Trial Outcomes & Findings for Virtual Reality After Pediatric Scoliosis Surgery (NCT NCT04584970)

Results Overview

All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

Recorded preoperatively as baseline

Results posted on

2022-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	Virtual Reality Device Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Applied VR: The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.	iPad Device Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Apple iPad: The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.
Overall Study STARTED	11	12
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Virtual Reality After Pediatric Scoliosis Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Reality Device n=11 Participants Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Applied VR: The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.	iPad Device n=12 Participants Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Apple iPad: The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.	Total n=23 Participants Total of all reporting groups
Age, Customized Aged 11-14	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Age, Customized Aged 15-17	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: Recorded preoperatively as baseline

All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Virtual Reality Device n=11 Participants Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Applied VR: The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.	iPad Device n=12 Participants Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Apple iPad: The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.
Pain Scores Via FACES Scale by Patient at Baseline	0.91 score on a scale Interval 0.0 to 4.0	0.92 score on a scale Interval 0.0 to 6.0

PRIMARY outcome

Timeframe: Recorded immediately prior to intervention (T=0 min)

Population: Data not included for participants who withdrew from study

All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome. Assessed immediately prior to first intervention exposure (T=0 min) during 1 30-minute session on day 1 postoperatively.

Outcome measures

Outcome measures
Measure	Virtual Reality Device n=10 Participants Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Applied VR: The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.	iPad Device n=9 Participants Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Apple iPad: The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.
Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=0	5.00 score on a scale Interval 0.0 to 10.0	4.22 score on a scale Interval 0.0 to 8.0

PRIMARY outcome

Timeframe: Recorded at end of intervention (T=30 minutes)

Population: Data not included for participants who withdrew from study.

All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome. Assessed immediately after first intervention exposure (T=30 min) following 1 30-minute session on day 1 postoperatively.

Outcome measures

Outcome measures
Measure	Virtual Reality Device n=10 Participants Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Applied VR: The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.	iPad Device n=9 Participants Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Apple iPad: The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.
Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=30	3.80 score on a scale Interval 0.0 to 8.0	3.55 score on a scale Interval 0.0 to 6.0

PRIMARY outcome

Timeframe: Recorded preoperatively as baseline

The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Virtual Reality Device n=11 Participants Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Applied VR: The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.	iPad Device n=12 Participants Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Apple iPad: The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.
Pain Scores Via FLACC Scale by Research Assistant at Baseline	0 score on a scale Standard Deviation 0	1.5 score on a scale Standard Deviation 3.12

PRIMARY outcome

Timeframe: Recorded immediately prior to intervention (T=0 minutes)

Population: Data not included for participants who withdrew from study.

The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Assessed immediately prior to first intervention exposure (T=0 min) during 1 30-minute session on day 1 postoperatively.

Outcome measures

Outcome measures
Measure	Virtual Reality Device n=10 Participants Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Applied VR: The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.	iPad Device n=9 Participants Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Apple iPad: The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.
Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=0	0.60 score on a scale Standard Deviation 1.07	0.33 score on a scale Standard Deviation 0.71

PRIMARY outcome

Timeframe: Recorded at the 10 minute mark (T=10 minutes)

Population: Data not included for participants who withdrew from study.

The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Assessed immediately during first intervention exposure (T=10 min) during 1 30-minute session on day 1 postoperatively.

Outcome measures

Outcome measures
Measure	Virtual Reality Device n=10 Participants Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Applied VR: The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.	iPad Device n=9 Participants Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Apple iPad: The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.
Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=10	0 score on a scale Standard Deviation 0	0.44 score on a scale Standard Deviation 1.33

PRIMARY outcome

Timeframe: Recorded at end of intervention (T=30 minutes)

Population: Data not included for participants who withdrew from study. Data are included for those participants who interacted with the intervention for the full 30-minute time limit.

The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Participants were allowed to play/interact with intervention for up to 30 minutes. Assessed immediately following first intervention exposure (T=30 min) following 1 30-minute session on day 1 postoperatively.

Outcome measures

Outcome measures
Measure	Virtual Reality Device n=5 Participants Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Applied VR: The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.	iPad Device n=7 Participants Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Apple iPad: The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.
Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=30	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: Recorded for the hour prior to intervention (T=-60-0 minutes)

Population: PCA pumps were no longer in use by the time the study intervention was employed; therefore, these data were not collected.

Opioid use via Patient-Controlled Analgesia (PCA) pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Recorded during intervention (T=0-30 minutes)

Population: PCA pumps were no longer in use by the time the study intervention was employed; therefore, these data were not collected.

Opioid use via PCA pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Recorded one hour after intervention is complete (T=30-90 minutes)

Population: PCA pumps were no longer in use by the time the study intervention was employed; therefore, these data were not collected.

Opioid use via PCA pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From anesthesia end through hospital discharge, a total of approximately 2 days

Population: Data not included for participants who withdrew from study.

The amount of opioids used by the patient will be recorded in all subjects and converted into milligram morphine equivalents based on chart reviews. This collection method was added to replace PCA pump usage unavailability.

Outcome measures

Outcome measures
Measure	Virtual Reality Device n=10 Participants Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Applied VR: The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.	iPad Device n=9 Participants Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Apple iPad: The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.
Total Opioid Dose (in Milligram Morphine Equivalents)	4.74 (mg) morphine equivalents Standard Deviation 1.19	5.27 (mg) morphine equivalents Standard Deviation 1.52

SECONDARY outcome

Timeframe: Assessed at time of intervention on postoperative day #1

Population: Data not included for participants who withdrew from study and an additional 2 participants for whom data were inadvertently not recorded.

VR device or iPad use in minutes. Minimal 0 minutes, maximum 60 minutes (30 minutes x 2 sessions). A higher number indicates more electronic device use, which is neither a better or worse outcome, but rather provides information about whether devices were used for the full allotted time or not.

Outcome measures

Outcome measures
Measure	Virtual Reality Device n=9 Participants Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Applied VR: The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.	iPad Device n=8 Participants Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Apple iPad: The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.
Electronic Device Use	20.33 minutes Standard Deviation 7.58	26.38 minutes Standard Deviation 4.44

SECONDARY outcome

Timeframe: Recorded preoperatively as baseline

Population: Data were not collected for 1 participant in the iPad device group.

The State-Trait Anxiety Inventory (STAI) Short Form scoring tool is a self-report questionnaire. It contains 6 statements (i.e., 'I feel calm', with 1=Not at all, 2=Somewhat, 3=Moderately, 4=Very much). Scores range from 6-24, with 6 signifying no anxiety and 24 points signifying the highest level of anxiety. Higher score indicates a worse outcome.