Trial Outcomes & Findings for Virtual Reality Guided Imagery for Chronic Pain (NCT NCT04849897)
NCT ID: NCT04849897
Last Updated: 2024-08-21
Results Overview
Participant log tracks number of recruited participants who are ineligible to participate and/or decline to enroll
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Baseline
Results posted on
2024-08-21
Participant Flow
96 applicants were recruited, 81 met inclusion criteria. 36 participants were enrolled.
Participant milestones
| Measure |
Virtual Reality Guided Imagery (VR-GI)
VR headset for guided imagery with audiovisual computer-generated VR content to accompany the GI narration. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the VR-GI experience.
|
Audio Only Guided Imagery (AO-GI)
Listen to narrative scripts based on traditional GI audio recordings. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the GI experience.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
12
|
|
Overall Study
COMPLETED
|
21
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Virtual Reality Guided Imagery for Chronic Pain
Baseline characteristics by cohort
| Measure |
Audio Only Guided Imagery (AO-GI)
n=12 Participants
Listen to narrative scripts based on traditional GI audio recordings. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the GI experience.
|
Virtual Reality Guided Imagery (VR-GI)
n=24 Participants
VR headset for guided imagery with audiovisual computer-generated VR content to accompany the GI narration. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the VR-GI experience.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
age greater than 18
|
12 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineParticipant log tracks number of recruited participants who are ineligible to participate and/or decline to enroll
Outcome measures
| Measure |
Total Recruited
n=96 Participants
Recruited participants who are ineligible to participate and/or decline to enroll
|
Audio Only Guided Imagery (AO-GI)
Listen to narrative scripts based on traditional GI audio recordings. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the GI experience.
|
|---|---|---|
|
Number of Participants Who Are Recruited But Not Enrolled as Documented in Participant Log
|
60 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline to 2 week follow upParticipant log tracks the number of enrolled participants who discontinue intervention, are lost to follow-up and/or experience adverse events.
Outcome measures
| Measure |
Total Recruited
n=24 Participants
Recruited participants who are ineligible to participate and/or decline to enroll
|
Audio Only Guided Imagery (AO-GI)
n=12 Participants
Listen to narrative scripts based on traditional GI audio recordings. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the GI experience.
|
|---|---|---|
|
Number of Enrolled Participants Who do Not Complete the Study as Documented in Log
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 week follow upPopulation: For the VR-Gi group, 23 participants were analyzed as one participant did not receive allocated intervention.
Spread sheet documenting proportion of at-home daily GI practice completed over 2-week intervention
Outcome measures
| Measure |
Total Recruited
n=23 Participants
Recruited participants who are ineligible to participate and/or decline to enroll
|
Audio Only Guided Imagery (AO-GI)
n=12 Participants
Listen to narrative scripts based on traditional GI audio recordings. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the GI experience.
|
|---|---|---|
|
Number of Practice Sessions Completed by Participants as Documented in Spread Sheet
|
10.8 Daily ratings completed
Standard Deviation 3.58
|
11.4 Daily ratings completed
Standard Deviation 4.27
|
PRIMARY outcome
Timeframe: Baseline to 2 week follow upPopulation: For the VR-GI group, 23 participants were analyzed as one participant did not receive allocated intervention. For the AO-GI group, 11 participants were analyzed as one participant did not complete post-intervention questionnaires.
Numeric Rating Scale of self-reported highest, lowest, and average pain scores (0-10) over the last 7 days. Higher scores indicate worse pain outcomes.
Outcome measures
| Measure |
Total Recruited
n=23 Participants
Recruited participants who are ineligible to participate and/or decline to enroll
|
Audio Only Guided Imagery (AO-GI)
n=11 Participants
Listen to narrative scripts based on traditional GI audio recordings. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the GI experience.
|
|---|---|---|
|
Pain Assessed by Pain Numeric Rating Scale
Highest Score Baseline
|
8.42 units on a scale
Standard Deviation 0.83
|
7.75 units on a scale
Standard Deviation 1.36
|
|
Pain Assessed by Pain Numeric Rating Scale
Highest Score Follow-up
|
7.86 units on a scale
Standard Deviation 1.01
|
7.4 units on a scale
Standard Deviation 0.97
|
|
Pain Assessed by Pain Numeric Rating Scale
Change in Lowest Score Follow up Baseline
|
0.381 units on a scale
Standard Deviation 1.36
|
0.091 units on a scale
Standard Deviation 1.04
|
|
Pain Assessed by Pain Numeric Rating Scale
Lowest Score Baseline
|
4 units on a scale
Standard Deviation 1.82
|
3.92 units on a scale
Standard Deviation 1.51
|
|
Pain Assessed by Pain Numeric Rating Scale
Lowest Score Follow up
|
3.71 units on a scale
Standard Deviation 1.95
|
3.64 units on a scale
Standard Deviation 1.63
|
|
Pain Assessed by Pain Numeric Rating Scale
Change in Highest Score Follow-up-Baseline
|
0.619 units on a scale
Standard Deviation .973
|
0.100 units on a scale
Standard Deviation 1.37
|
|
Pain Assessed by Pain Numeric Rating Scale
Change in Average Score Follow-up-baseline
|
0.524 units on a scale
Standard Deviation 1.08
|
0.182 units on a scale
Standard Deviation 1.08
|
|
Pain Assessed by Pain Numeric Rating Scale
Average Score Baseline
|
6.08 units on a scale
Standard Deviation 1.18
|
5.75 units on a scale
Standard Deviation 1.42
|
|
Pain Assessed by Pain Numeric Rating Scale
Average Score Follow-up
|
5.62 units on a scale
Standard Deviation 1.5
|
5.46 units on a scale
Standard Deviation 1.44
|
PRIMARY outcome
Timeframe: Baseline to 2 week follow upPopulation: For the VR-GI group, 3 participants were analyzed as others did not have opioid usage. For the AO-GI group, 4 participants were analyzed as others did not have opioid usage.
Log with list of medications taken, dosages and frequency of use. Lower frequency indicates better outcomes.
Outcome measures
| Measure |
Total Recruited
n=3 Participants
Recruited participants who are ineligible to participate and/or decline to enroll
|
Audio Only Guided Imagery (AO-GI)
n=4 Participants
Listen to narrative scripts based on traditional GI audio recordings. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the GI experience.
|
|---|---|---|
|
Opioid Medication Usage Assessed by Frequency of Use Log
|
0 Count of Participants with Reduced Opioi
|
1 Count of Participants with Reduced Opioi
|
PRIMARY outcome
Timeframe: Baseline to 2 week follow upLog with list of non-opioid pain mediction taken, dosages and frequency of use. Lower frequency of use indicates better outcomes
Outcome measures
| Measure |
Total Recruited
n=23 Participants
Recruited participants who are ineligible to participate and/or decline to enroll
|
Audio Only Guided Imagery (AO-GI)
n=11 Participants
Listen to narrative scripts based on traditional GI audio recordings. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the GI experience.
|
|---|---|---|
|
Non-opioid Pain Medication Usage Assessed by Frequency of Use Log
|
6 Pt. count reduced non-opoid pain med use
|
3 Pt. count reduced non-opoid pain med use
|
SECONDARY outcome
Timeframe: Baseline to 2 week follow upPopulation: For the VR-GI group, 23 participants were analyzed as one participant did not receive allocated intervention. For the AO-GI group, 11 participants were analyzed as one participant did not complete post-intervention questionnaires.
Generalized Anxiety Disorder Assessment is calculated by assigning scores of 1,2,3 and 4, to the response categories of Not at all sure, Several Days,Over half the days, Nearly every day , respectively. Total score for the two ranges from 0-6 with higher number indicating worse anxiety outcome.
Outcome measures
| Measure |
Total Recruited
n=23 Participants
Recruited participants who are ineligible to participate and/or decline to enroll
|
Audio Only Guided Imagery (AO-GI)
n=11 Participants
Listen to narrative scripts based on traditional GI audio recordings. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the GI experience.
|
|---|---|---|
|
Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7)
Change in GAD (Follow up-Baseline
|
-1.2 score on GAD-2 scale
Standard Deviation 1.20
|
-.06 score on GAD-2 scale
Standard Deviation 1.17
|
|
Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7)
GAD Baseline
|
1.83 score on GAD-2 scale
Standard Deviation 1.86
|
1.58 score on GAD-2 scale
Standard Deviation 1.68
|
|
Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7)
GAD Follow-up
|
0.9 score on GAD-2 scale
Standard Deviation 1.17
|
1.2 score on GAD-2 scale
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: Baseline to 2 week follow upPopulation: For the VR-GI group, 23 participants were analyzed as one participant did not receive allocated intervention. For the AO-GI group, 11 participants were analyzed as one participant did not complete post-intervention questionnaires.
Patient Health Questionnaire is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of not at all, several days more than half the days, and-nearly every day, respectively. Total score for the two ranges from 0 to 6 with higher number worse depression outcome.
Outcome measures
| Measure |
Total Recruited
n=23 Participants
Recruited participants who are ineligible to participate and/or decline to enroll
|
Audio Only Guided Imagery (AO-GI)
n=11 Participants
Listen to narrative scripts based on traditional GI audio recordings. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the GI experience.
|
|---|---|---|
|
Depression Assessed by the Patient Health Questionnaire PHQ-2
Change in PHQ (Follow up-Baseline)
|
-1.10 score on PHQ-2 scale
Standard Deviation 1.34
|
0 score on PHQ-2 scale
Standard Deviation 0.47
|
|
Depression Assessed by the Patient Health Questionnaire PHQ-2
PHQ Baseline
|
2 score on PHQ-2 scale
Standard Deviation 1.53
|
1.33 score on PHQ-2 scale
Standard Deviation 1.44
|
|
Depression Assessed by the Patient Health Questionnaire PHQ-2
PHQ Follow-up
|
0.86 score on PHQ-2 scale
Standard Deviation 1.39
|
1.3 score on PHQ-2 scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline to 2 week follow upPopulation: For the VR-GI group, 23 participants were analyzed as one participant did not receive allocated intervention. For the AO-GI group, 11 participants were analyzed as one participant did not complete post-intervention questionnaires.
Health-related quality of life assessment Short Form Health Survey 12 has two composite scores (Physical composite score and Mental composite score). Each score has a range of 0 to 100 with higher scores indicating better health outcomes.
Outcome measures
| Measure |
Total Recruited
n=23 Participants
Recruited participants who are ineligible to participate and/or decline to enroll
|
Audio Only Guided Imagery (AO-GI)
n=11 Participants
Listen to narrative scripts based on traditional GI audio recordings. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the GI experience.
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|---|---|---|
|
Short Form Health Survey (SF12v12)
Change in Physical Score (Follow-up- Baseline)
|
7.3 score on SF 12 scale
Standard Deviation 6.42
|
-1.85 score on SF 12 scale
Standard Deviation 6.81
|
|
Short Form Health Survey (SF12v12)
Physical Score Baseline
|
27.0 score on SF 12 scale
Standard Deviation 6.87
|
29.1 score on SF 12 scale
Standard Deviation 4.80
|
|
Short Form Health Survey (SF12v12)
Physical Score Follow up
|
27.9 score on SF 12 scale
Standard Deviation 8.61
|
27.7 score on SF 12 scale
Standard Deviation 7.22
|
|
Short Form Health Survey (SF12v12)
Change in Mental Score (Follow-up - Baseline)
|
6.56 score on SF 12 scale
Standard Deviation 7.25
|
5.65 score on SF 12 scale
Standard Deviation 7.89
|
|
Short Form Health Survey (SF12v12)
Mental Score Baseline
|
43.6 score on SF 12 scale
Standard Deviation 12.3
|
43.5 score on SF 12 scale
Standard Deviation 13.1
|
|
Short Form Health Survey (SF12v12)
Mental Score Follow up
|
50.4 score on SF 12 scale
Standard Deviation 10.2
|
48.6 score on SF 12 scale
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: Baseline to 2 week follow upPopulation: For the VR-GI group, 9 participants out of the 12 participants with a CBP diagnosis were analyzed as 1 participant did not receive intervention, 1 participant discontinued intervention, and 1 did not complete a post-intervention questionnaire. For the AO-GI group, 6 participants were analyzed as they had a CBP diagnosis.
Pain Management assessments for patients with back pain. Oswestry Disability Index For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5 with 50 as a highest score; higher scores indicating a worse disability outcome from back pain. Scale is 0-50.
Outcome measures
| Measure |
Total Recruited
n=9 Participants
Recruited participants who are ineligible to participate and/or decline to enroll
|
Audio Only Guided Imagery (AO-GI)
n=6 Participants
Listen to narrative scripts based on traditional GI audio recordings. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the GI experience.
|
|---|---|---|
|
Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI)
ODI Baseline
|
24.6 score on Oswestry Disability scale
Standard Deviation 5.66
|
25.8 score on Oswestry Disability scale
Standard Deviation 8.98
|
|
Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI)
ODI Follow up
|
20.8 score on Oswestry Disability scale
Standard Deviation 5.65
|
21 score on Oswestry Disability scale
Standard Deviation 9.07
|
|
Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI)
Change in ODI (Follow-up - Baseline)
|
-3.44 score on Oswestry Disability scale
Standard Deviation 3.40
|
-4.83 score on Oswestry Disability scale
Standard Deviation 7.65
|
SECONDARY outcome
Timeframe: Baseline to 2 week follow upPopulation: CSS-17 was unreported due to participants receiving an incomplete CSS-17 questionnaire.
Pain management assessments for patients with CRPS. Complex Regional Pain Syndrome (CRPS) Severity Score (CSS-17) 0 absence of symptoms, 1 presence of symptoms, 0-8, higher score indicate worse symptom outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 2 week follow upPopulation: For the VR-GI group, 23 participants were analyzed as one participant did not receive allocated intervention. For the AO-GI group, 11 participants were analyzed as one participant did not complete post-intervention questionnaires.
Rating of current pain intensity from 0-10 with higher number indicated worse pain outcomes
Outcome measures
| Measure |
Total Recruited
n=23 Participants
Recruited participants who are ineligible to participate and/or decline to enroll
|
Audio Only Guided Imagery (AO-GI)
n=12 Participants
Listen to narrative scripts based on traditional GI audio recordings. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the GI experience.
|
|---|---|---|
|
Daily Pain Numerical Rating Scale
Change in Pain Score (Follow-up - Baseline)
|
-0.906 difference score on pain scale
Standard Deviation 0.851
|
-.757 difference score on pain scale
Standard Deviation 0.489
|
|
Daily Pain Numerical Rating Scale
Pre Pain Score
|
5.75 difference score on pain scale
Standard Deviation 1.5
|
5.49 difference score on pain scale
Standard Deviation 1.41
|
|
Daily Pain Numerical Rating Scale
Post pain Score
|
4.82 difference score on pain scale
Standard Deviation 1.48
|
4.8 difference score on pain scale
Standard Deviation 1.47
|
Adverse Events
Virtual Reality Guided Imagery (VR-GI)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Audio Only Guided Imagery (AO-GI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Virtual Reality Guided Imagery (VR-GI)
n=23 participants at risk
VR headset for guided imagery with audiovisual computer-generated VR content to accompany the GI narration. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the VR-GI experience.
|
Audio Only Guided Imagery (AO-GI)
n=12 participants at risk
Listen to narrative scripts based on traditional GI audio recordings. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the GI experience.
|
|---|---|---|
|
Product Issues
device usage
|
21.7%
5/23 • Number of events 5 • 2 weeks
For the VR-GI group, adverse events were calculated with 23 participants as one participant did not receive allocated intervention.
|
0.00%
0/12 • 2 weeks
For the VR-GI group, adverse events were calculated with 23 participants as one participant did not receive allocated intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place