Trial Outcomes & Findings for Role of Virtual Reality (VR) in Patients With Sickle Cell Disease (SCD) (NCT NCT03387033)

Last Updated: 2021-03-01

Results Overview

Patient satisfaction with session measured on a Likert-type scale with the following options: Very unsatisfied, unsatisfied, not unsatisfied or satisfied, satisfied, very satisfied. Participants were also asked if they agree with the statement that the 'VR device was helpful'.

Recruitment status

TERMINATED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Day 1

Results posted on

2021-03-01

Participant Flow

A total of 20 patients were enrolled into the study from the outpatient sickle cell clinic (15%), inpatient unit (15%) and sickle cell day hospital (70%).

Participant milestones

Participant milestones
Measure	VR Intervention Session The patients will give a pain score as well as fill out GAD-7 and PHQ-9 scores initially. The VR intervention session consists of relaxation narration WITH Virtual Reality session for 20 minutes while wearing the VR device. They will then be again asked to give a pain score and fill out GAD-7, PHQ-9, and PGIC. Relaxation response and virtual reality (VR) session: A 10-minute relaxation response (mindfulness and deep breathing) followed by 10-minute immersive VR session.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Role of Virtual Reality (VR) in Patients With Sickle Cell Disease (SCD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VR Intervention Session n=20 Participants The patients will give a pain score as well as fill out GAD-7 and PHQ-9 scores initially. The VR intervention session consists of relaxation narration WITH Virtual Reality session for 20 minutes while wearing the VR device. They will then be again asked to give a pain score and fill out GAD-7, PHQ-9, and PGIC. Relaxation response and virtual reality (VR) session: A 10-minute relaxation response (mindfulness and deep breathing) followed by 10-minute immersive VR session.
Age, Continuous	28.5 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants
Sickle Cell Disease (SCD) Type SS	9 Participants n=5 Participants
Sickle Cell Disease (SCD) Type SC	7 Participants n=5 Participants
Sickle Cell Disease (SCD) Type Other	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Data not collected on 8 participants.

Outcome measures

Outcome measures
Measure	VR Intervention Session n=12 Participants The patients will give a pain score as well as fill out GAD-7 and PHQ-9 scores initially. The VR intervention session consists of relaxation narration WITH Virtual Reality session for 20 minutes while wearing the VR device. They will then be again asked to give a pain score and fill out GAD-7, PHQ-9, and PGIC. Relaxation response and virtual reality (VR) session: A 10-minute relaxation response (mindfulness and deep breathing) followed by 10-minute immersive VR session.
Feasibility of VR Session as Measured by Patient Satisfaction Survey. 'Satisfied' to 'very satisfied'	9 Participants
Feasibility of VR Session as Measured by Patient Satisfaction Survey. Agree with the statement that the 'VR device was helpful'	11 Participants

SECONDARY outcome

Timeframe: Baseline, up to 30 mins

Population: Three participants did not have both a before and an after score.

Change in pain score as measured by visual analog pain score (0-10), where 0 = no pain and 10 = worst pain.

Outcome measures

Outcome measures
Measure	VR Intervention Session n=17 Participants The patients will give a pain score as well as fill out GAD-7 and PHQ-9 scores initially. The VR intervention session consists of relaxation narration WITH Virtual Reality session for 20 minutes while wearing the VR device. They will then be again asked to give a pain score and fill out GAD-7, PHQ-9, and PGIC. Relaxation response and virtual reality (VR) session: A 10-minute relaxation response (mindfulness and deep breathing) followed by 10-minute immersive VR session.
Change in Pain Score	-0.88 score on a scale Standard Deviation 0.53

SECONDARY outcome

Timeframe: Baseline, up to 30 mins

GAD-7 total score for the seven items ranges from 0 to 21, calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." A total score of 0-4 = minimal anxiety, 5-9 = mild anxiety, 10-14 = moderate anxiety, 15-21 = severe anxiety. A negative score change indicates a decrease in anxiety symptoms and a positive score change indicates an increase in anxiety symptoms.

Outcome measures

Outcome measures
Measure	VR Intervention Session n=20 Participants The patients will give a pain score as well as fill out GAD-7 and PHQ-9 scores initially. The VR intervention session consists of relaxation narration WITH Virtual Reality session for 20 minutes while wearing the VR device. They will then be again asked to give a pain score and fill out GAD-7, PHQ-9, and PGIC. Relaxation response and virtual reality (VR) session: A 10-minute relaxation response (mindfulness and deep breathing) followed by 10-minute immersive VR session.
Change in Anxiety-related Symptoms as Measured by Generalized Anxiety Disorder-7 (GAD-7) Score	-1.80 score on a scale Standard Deviation 1.62

SECONDARY outcome

Timeframe: Baseline, up to 30 mins

The PHQ-9 has a total range of 0-27, where 0 = No depression, 1-4 = Minimal depression, 5-9 = Mild depression, 10-14 = Moderate depression, 15-19 = Moderately severe depression, 20-27 = Severe depression. A negative score change indicates a decrease in depressive symptoms and a positive score change indicates an increase in depressive symptoms.

Outcome measures

Outcome measures
Measure	VR Intervention Session n=20 Participants The patients will give a pain score as well as fill out GAD-7 and PHQ-9 scores initially. The VR intervention session consists of relaxation narration WITH Virtual Reality session for 20 minutes while wearing the VR device. They will then be again asked to give a pain score and fill out GAD-7, PHQ-9, and PGIC. Relaxation response and virtual reality (VR) session: A 10-minute relaxation response (mindfulness and deep breathing) followed by 10-minute immersive VR session.
Change in Depressive Symptoms as Measured by Patient Health Questionnaire-9 (PHQ-9) Score	-1.85 score on a scale Standard Deviation 1.57

Adverse Events

VR Intervention Session

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

Nirmish Shah, MD

Duke University

Phone: 919-668-5178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place