Trial Outcomes & Findings for Adolescent Responses to Varying Environments in Virtual Reality Simulations (NCT NCT04465240)

Last Updated: 2024-06-07

Results Overview

Multiple measures were used for emotion felt in the VR neighborhood: 1. Participants rate how strongly they felt 9 specific emotions (0-8 scale; 0 indicates none, 8 is the strongest possible feeling). 2. Two composite scores based on averaging responses for specific emotions: Positive emotion (enthusiasm, contentment, amusement) and Negative emotion (fear, sadness, disgust, anger). Averages were based on the standard score representing standard deviations above/below the mean. The mean score was 0. Positive emotion ranged from -1.9, the lowest positive emotion, to 2.0, the highest. Negative emotion ranged from -0.7, the lowest negative emotion, to 3.5, the highest. A positive score reflects greater than average for that type of emotion, and negative score reflects less than average for that type of emotion. 3. Self-Assessment Manikin (SAM) scale: two dimensional scales for how they felt, from (a) happy to unhappy (1 to 9), and (b) excited to calm (1 to 9) (Bradley \& Lang, 1994)

Recruitment status

COMPLETED

Study phase

Target enrollment

107 participants

Primary outcome timeframe

Immediately after the virtual reality task (average of 28 minutes post baseline)

Results posted on

2024-06-07

Participant Flow

While 107 participants were enrolled, eight withdrew after enrollment but prior to randomization to condition, without attending the single study session. Thus while enrollment was 107 the total started in the protocol flow was 99.

Participant milestones

Participant milestones
Measure	Virtual Reality Simulation of Neighborhood Disadvantage Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood representative of disadvantage they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality	Virtual Reality Simulation of Neighborhood Affluence Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood, representative of affluence they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality
Overall Study STARTED	50	49
Overall Study COMPLETED	50	49
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One address could not be accurately geocoded and assigned a U.S. census tract, leading to one fewer participant for this baseline measure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Reality Simulation of Neighborhood Disadvantage n=50 Participants Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood representative of disadvantage they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality	Virtual Reality Simulation of Neighborhood Affluence n=49 Participants Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood, representative of affluence they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality	Total n=99 Participants Total of all reporting groups
Age, Continuous	16.03 years STANDARD_DEVIATION 1.06 • n=50 Participants	15.85 years STANDARD_DEVIATION 1.16 • n=49 Participants	15.94 years STANDARD_DEVIATION 1.11 • n=99 Participants
Sex: Female, Male Female	20 Participants n=50 Participants	16 Participants n=49 Participants	36 Participants n=99 Participants
Sex: Female, Male Male	30 Participants n=50 Participants	33 Participants n=49 Participants	63 Participants n=99 Participants
Race/Ethnicity, Customized African American / Black	3 Participants n=50 Participants	2 Participants n=49 Participants	5 Participants n=99 Participants
Race/Ethnicity, Customized Asian	6 Participants n=50 Participants	5 Participants n=49 Participants	11 Participants n=99 Participants
Race/Ethnicity, Customized Latinx / Hispanic	21 Participants n=50 Participants	19 Participants n=49 Participants	40 Participants n=99 Participants
Race/Ethnicity, Customized Multiracial	6 Participants n=50 Participants	4 Participants n=49 Participants	10 Participants n=99 Participants
Race/Ethnicity, Customized Native American, American Indian or Alaskan Native	0 Participants n=50 Participants	2 Participants n=49 Participants	2 Participants n=99 Participants
Race/Ethnicity, Customized Other	1 Participants n=50 Participants	0 Participants n=49 Participants	1 Participants n=99 Participants
Race/Ethnicity, Customized White	13 Participants n=50 Participants	17 Participants n=49 Participants	30 Participants n=99 Participants
Parental Education High School Education or Less	5 Participants n=50 Participants	4 Participants n=49 Participants	9 Participants n=99 Participants
Parental Education Some College or Associate's Degree	7 Participants n=50 Participants	2 Participants n=49 Participants	9 Participants n=99 Participants
Parental Education Bachelor's Degree	20 Participants n=50 Participants	21 Participants n=49 Participants	41 Participants n=99 Participants
Parental Education Master's Degree	13 Participants n=50 Participants	16 Participants n=49 Participants	29 Participants n=99 Participants
Parental Education Doctoral Degree or Equivalent	5 Participants n=50 Participants	6 Participants n=49 Participants	11 Participants n=99 Participants
Neighborhood Poverty Rate	11.56 % below poverty in neighborhood STANDARD_DEVIATION 11.02 • n=50 Participants • One address could not be accurately geocoded and assigned a U.S. census tract, leading to one fewer participant for this baseline measure	9.82 % below poverty in neighborhood STANDARD_DEVIATION 8.3 • n=48 Participants • One address could not be accurately geocoded and assigned a U.S. census tract, leading to one fewer participant for this baseline measure	10.71 % below poverty in neighborhood STANDARD_DEVIATION 9.77 • n=98 Participants • One address could not be accurately geocoded and assigned a U.S. census tract, leading to one fewer participant for this baseline measure

PRIMARY outcome

Timeframe: Immediately after the virtual reality task (average of 28 minutes post baseline)

Population: Two participants (one from each arm) were excluded from analyses due to major technical problems / glitches in virtual reality presentation that lead to invalid data. One participant did not complete the measure of happy/unhappy

Outcome measures

Outcome measures
Measure	Virtual Reality Simulation of Neighborhood Disadvantage n=49 Participants Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood representative of disadvantage they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality	Virtual Reality Simulation of Neighborhood Affluence n=48 Participants Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood, representative of affluence they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality
Emotional Response Amusement: from 0 (not at all) to 8 (strongest ever felt)	3.65 units on a scale Standard Deviation 1.82	4.31 units on a scale Standard Deviation 1.75
Emotional Response Anger: from 0 (not at all) to 8 (strongest ever felt)	1.29 units on a scale Standard Deviation 1.89	0.33 units on a scale Standard Deviation 0.81
Emotional Response Contentment / Happiness: from 0 (not at all) to 8 (strongest ever felt)	2.98 units on a scale Standard Deviation 1.65	4.54 units on a scale Standard Deviation 1.88
Emotional Response Compassion: from 0 (not at all) to 8 (strongest ever felt)	3.18 units on a scale Standard Deviation 2.09	2.56 units on a scale Standard Deviation 2.32
Emotional Response Disgust: from 0 (not at all) to 8 (strongest ever felt)	2.86 units on a scale Standard Deviation 2.42	0.69 units on a scale Standard Deviation 1.36
Emotional Response Enthusiasm/excitement: from 0 (not at all) to 8 (strongest ever felt)	2.69 units on a scale Standard Deviation 1.97	3.77 units on a scale Standard Deviation 2.21
Emotional Response Sadness: from 0 (not at all) to 8 (strongest ever felt)	2.67 units on a scale Standard Deviation 2.37	0.33 units on a scale Standard Deviation 0.69
Emotional Response Surprise: from 0 (not at all) to 8 (strongest ever felt)	2.84 units on a scale Standard Deviation 2.31	2.79 units on a scale Standard Deviation 2.62
Emotional Response Positive Emotion: Composite based on enthusiasm, contentment, amusement (Overall mean is 0)	-0.28 units on a scale Standard Deviation 0.76	0.28 units on a scale Standard Deviation 0.91
Emotional Response Negative Emotion: Composite based on fear, sadness, disgust, anger (Overall mean is 0)	0.41 units on a scale Standard Deviation 0.98	-0.42 units on a scale Standard Deviation 0.34
Emotional Response Fear: from 0 (not at all) to 8 (strongest ever felt)	1.59 units on a scale Standard Deviation 2.21	0.44 units on a scale Standard Deviation 0.92
Emotional Response Happy-Unhappy: from 1 (happy) to 9 (unhappy) [Self-Assessment Manikin (SAM)]	4.58 units on a scale Standard Deviation 1.66	3.4 units on a scale Standard Deviation 1.61
Emotional Response Excited-calm: from 1 (excited) to 9 (calm) [Self-Assessment Manikin (SAM)]	5.39 units on a scale Standard Deviation 1.96	5.85 units on a scale Standard Deviation 1.98

PRIMARY outcome

Timeframe: Measured 5 times: (1) end of baseline, (2) after virtual reality (VR) neighborhood (VR: 11 minutes, average), (3) after questionnaires (26 minutes after VR end, average), (4) video (recovery), after first 15 minutes, (5) after final 15 minutes of video

Population: Two participants (one from each arm) were excluded from analyses due to major technical problems / glitches in virtual reality that lead to invalid data. Sixteen participants (7 in virtual affluent condition, 9 in virtual disadvantaged condition) were removed due potential contamination between saliva samples across time in the study session.

Concentration of the stress hormone cortisol in saliva samples, measured in (µg/dL), that participants provide over the course of the study session to assess cortisol response

Outcome measures

Outcome measures
Measure	Virtual Reality Simulation of Neighborhood Disadvantage n=40 Participants Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood representative of disadvantage they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality	Virtual Reality Simulation of Neighborhood Affluence n=41 Participants Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood, representative of affluence they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality
Salivary Cortisol Baseline (end)	0.121 µg/dL Standard Deviation 0.063	0.135 µg/dL Standard Deviation 0.123
Salivary Cortisol Virtual Reality Neighborhood (immediately after)	0.134 µg/dL Standard Deviation 0.066	0.182 µg/dL Standard Deviation 0.156
Salivary Cortisol Questionnaire completion	0.251 µg/dL Standard Deviation 0.333	0.287 µg/dL Standard Deviation 0.395
Salivary Cortisol Video, After 15 minutes	0.261 µg/dL Standard Deviation 0.419	0.361 µg/dL Standard Deviation 0.584
Salivary Cortisol Video, After 30 minutes	0.279 µg/dL Standard Deviation 0.542	0.286 µg/dL Standard Deviation 0.473

PRIMARY outcome

Timeframe: Measured in 5 epochs, typical 60-90 minutes total: (1) Baseline before virtual reality (VR), (2) VR neighborhood (11 minutes, average), (3) Questionnaires (begins 6 minutes after VR end, average), (4) Video: first 15 minutes, (5) Video, final 15 minutes

Population: Two participants (one from each arm) were excluded from analyses due to major technical problems / glitches in virtual reality that lead to invalid data. One participant did not have blood pressure recordings and for one technical problems led to data not being recorded.

Systolic (SBP) and diastolic (DBP) blood pressure, in mmHG, measured and summarized across epochs in the study session.

Outcome measures

Outcome measures
Measure	Virtual Reality Simulation of Neighborhood Disadvantage n=47 Participants Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood representative of disadvantage they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality	Virtual Reality Simulation of Neighborhood Affluence n=48 Participants Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood, representative of affluence they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality
Blood Pressure SBP, Questionnaires (mean, in mmHg)	120.41 mmHG Standard Deviation 16.13	114.11 mmHG Standard Deviation 17.46
Blood Pressure SBP, Video, First 15 Minutes (mean, in mmHg)	115.29 mmHG Standard Deviation 20.16	113.02 mmHG Standard Deviation 23.54
Blood Pressure SBP, Baseline (mean, in mmHg)	120.45 mmHG Standard Deviation 17.65	117.79 mmHG Standard Deviation 19.78
Blood Pressure SBP, VR neighborhood (mean, in mmHg)	123.82 mmHG Standard Deviation 23.46	125.97 mmHG Standard Deviation 19.13
Blood Pressure SBP, Video, Second, 15 Minutes (mean, in mmHg)	110.90 mmHG Standard Deviation 22.62	113.79 mmHG Standard Deviation 17.52
Blood Pressure DBP, Baseline (mean, in mmHg)	70.14 mmHG Standard Deviation 13.64	66.23 mmHG Standard Deviation 13.65
Blood Pressure DBP, VR neighborhood (mean, in mmHg)	76.29 mmHG Standard Deviation 15.13	72.28 mmHG Standard Deviation 16.22
Blood Pressure DBP, Questionnaires (mean, in mmHg)	69.18 mmHG Standard Deviation 11.91	68.22 mmHG Standard Deviation 14.35
Blood Pressure DBP, Video, First 15 Minutes (mean, in mmHg)	70.50 mmHG Standard Deviation 15.91	67.31 mmHG Standard Deviation 17.29
Blood Pressure DBP, Video, Second 15 Minutes (mean, in mmHg)	66.07 mmHG Standard Deviation 13.89	67.20 mmHG Standard Deviation 11.22

PRIMARY outcome

Population: Two participants (one from each arm) were excluded from analyses due to major technical problems / glitches in virtual reality that lead to invalid data. One participant had technical problems led to data not being recorded, and another had minimal signal recorded across data collection.

Respiratory Sinus Arrhythmia (RSA) reflects parasympathetic nervous systemt activity and is used as an index of emotion regulation, with higher scores indicating greater parasympathetic activation. It is derived from the natural log of the power of high frequency heart rate variability (heart rate variability is the variability in the amount of time in between heart beats, and high frequency heart rate variability is the power of activity in the 0.15-0.4 Hz range). Based on electrocardiograph signals measured and summarized across epochs in the study session.

Outcome measures

Outcome measures
Measure	Virtual Reality Simulation of Neighborhood Disadvantage n=48 Participants Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood representative of disadvantage they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality	Virtual Reality Simulation of Neighborhood Affluence n=47 Participants Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood, representative of affluence they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality
Respiratory Sinus Arrhythmia (RSA) RSA, VR neighborhood (Mean)	6.88 ms-squared Standard Deviation 0.79	6.69 ms-squared Standard Deviation 1.15
Respiratory Sinus Arrhythmia (RSA) RSA, Baseline (Mean)	6.56 ms-squared Standard Deviation 0.90	6.31 ms-squared Standard Deviation 1.12
Respiratory Sinus Arrhythmia (RSA) RSA, Questionnaires (Mean)	6.77 ms-squared Standard Deviation 0.80	6.65 ms-squared Standard Deviation 1.16
Respiratory Sinus Arrhythmia (RSA) RSA, Video, First 15 Minutes (Mean)	6.76 ms-squared Standard Deviation 0.88	6.79 ms-squared Standard Deviation 1.04
Respiratory Sinus Arrhythmia (RSA) RSA, Video, Second 15 Minutes (Mean)	6.89 ms-squared Standard Deviation 0.82	6.90 ms-squared Standard Deviation 0.90

PRIMARY outcome

Population: Two participants (one from each arm) were excluded from analyses due to major technical problems / glitches in virtual reality that lead to invalid data. One participant had technical problems led to data not being recorded, and four had minimal or low quality signal recorded across data collection.

Cardiac Output (CO) represents the volume of blood pumped by the heart (L/min). Increasing values indicate greater volume of blood pumped per unit time. Derived from impedance cardiography signals measured and and then summarized across epochs in the study session.

Outcome measures

Outcome measures
Measure	Virtual Reality Simulation of Neighborhood Disadvantage n=47 Participants Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood representative of disadvantage they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality	Virtual Reality Simulation of Neighborhood Affluence n=45 Participants Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood, representative of affluence they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality
Cardiac Output (CO) CO, Baseline (mean)	5.35 L/min Standard Deviation 1.99	5.50 L/min Standard Deviation 2.13
Cardiac Output (CO) CO, Video, Second 15 Minutes (mean)	5.28 L/min Standard Deviation 1.72	5.15 L/min Standard Deviation 1.62
Cardiac Output (CO) CO, VR neighborhood (mean)	5.37 L/min Standard Deviation 1.79	5.90 L/min Standard Deviation 2.42
Cardiac Output (CO) CO, Questionnaires (mean)	5.18 L/min Standard Deviation 1.74	5.29 L/min Standard Deviation 1.70
Cardiac Output (CO) CO, Video, First 15 Minutes (mean)	5.30 L/min Standard Deviation 1.82	5.12 L/min Standard Deviation 1.73

PRIMARY outcome

Population: Two participants (one from each arm) were excluded from analyses due to major technical problems / glitches in virtual reality that lead to invalid data. One participant had technical problems led to data not being recorded, and four had minimal or low quality signal recorded across data collection.

Total peripheral resistance (TPR) is an index of an index of vasoconstriction (mean arterial pressure divided by cardiac output). Increasing values indicate greater vasoconstriction. Derived from impedance cardiography signals measured and and then summarized across epochs in the study session.

Outcome measures

Outcome measures
Measure	Virtual Reality Simulation of Neighborhood Disadvantage n=47 Participants Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood representative of disadvantage they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality	Virtual Reality Simulation of Neighborhood Affluence n=45 Participants Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood, representative of affluence they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality
Total Peripheral Resistance (TPR) TPR, Video, Second 15 Minutes (mean)	17.96 mmHg*min/L Standard Deviation 9.21	18.88 mmHg*min/L Standard Deviation 9.29
Total Peripheral Resistance (TPR) TPR, Baseline (mean)	18.82 mmHg*min/L Standard Deviation 8.88	19.29 mmHg*min/L Standard Deviation 12.80
Total Peripheral Resistance (TPR) TPR, VR neighborhood (mean)	19.62 mmHg*min/L Standard Deviation 8.28	18.05 mmHg*min/L Standard Deviation 9.19
Total Peripheral Resistance (TPR) TPR, Questionnaires (mean)	18.29 mmHg*min/L Standard Deviation 7.55	18.04 mmHg*min/L Standard Deviation 10.04
Total Peripheral Resistance (TPR) TPR, Video, First 15 Minutes (mean)	19.07 mmHg*min/L Standard Deviation 9.65	18.83 mmHg*min/L Standard Deviation 9.79

PRIMARY outcome

Population: Two participants (one from each arm) were excluded from analyses due to major technical problems / glitches in virtual reality that lead to invalid data. One participant had technical problems led to data not being recorded, and four had minimal or low quality signal recorded across data collection.

Pre-ejection period (PEP) is a measure of sympathetic nervous system activation. Higher values indicate greater sympathetic activation. Derived from impedance cardiography (Q-point in ECG to B-point in impedance cardiography), signals are measured and and then summarized across epochs in the study session.

Outcome measures

Outcome measures
Measure	Virtual Reality Simulation of Neighborhood Disadvantage n=47 Participants Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood representative of disadvantage they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality	Virtual Reality Simulation of Neighborhood Affluence n=45 Participants Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood, representative of affluence they were assigned to. Then they will complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality
Pre-ejection Period (PEP) PEP, Baseline (mean)	114.69 ms Standard Deviation 7.43	117.92 ms Standard Deviation 7.64
Pre-ejection Period (PEP) PEP, VR neighborhood (mean)	112.49 ms Standard Deviation 6.42	113.84 ms Standard Deviation 8.64
Pre-ejection Period (PEP) PEP, Video, First 15 Minutes (mean)	114.29 ms Standard Deviation 6.94	115.58 ms Standard Deviation 7.43
Pre-ejection Period (PEP) PEP, Video, Second 15 Minutes (mean)	113.28 ms Standard Deviation 7.04	114.75 ms Standard Deviation 8.18
Pre-ejection Period (PEP) PEP, Questionnaires (mean)	112.97 ms Standard Deviation 6.68	114.60 ms Standard Deviation 8.68

Adverse Events

Virtual Reality Simulation of Neighborhood Disadvantage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Virtual Reality Simulation of Neighborhood Affluence

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel A. Hackman, Ph.D.

University of Southern California

Phone: (213) 821-3112

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place