Trial Outcomes & Findings for Virtual Reality Distraction for Reduction (NCT NCT04416555)

Results Overview

The primary outcome was post-intervention pain score, adjusted for the corresponding pre-intervention pain score. Pain scores were measured by the Numerical Rating Scale which ranges from 0 (lowest pain) to 10 (highest pain) We targeted 3 interventions per day for each patient, and thus, correspondingly 3 pre-post pain measurements per day. The reported value is the least squares mean calculated using a mixed model for repeated measures.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

113 participants

Primary outcome timeframe

From the end of surgery until 48 hours after surgery or discharge, whichever comes first

Results posted on

2023-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	Virtual Reality (VR) Headset With the Real VR Program Experience The study group will receive the VR headset and the real VR program experience.	VR Headset Using Sham 2D Programs The study groups will receive VR headset and sham, two-dimensional programs
Overall Study STARTED	55	58
Overall Study COMPLETED	55	55
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Virtual Reality (VR) Headset With the Real VR Program Experience The study group will receive the VR headset and the real VR program experience.	VR Headset Using Sham 2D Programs The study groups will receive VR headset and sham, two-dimensional programs
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

Virtual Reality Distraction for Reduction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Reality (VR) Headset With the Real VR Program Experience n=55 Participants The study group will receive the VR headset and the real VR program experience.	VR Headset Using Sham 2D Programs n=55 Participants The study groups will receive VR headset and sham, two-dimensional programs	Total n=110 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 10 • n=93 Participants	63 years STANDARD_DEVIATION 9 • n=4 Participants	64 years STANDARD_DEVIATION 9.8 • n=27 Participants
Sex: Female, Male Female	29 Participants n=93 Participants	26 Participants n=4 Participants	55 Participants n=27 Participants
Sex: Female, Male Male	26 Participants n=93 Participants	29 Participants n=4 Participants	55 Participants n=27 Participants
Race/Ethnicity, Customized White	49 Participants n=93 Participants	49 Participants n=4 Participants	98 Participants n=27 Participants
Race/Ethnicity, Customized Black	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Race/Ethnicity, Customized Multiracial	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Unavailable/Declined	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
BMI	31 kg/m^2 STANDARD_DEVIATION 6 • n=93 Participants	32 kg/m^2 STANDARD_DEVIATION 7 • n=4 Participants	31.5 kg/m^2 STANDARD_DEVIATION 6.3 • n=27 Participants

PRIMARY outcome

Timeframe: From the end of surgery until 48 hours after surgery or discharge, whichever comes first

Population: 113 patients were enrolled. 3 withdrew and requested to have their data excluded. 4 patients had missing data for the primary outcome.

The primary outcome was post-intervention pain score, adjusted for the corresponding pre-intervention pain score. Pain scores were measured by the Numerical Rating Scale which ranges from 0 (lowest pain) to 10 (highest pain) We targeted 3 interventions per day for each patient, and thus, correspondingly 3 pre-post pain measurements per day. The reported value is the least squares mean calculated using a mixed model for repeated measures.

Outcome measures

Outcome measures
Measure	Virtual Reality (VR) Headset With the Real VR Program Experience n=52 Participants The study group will receive the VR headset and the real VR program experience.	VR Headset Using Sham 2D Programs n=54 Participants The study groups will receive VR headset and sham, two-dimensional programs
Pain Scores (Numerical Rating Scale)	3.4 score on a scale Standard Error 0.3	3.5 score on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: End of surgery to 72 hours after surgery.

Population: 113 patients were enrolled. 3 patients withdrew and requested to have their data excluded. And 3 other patients had missing data for this outcome.

The investigators measured total opioid consumption converted to morphine milligram equivalents (MME).

Outcome measures

Outcome measures
Measure	Virtual Reality (VR) Headset With the Real VR Program Experience n=52 Participants The study group will receive the VR headset and the real VR program experience.	VR Headset Using Sham 2D Programs n=55 Participants The study groups will receive VR headset and sham, two-dimensional programs
Total Opioid Consumption	6.8 morphine milligrams equivalent Standard Error 3.4	5.7 morphine milligrams equivalent Standard Error 2.6

SECONDARY outcome

Timeframe: End of surgery to 48 hours after surgery

Population: 113 patients were enrolled. 3 patients withdrew and requested to have their data excluded. And 5 other patients had missing data for this outcome.

Pain scores collected by nursing staff every 4 hours during the first 48 hours after surgery. Pain scores were measured by the Numerical Rating Scale which ranges from 0 (lowest pain) to 10 (highest pain). The reported value is the least squares mean calculated using a mixed model for repeated measures.

Outcome measures

Outcome measures
Measure	Virtual Reality (VR) Headset With the Real VR Program Experience n=52 Participants The study group will receive the VR headset and the real VR program experience.	VR Headset Using Sham 2D Programs n=53 Participants The study groups will receive VR headset and sham, two-dimensional programs
Time Weighted Average Pain Score	4.3 units on a scale Standard Error 0.6	4.4 units on a scale Standard Error 0.6

SECONDARY outcome

Timeframe: Once between last intervention time and hospital discharge (up to 8 days after end of surgery)

Population: 113 patients were enrolled. 3 patients withdrew and requested to have their data excluded. Five patients had missing data for this outcome due to being lost to follow up.

Patient's perception of video system usability was assessed using a validated questionnaire (System Usability Scale). The System Usability Scale is scored from 0 to 100 and higher scores are related with devices that are easier to use.

Outcome measures

Outcome measures
Measure	Virtual Reality (VR) Headset With the Real VR Program Experience n=52 Participants The study group will receive the VR headset and the real VR program experience.	VR Headset Using Sham 2D Programs n=53 Participants The study groups will receive VR headset and sham, two-dimensional programs
Perception of Video System Usability	75 score on a scale Interval 70.0 to 83.0	70 score on a scale Interval 65.0 to 83.0

SECONDARY outcome

Timeframe: One week (7 days) after hospital discharge

Population: 113 patients were enrolled. 3 patients withdrew and requested to have their data excluded. Nine patients had missing data for this outcome due to being lost to follow up.

Pain Outcomes Questionnaire Short Form, which evaluates five domains (pain, mobility, activities of daily living, vitality, negative affect and fear). The Pain Outcomes Questionnaire Short Form is scored from 0 to 190 and higher scores are related with worst pain outcomes.

Outcome measures

Outcome measures
Measure	Virtual Reality (VR) Headset With the Real VR Program Experience n=49 Participants The study group will receive the VR headset and the real VR program experience.	VR Headset Using Sham 2D Programs n=52 Participants The study groups will receive VR headset and sham, two-dimensional programs
Post Discharge Analgesia.	67 score on a scale Interval 47.0 to 93.0	58 score on a scale Interval 40.0 to 87.0

Adverse Events

Virtual Reality (VR) Headset With the Real VR Program Experience

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

VR Headset Using Sham 2D Programs

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

Dr. Sabry Ayad

Cleveland Clinic

Phone: 216.476.7052

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place