DEVIATION 16 • n=5 Participants	57 years STANDARD_DEVIATION 14 • n=4 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	37 Participants n=7 Participants	27 Participants n=5 Participants	95 Participants n=4 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants	51 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants	50 Participants n=7 Participants	47 Participants n=5 Participants	144 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	26 Participants n=5 Participants	22 Participants n=7 Participants	25 Participants n=5 Participants	73 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	17 Participants n=7 Participants	13 Participants n=5 Participants	39 Participants n=4 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	27 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment United States	27 Participants n=5 Participants	31 Participants n=7 Participants	29 Participants n=5 Participants	87 Participants n=4 Participants
Region of Enrollment Thailand	21 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	59 Participants n=4 Participants

PRIMARY outcome

Timeframe: Immediately after procedure

0-10 verbal rating scale (higher scores indicate greater pain)

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=50 Participants 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.	Standard Care n=48 Participants 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.
Pain Score During Procedure	3.7 score on a scale Standard Deviation 2.5	3.2 score on a scale Standard Deviation 3.0	5.2 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: At the start of the procedure

Volume of 1% lidocaine used to complete the skin wheel prior to the procedure.

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=50 Participants 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.	Standard Care n=48 Participants 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.
Amount of Local Anesthetic Required	5.6 milliliters Standard Deviation 2.5	5.4 milliliters Standard Deviation 2.6	6.3 milliliters Standard Deviation 2.9

SECONDARY outcome

Timeframe: Immediately after skin wheal

Population: Skin wheels were unintentionally omitted in two participants.

0-10 verbal rating scale (higher scores indicate greater pain)

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=49 Participants 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.	Standard Care n=47 Participants 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.
Subcutaneous Skin Wheal Pain Score	4.0 score on a scale Standard Deviation 2.4	3.8 score on a scale Standard Deviation 2.8	4.5 score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=50 Participants 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.	Standard Care n=48 Participants 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.
Procedure Satisfaction	4.7 score on a scale Standard Deviation 0.6	4.6 score on a scale Standard Deviation 0.8	4.5 score on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=50 Participants 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.	Standard Care n=48 Participants 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.
Ability to Communicate	4.1 score on a scale Standard Deviation 0.5	3.7 score on a scale Standard Deviation 0.9	4.0 score on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=50 Participants 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.	Standard Care n=48 Participants 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.
Procedure-related Anxiety	4.0 score on a scale Standard Deviation 1.3	4.2 score on a scale Standard Deviation 1.1	3.8 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: At discharge from postanesthetic care unit assessed up to 6 hours

Time to discharge from postanesthetic care unit, in minutes

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=50 Participants 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.	Standard Care n=48 Participants 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.
Time to Discharge From Postanesthetic Care Unit	27.0 minutes Interval 21.0 to 33.0	38.8 minutes Interval 34.7 to 42.9	24.4 minutes Interval 17.4 to 31.4

SECONDARY outcome

Timeframe: 4 weeks

Population: Participants who completed the study

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.

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=48 Participants 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.	Standard Care n=45 Participants 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.
Participants With Positive Categorical Outcome	25 Participants	25 Participants	24 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Participants who completed the study

Average leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=48 Participants 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.	Standard Care n=45 Participants 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.
Average Leg Pain Score	3.0 score on a scale Standard Deviation 2.4	3.1 score on a scale Standard Deviation 4.8	3.8 score on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 4 weeks

Population: Participants who completed the study

Worst leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=48 Participants 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.	Standard Care n=45 Participants 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.
Worst Leg Pain Score	4.9 score on a scale Standard Deviation 3.3	4.8 score on a scale Standard Deviation 3.4	5.8 score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: 4 weeks

Population: Participants who completed the study

Average back pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=48 Participants 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.	Standard Care n=45 Participants 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.
Average Back Pain Score	3.1 score on a scale Standard Deviation 2.3	3.5 score on a scale Standard Deviation 2.6	3.6 score on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 4 weeks

Population: Participants who completed the study

Worst back pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=48 Participants 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.	Standard Care n=45 Participants 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.
Worst Back Pain Score	5.1 score on a scale Standard Deviation 3.5	5.5 score on a scale Standard Deviation 3.3	5.5 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: 4 weeks

Population: Participants who completed the study

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)

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=48 Participants 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.	Standard Care n=45 Participants 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.
Patient Global Impression of Change (PGIC)	4.7 score on a scale Standard Deviation 1.8	4.5 score on a scale Standard Deviation 2.0	4.6 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 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.

Categorical reduction in analgesic usage (cessation of non-opioid analgesic and/ or > 20% reduction in opioid use)

Outcome measures

Measure	Virtual Reality (VR) n=46 Participants 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. 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.	Sedation n=44 Participants 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.	Standard Care n=40 Participants 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.
Number of Participants With Analgesic Reduction	16 Participants	19 Participants	7 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Participants who completed the study

Functional measurement of back and leg pain disability on 0-100% scale (higher levels indicate greater disability)

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=48 Participants 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.	Standard Care n=45 Participants 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.
Oswestry Disability Index (ODI) Score	32 score on a scale Standard Deviation 17	36 score on a scale Standard Deviation 17	34 score on a scale Standard Deviation 15

SECONDARY outcome

Timeframe: 4 weeks

Population: Participants who completed the study

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.

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=48 Participants 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.	Standard Care n=45 Participants 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.
Hospital Anxiety and Depression Scale (HADS) Scores for Anxiety and Depressions	4.9 score on a scale Standard Deviation 4.0	5.1 score on a scale Standard Deviation 4.5	4.3 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: 4 weeks

Number of Participants With Complications related to the procedure, sedation or use of virtual reality

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=50 Participants 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.	Standard Care n=48 Participants 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.
Number of Participants With Complications	5 Participants	10 Participants	4 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Virtual Reality (VR) n=4 Participants 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. 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.	Sedation n=6 Participants 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.	Standard Care n=6 Participants 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.
Percentage Change of the Spectral Edge Frequency (SEF)	0.56 percentage change Standard Deviation 5.44	64.05 percentage change Standard Deviation 44.35	53.43 percentage change Standard Deviation 19.16

SECONDARY outcome

Timeframe: 4 weeks

Population: Participants who completed the study

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.

Outcome measures

Measure	Virtual Reality (VR) n=48 Participants 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. 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.	Sedation n=48 Participants 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.	Standard Care n=45 Participants 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.
Hospital Anxiety and Depression Scale (HADS) Scores for Depression and Anxiety	4.0 score on a scale Standard Deviation 3.9	4.5 score on a scale Standard Deviation 3.9	3.8 score on a scale Standard Deviation 3.5

Adverse Events

Virtual Reality (VR)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Sedation

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Virtual Reality (VR) n=48 participants at risk 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.	Sedation n=50 participants at risk 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.	Standard Care n=48 participants at risk 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.
Gastrointestinal disorders Nausea	4.2% 2/48 • Number of events 2 • Up to 4 weeks post-procedure	2.0% 1/50 • Number of events 1 • Up to 4 weeks post-procedure	0.00% 0/48 • Up to 4 weeks post-procedure
Gastrointestinal disorders Vomiting	2.1% 1/48 • Number of events 1 • Up to 4 weeks post-procedure	2.0% 1/50 • Number of events 1 • Up to 4 weeks post-procedure	0.00% 0/48 • Up to 4 weeks post-procedure
Respiratory, thoracic and mediastinal disorders Respiratory Depression	0.00% 0/48 • Up to 4 weeks post-procedure	4.0% 2/50 • Number of events 2 • Up to 4 weeks post-procedure	0.00% 0/48 • Up to 4 weeks post-procedure
Ear and labyrinth disorders Dizziness	2.1% 1/48 • Number of events 1 • Up to 4 weeks post-procedure	100.0% 3/3 • Number of events 3 • Up to 4 weeks post-procedure	2.1% 1/48 • Number of events 1 • Up to 4 weeks post-procedure
Nervous system disorders Severe pain	2.1% 1/48 • Number of events 1 • Up to 4 weeks post-procedure	4.0% 2/50 • Number of events 2 • Up to 4 weeks post-procedure	0.00% 0/48 • Up to 4 weeks post-procedure
Cardiac disorders Tachycardia	0.00% 0/48 • Up to 4 weeks post-procedure	0.00% 0/50 • Up to 4 weeks post-procedure	4.2% 2/48 • Number of events 2 • Up to 4 weeks post-procedure
Cardiac disorders Diaphoresis	0.00% 0/48 • Up to 4 weeks post-procedure	0.00% 0/50 • Up to 4 weeks post-procedure	2.1% 1/48 • Number of events 1 • Up to 4 weeks post-procedure
Skin and subcutaneous tissue disorders Shingles	2.1% 1/48 • Number of events 1 • Up to 4 weeks post-procedure	0.00% 0/50 • Up to 4 weeks post-procedure	0.00% 0/48 • Up to 4 weeks post-procedure
Skin and subcutaneous tissue disorders Procedure site swelling	2.1% 1/48 • Number of events 1 • Up to 4 weeks post-procedure	0.00% 0/50 • Up to 4 weeks post-procedure	0.00% 0/48 • Up to 4 weeks post-procedure
Nervous system disorders Dural Puncture	0.00% 0/48 • Up to 4 weeks post-procedure	2.0% 1/50 • Number of events 1 • Up to 4 weeks post-procedure	0.00% 0/48 • Up to 4 weeks post-procedure

Additional Information

Steven P. Cohen

Northwestern University

Phone: 312-695-2500

Email: steven.cohen@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place