Trial Outcomes & Findings for Virtual Reality Compared to Screen Based Engagement on Mood (NCT NCT05249582)

Last Updated: 2024-09-19

Results Overview

There are twenty total items of the Positive and Negative Affect Schedule. The Positive and Negative Affect Schedule has two subscales, negative affect and positive affect, that consist of 10 items each on a 5-point likert scale from 1 (very slightly or not at all) to 5 (extremely). The PANAS has different time instructions based on when the researcher would like to measure affect and the moment instruction was used. The minimum value for each subscale is 1 and the maximum for each subscale is 5. Each subscale is calculated from an average of 10 items that compose of the subscale. Higher scores indicate more endorsement of positive affect or negative affect depending on the subscale endorsed. Individuals were provided the Positive and Negative Affect Schedule at baseline and after completion 2 minute of mood induction.

Recruitment status

COMPLETED

Study phase

Target enrollment

64 participants

Primary outcome timeframe

Baseline to after 2 minutes of mood induction

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Virtual Reality Condition Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset	Control Condition Participants will be mimicking hand movements displayed on a television screen. Television Condition: Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game
Overall Study STARTED	33	31
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Virtual Reality Condition Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset	Control Condition Participants will be mimicking hand movements displayed on a television screen. Television Condition: Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game
Overall Study Technical Problems with virtual reality prevented completion	2	0
Overall Study Internet connectivity prevented completion of the condition	0	1
Overall Study Declined to use virtual reality headset	1	0

Baseline Characteristics

Virtual Reality Compared to Screen Based Engagement on Mood

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Reality Condition n=30 Participants Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset	Control Condition n=30 Participants Participants will be mimicking hand movements displayed on a television screen. Television Condition: Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game	Total n=60 Participants Total of all reporting groups
Age, Continuous	37.17 Years STANDARD_DEVIATION 13.42 • n=5 Participants	34.87 Years STANDARD_DEVIATION 14.52 • n=7 Participants	36.02 Years STANDARD_DEVIATION 13.92 • n=5 Participants
Sex/Gender, Customized Male	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Sex/Gender, Customized Female	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Sex/Gender, Customized Not Specified	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Middle Eastern or North African	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Some Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized No Answer	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Positive and Negative Affect Schedule Positive Affect subscale	33.83 units on scale STANDARD_DEVIATION 8.55 • n=5 Participants	30.07 units on scale STANDARD_DEVIATION 8.41 • n=7 Participants	31.95 units on scale STANDARD_DEVIATION 8.62 • n=5 Participants
Positive and Negative Affect Schedule Negative Affect subscale	14.07 units on scale STANDARD_DEVIATION 5.71 • n=5 Participants	12.8 units on scale STANDARD_DEVIATION 3.84 • n=7 Participants	13.43 units on scale STANDARD_DEVIATION 4.87 • n=5 Participants
Mood Sliding Scale	7.71 units on scale STANDARD_DEVIATION 1.54 • n=5 Participants	7.6 units on scale STANDARD_DEVIATION 1.92 • n=7 Participants	7.65 units on scale STANDARD_DEVIATION 1.37 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to after 2 minutes of mood induction

Population: Participants in the study

Outcome measures

Outcome measures
Measure	Virtual Reality Condition n=30 Participants Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset	Control Condition n=30 Participants Participants will be mimicking hand movements displayed on a television screen. Television Condition: Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game
Change in Positive Affect and Negative Affect From Baseline to After a 2 Minute Mood Induction Positive Affect Change from Baseline to 2 minute mood induction	3.7 units on a scale Standard Deviation 7.22	4.63 units on a scale Standard Deviation 6
Change in Positive Affect and Negative Affect From Baseline to After a 2 Minute Mood Induction Negative Affect Change from Baseline to 2 minute mood induction	1.97 units on a scale Standard Deviation 3.24	1.56 units on a scale Standard Deviation 5.59

PRIMARY outcome

Timeframe: Mood induction to after an average of 15 minutes of virtual reality or control condition

There are twenty total items of the Positive and Negative Affect Schedule. The Positive and Negative Affect Schedule has two subscales, negative affect and positive affect, that consist of 10 items each on a 5-point likert scale from 1 (very slightly or not at all) to 5 (extremely). The PANAS has different time instructions based on when the researcher would like to measure affect and the moment instruction was used. The minimum total value for both positive and negative affect subscales is 10 and the maximum total value for each subscale is 50. Higher scores indicate more endorsement of positive affect or negative affect depending on the subscale endorsed. Participants were measured after mood induction and after completion of the virtual reality or control condition. A change in score was calculated by subtracting the total value of the negative subscale before and after the time point and subtracting the total value of the positive subscale before and after the time point.

Outcome measures

Outcome measures
Measure	Virtual Reality Condition n=30 Participants Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset	Control Condition n=30 Participants Participants will be mimicking hand movements displayed on a television screen. Television Condition: Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game
Change in Positive Affect and Negative Affect From Mood Induction to After Condition Completion Negative Affect Subscale Change from Mood Induction to After Condition Completion	.21 units on a scale Standard Deviation 5.75	2.92 units on a scale Standard Deviation 3.8
Change in Positive Affect and Negative Affect From Mood Induction to After Condition Completion Positive Affect Subscale Change from Mood Induction to After Condition	8.68 units on a scale Standard Deviation 10.7	5.5 units on a scale Standard Deviation 7.3

SECONDARY outcome

Timeframe: One measure after approximately 30 minutes after start of study

The Temple Presence Inventory measures the amount of presence across different technologies such as virtual reality. The Temple Presence Inventory has eight subscales that measure the following dimensions: spatial presence, social presence with actor in medium, passive social presence, active social presence, presence as engagement, presence as social richness, presence as social realism, and presence as perceptual realism. Only spatial presence and presence as engagement was utilized in the study to determine presence as no social interaction was utilized in the study. Each item is rated on a 7-point scale from 1 (not at all) to 7 (very much) with higher mean subscale scores reflecting higher association with the specific presence factor. The minimum value for each subscale was 1 and the maximum value was 7. Each participant was only measured once approximately 30 minutes after the start of study after they completed rather the virtual reality condition or control condition.

Outcome measures

Outcome measures
Measure	Virtual Reality Condition n=30 Participants Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset	Control Condition n=30 Participants Participants will be mimicking hand movements displayed on a television screen. Television Condition: Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game
Temple Presence Inventory Score Total Spatial Presence Subscale	5.71 units on a scale Standard Deviation .85	3.63 units on a scale Standard Deviation 1.64
Temple Presence Inventory Score Total Presence as Engagement subscale	6.25 units on a scale Standard Deviation .76	3.89 units on a scale Standard Deviation 1.47

SECONDARY outcome

Timeframe: Approximately 5 minutes after start of the study

The Patient Health Questionnaire-8 is an 8-item self-report measure used to screen for major depressive episodes and the severity of depressive symptoms. Each item is rated on a 4-point scale from 0 (not at all) to 3 (nearly every day) with higher mean scores reflecting more depressive symptoms. Individuals were measured once at the beginning of the study. The minimum value for the PHQ-8 was 0 and maximum was 24.

Outcome measures

Outcome measures
Measure	Virtual Reality Condition n=30 Participants Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset	Control Condition n=30 Participants Participants will be mimicking hand movements displayed on a television screen. Television Condition: Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game
Patient Health Questionnaire Depression Scale Total	3.21 units on a scale Standard Deviation 3.29	4.07 units on a scale Standard Deviation 3.82

SECONDARY outcome

Timeframe: Once approximately 30 minutes after start of study

The Affinity for Technology Interaction Scale is a 9-item measure used to assess an individual's level of engagement with technology. Each item is rated on a 6-point Likert scale from 1 (completely disagree) to 6 (completely agree). Items 3, 6, and 8 are reverse coded and a mean score is calculated with higher scores reflecting an individual having more independence and utilization of technology. Each participant completed the measure once after completion of the virtual reality condition or control condition. The minimum score was 1 and maximum was 6.

Outcome measures

Outcome measures
Measure	Virtual Reality Condition n=30 Participants Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset	Control Condition n=30 Participants Participants will be mimicking hand movements displayed on a television screen. Television Condition: Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game
Affinity for Technology Interaction Scale Total Score	4 units on a scale Standard Deviation .72	3.86 units on a scale Standard Deviation 1.09

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 2 minute mood induction.

Population: Participants in study

Participant subjective mood rating was measured with a 10-point Likert visual analogue scale from not smiling (1) to smiling (10). Higher scores indicate more positive mood and lower scores indicate more negative mood. Minimum score was 1 and maximum was 10. A change in score was calculated by comparing the baseline score to after the 2 minute mood induction.

Outcome measures

Outcome measures
Measure	Virtual Reality Condition n=30 Participants Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset	Control Condition n=30 Participants Participants will be mimicking hand movements displayed on a television screen. Television Condition: Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game
Change in Mood Rating Scale From Baseline to After 2 Minute Mood Induction	1.21 units on a scale Standard Deviation 1.34	1.2 units on a scale Standard Deviation 1.06

OTHER_PRE_SPECIFIED outcome

Timeframe: Change in affect after average of 15 minutes of virtual reality or control condition

Population: Participants in study

Participant subjective mood rating will be measured with a 10-point Likert visual analogue scale from not smiling to smiling.

Outcome measures

Outcome measures
Measure	Virtual Reality Condition n=30 Participants Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset	Control Condition n=30 Participants Participants will be mimicking hand movements displayed on a television screen. Television Condition: Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game
Change in Mood Rating Scale	1.76 units on a scale Standard Deviation 1.71	1.3 units on a scale Standard Deviation 1.18

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 30 minutes after start of study

Participants will be asked three questions on a 7-point Likert scale from 1 (not at all) to 7 (very much) about the difficulty, enjoyment, and helpfulness of the virtual reality or control condition technology. Higher scores indicate more endorsement of difficulty, enjoyment, or helpfulness. Minimum score was 1 and maximum score was 7. Individuals were given the measure once at the end of the study and reported score was utilized with no additional calculations.

Outcome measures

Outcome measures
Measure	Virtual Reality Condition n=30 Participants Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset	Control Condition n=30 Participants Participants will be mimicking hand movements displayed on a television screen. Television Condition: Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game
Media Feedback Questions Scores Difficulty Question	4.7 units on a scale Standard Deviation 1.6	3.31 units on a scale Standard Deviation 1.52
Media Feedback Questions Scores Enjoyment Question	5.97 units on a scale Standard Deviation 1.45	3.79 units on a scale Standard Deviation 1.7
Media Feedback Questions Scores Helpfulness Question	5.4 units on a scale Standard Deviation 1.55	3.6 units on a scale Standard Deviation 1.63

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 30 minutes after start of study

The Net Promoter Score is a single question used to examine an individual's satisfaction with the company or service. Participants answered the question on an 11-point scale from 0 (not likely at all) to 10 (extremely likely), "how likely would you recommend the activity you did to a friend or colleague?". Participants completed the measure at the end of the study with a minimum score of 0 and maximum score of 10. Higher scores represent more endorsement and satisfaction with their experience. Individuals score was reported with no additional calculations.

Outcome measures

Outcome measures
Measure	Virtual Reality Condition n=30 Participants Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset	Control Condition n=30 Participants Participants will be mimicking hand movements displayed on a television screen. Television Condition: Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game
Net Promoter Score	8.47 units on a scale Standard Deviation 2.2	5.49 units on a scale Standard Deviation 3.05

Adverse Events

Virtual Reality Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Condition

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

Erick Kim

Palo Alto University

Phone: (510) 457-1584

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place