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

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ClinicalTrials.gov Identifier: NCT03387033
Recruitment Status : Terminated (enrollment closed due to lack of funding)
First Posted : December 29, 2017
Results First Posted : March 1, 2021
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Sickle Cell Disease
Virtual Reality
Anxiety
Depression
Cancer
Intervention Device: Relaxation response and virtual reality (VR) session
Enrollment 20
Recruitment Details 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%).
Pre-assignment Details  
Arm/Group Title VR Intervention Session
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title VR Intervention Session
Hide Arm/Group Description

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 Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
28.5
(19 to 57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
13
  65.0%
Male
7
  35.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
20
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
20
 100.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
Sickle Cell Disease (SCD) Type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
SS
9
  45.0%
SC
7
  35.0%
Other
4
  20.0%
[1]
Measure Description: Hemoglobin SS disease is the most common type of sickle cell disease and the most severe form of SCD. Hemoglobin SC disease is the second most common type of sickle cell disease. Symptoms are similar to individuals with Hb SS, but the anemia is less severe.
1.Primary Outcome
Title Feasibility of VR Session as Measured by Patient Satisfaction Survey.
Hide Description 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'.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected on 8 participants.
Arm/Group Title VR Intervention Session
Hide Arm/Group Description:

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 Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
'Satisfied' to 'very satisfied'
9
  75.0%
Agree with the statement that the 'VR device was helpful'
11
  91.7%
2.Secondary Outcome
Title Change in Pain Score
Hide Description Change in pain score as measured by visual analog pain score (0-10), where 0 = no pain and 10 = worst pain.
Time Frame Baseline, up to 30 mins
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants did not have both a before and an after score.
Arm/Group Title VR Intervention Session
Hide Arm/Group Description:

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 Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.88  (0.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VR Intervention Session
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.005
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
3.Secondary Outcome
Title Change in Anxiety-related Symptoms as Measured by Generalized Anxiety Disorder-7 (GAD-7) Score
Hide Description 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.
Time Frame Baseline, up to 30 mins
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VR Intervention Session
Hide Arm/Group Description:

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 Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.80  (1.62)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VR Intervention Session
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
4.Secondary Outcome
Title Change in Depressive Symptoms as Measured by Patient Health Questionnaire-9 (PHQ-9) Score
Hide Description 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.
Time Frame Baseline, up to 30 mins
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VR Intervention Session
Hide Arm/Group Description:

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 Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.85  (1.57)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VR Intervention Session
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Time Frame During virtual reality (VR) session, up to 30 minutes
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VR Intervention Session
Hide Arm/Group Description

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.

All-Cause Mortality
VR Intervention Session
Affected / at Risk (%)
Total   0/20 (0.00%) 
Hide Serious Adverse Events
VR Intervention Session
Affected / at Risk (%)
Total   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VR Intervention Session
Affected / at Risk (%)
Total   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nirmish Shah, MD
Organization: Duke University
Phone: 919-668-5178
EMail: nirmish.shah@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03387033    
Other Study ID Numbers: Pro00082388
First Submitted: June 14, 2017
First Posted: December 29, 2017
Results First Submitted: February 9, 2021
Results First Posted: March 1, 2021
Last Update Posted: March 1, 2021