VR Blue: Virtual Reality for Improving Pain and Distress in Patients With Advanced Stage Colorectal Cancer

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04069702
• Collaborator: University of Colorado, Denver (Other), Palliative Care Research Cooperative Group (Other), National Institute of Nursing Research (NINR) (NIH), National Institutes of Health (NIH) (NIH)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 16.2
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

Patients with advanced colorectal cancer often experience high levels of debilitating pain and pain-related psychological distress. Pain in cancer patients is typically treated with analgesics. There is growing agreement that non-pharmacological pain management strategies are needed to treat pain in advanced cancer patients. Recent evidence suggests Virtual Reality (VR) experiences can lead to reductions in acute pain; however, VR has not been tested in advanced cancer patients having persistent pain. VR could represent a valuable addition to our current armamentarium of treatments for persistent pain in palliative care patients. VR provides individuals with an immersive computer-generated environment that can reduce pain, tension and distress.

The proposed study builds upon and extends preliminary research in healthy participants conducted by Luana Colloca, MD, PhD. Dr. Colloca is a consultant on this project and the proposed study would be the first to extend VR Blue to a clinical population and test its effects on clinical pain. The objective is to gather initial data on advanced colorectal cancer patients' immediate response to a single VR session. The investigators will examine feasibility, acceptability, safety, and impact of exposure to VR Blue on the clinical pain experience of advanced colorectal cancer patients. The study will collect data on pain, tension and distress pre-, midpoint, and post-VR. The investigators will also examine how pre- to post-VR changes in key cognitive variables (i.e., pain catastrophizing, pain self-efficacy) relate to VR-related changes in pain, tension and distress.

The investigators will also collect qualitative data following participants' VR experience to better understand patients' preferences, thoughts and feelings about the VR experience. Data will be used to optimize VR Blue for future study, including developing an intervention to support a multi-session VR protocol for advanced colorectal cancer patients. The proposed study represents the first step in a program of clinical research that seeks to test the efficacy of VR in improving pain and pain-related symptoms in advanced colorectal cancer patients. In the proposed study, the investigators will collect quantitative and qualitative data on the impact of VR Blue on pain and pain-related outcomes in 20 advanced colorectal cancer patients.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Behavioral: VR Blue	N/A

Detailed Description

Patients with advanced colorectal cancer often experience high levels of debilitating pain and pain-related psychological distress. Pain in cancer patients is typically treated with analgesics. Unfortunately, analgesics are not uniformly effective and often are associated with poorly tolerated side effects (e.g., constipation, nausea, sedation). There is growing agreement that non-pharmacological pain management strategies are needed to treat pain in advanced cancer patients. Recent evidence suggests Virtual Reality (VR) experiences can lead to reductions in acute pain; however, VR has not been tested in advanced cancer patients having persistent pain. VR could represent a valuable addition to our current armamentarium of treatments for persistent pain in palliative care patients.

VR provides individuals with an immersive computer-generated environment that can reduce pain, tension and distress. VR may be particularly likely to positively impact cognitive pathways by changing pain-related cognitions (e.g., decreasing pain catastrophizing, increasing self-efficacy for pain control). VR-based interventions have the potential to alter these negative ways of thinking, and advanced cancer patients with persistent pain and pain-related distress may be particularly likely to benefit.

The proposed study builds upon and extends preliminary research in healthy participants conducted by Luana Colloca, MD, PhD. That study found that exposure to a 30-minute virtual underwater/sea environment (VR Blue) produced significant increases in pain tolerance for thermal pain stimuli compared to control conditions. Dr. Colloca is a consultant on this project and the proposed study would be the first to extend VR Blue to a clinical population and test its effects on clinical pain. The objective is to gather initial data on advanced colorectal cancer patients' immediate response to a single VR session. The investigators will examine feasibility, acceptability, safety, and impact of exposure to VR Blue on the clinical pain experience of advanced colorectal cancer patients. The study will collect data on pain, tension and distress pre-, midpoint, and post-VR. The investigators will also examine how pre- to post-VR changes in key cognitive variables (i.e., pain catastrophizing, pain self-efficacy) relate to VR-related changes in pain, tension and distress.

The investigators will also collect qualitative data following participants' VR experience to better understand patients' preferences, thoughts and feelings about the VR experience. Data will be used to optimize VR Blue for future study, including developing an intervention to support a multi-session VR protocol for advanced colorectal cancer patients. The proposed study represents the first step in a program of clinical research that seeks to test the efficacy of VR in improving pain and pain-related symptoms in advanced colorectal cancer patients. In the proposed study, the investigators will collect quantitative and qualitative data on the impact of VR Blue on pain and pain-related outcomes in 20 advanced colorectal cancer patients.

The long-term goal of this research is to improve quality of life in advanced colorectal cancer patients by decreasing pain, tension and distress. This project will provide preliminary data that will be used to inform and optimize development of a multi-session VR protocol to be tested in patients with advanced stage colorectal cancer that could be generalizable to other palliative care populations with pain.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Testing a Virtual Reality Protocol for Improving Pain and Pain-Related Distress in Patients With Advanced Stage Colorectal Cancer
• Actual Study Start Date: Mar 12, 2020
• Actual Primary Completion Date: Jul 19, 2021
• Actual Study Completion Date: Jul 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VR Blue VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.	Behavioral: VR Blue; VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.

Outcome Measures

Primary Outcome Measures

1. Feasibility, Assessed by Examining Number of Participants Accrued [6 months]

   Feasibility was assessed by examining number of participants accrued.

2. Feasibility, Assessed by Examining Number of Participants With >80% Adherence to the Protocol [30 minutes]

   Feasibility will be assessed by examining protocol adherence (>80% adherence to the protocol [defined in this study as the degree to which participants are willing and able to complete the 30-minute VR exposure])

3. Feasibility, Assessed by Number of Participants With Completed Data [90 minutes]

   Feasibility will be assessed by examining completed data (>80% data collected at the study appointment, including pre-, midpoint, and post-VR assessments)

4. Acceptability Using the Client Satisfaction Questionnaire [90 minutes]

   This questionnaire contains 10 items rated from 1=low acceptability to 4=high acceptability; scores are created by utilizing the Likert Scale to average Client Satisfaction Questionnaire answers resulting in a score range from 1-4. The participant will complete this acceptability questionnaire as part of their post-VR session assessment.

5. Number of Participants With VR Side Effects [30 minutes]

   Safety of the VR protocol will be assessed based on participants' report of VR side effects, such as motion sickness, dizziness, headache, nausea, or other negative physical reactions

Secondary Outcome Measures

1. Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI) [Pre-, post-VR session, approximately 90 minutes]

   Pain will be assessed with the Brief Pain Inventory (BPI). Patients will rate their "pain right now" from 0=no pain to 10=worst pain imaginable. An average of the responses to these items is used to create a single pain severity score.

2. Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale [Pre-VR session assessment]

   Pain interference will be assessed with the Brief Pain Inventory (BPI) - Pain Interference Scale. Patients will rate how much pain interfered with a variety of activities and mood states over the last 7 days from 0=does not interfere to 10=completely interferes. An average of the responses to these items is used to create a single pain severity score.

3. Change in Tension as Measured With the Visual Analog Scale (VAS) [Pre-, post-VR session. Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.]

   Visual Analog Scale (VAS) items are rated on a 0-100 scale. 0=no tension at all, 100=maximum tolerable tension. An average of the responses at each time-point were used to create a single score of change from pre-VR session to post-VR session.

4. Change in Distress as Measured With the Visual Analog Scale (VAS) [Pre- and post-VR session, Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.]

   Visual Analog Scale (VAS) items are rated on a 0-100 scale. 0=no stress at all, 100=maximum tolerable stress. An average of the responses at each time-point were used to create a single score of change from pre-VR session to post-VR session.

5. Change in Pain Catastrophizing as Measured With the Coping Strategies Questionnaire's Pain Catastrophizing Subscale [Pre- and post-VR session, approximately 90 minutes]

   Items will be rated on a scale ranging from 0=never do to 6=always do when in pain. An average of the responses to these items is used to create a single score of change from pre-VR session to post-VR session.

6. Change in Pain Self-efficacy as Measured Using Items Adapted From the Self-efficacy for Pain Management Subscale of the Chronic Pain Self-Efficacy Scale [Pre- and post-VR session, approximately 90 minutes]

   Self-efficacy will be measured using items adapted from the self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale. Items are rated on a 10-point scale ranging from 10=very uncertain to 100=very certain. Scores are averaged to give an overall value of change from pre-VR session to post-VR session for pain self-efficacy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age 18-85

• a diagnosis of stage IV colorectal cancer

• clinical pain documented in medical chart (>4 on a 0-10 scale) and confirmed on the day of their study appointment (>4 on a 0-10 scale)

• being able to read and speak English

• self-reported normal or corrected to normal vision

• self-reported normal hearing

Exclusion Criteria:

• a serious mental illness (e.g., schizophrenia, bipolar disorder) as indicated by medical records

• a medical condition that contraindicates safe participation in the study (e.g., recent myocardial infarction)

• visual, hearing, or cognitive impairment that will interfere with the patient's ability to engage in the intervention

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke Cancer Institute	Durham	North Carolina	United States	27701

Sponsors and Collaborators

• Duke University
• University of Colorado, Denver
• Palliative Care Research Cooperative Group
• National Institute of Nursing Research (NINR)
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Sarah A Kelleher, PhD, Duke University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 30, 2021
• Informed Consent Form - Jul 30, 2021

More Information

Additional Information:

• Pre-print: Daily Lactobacillus Probiotic versus Placebo in COVID-19-Exposed Household Contacts (PROTECT-EHC): A Randomized Clinical Trial

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04069702
• Other Study ID Numbers: Pro00103248; U2CNR014637
• First Posted: Aug 28, 2019
• Last Update Posted: Aug 22, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

Participant Flow

Arm/Group Title	VR Blue
Arm/Group Description	VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music. VR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	VR Blue
Arm/Group Description	VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music. VR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	17 85%
>=65 years	3 15%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.7 (10.7)
Sex: Female, Male (Count of Participants)
Female	6 30%
Male	14 70%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	18 90%
Unknown or Not Reported	2 10%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	1 5%
Black or African American	4 20%
White	15 75%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%
Pain Right Now (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.8 (1.4)

Outcome Measures

1. Primary Outcome

Title	Feasibility, Assessed by Examining Number of Participants Accrued
Description	Feasibility was assessed by examining number of participants accrued.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VR Blue
Arm/Group Description	VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music. VR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
Measure Participants	20
Count of Participants [Participants]	20 100%

2. Primary Outcome

Title	Feasibility, Assessed by Examining Number of Participants With >80% Adherence to the Protocol
Description	Feasibility will be assessed by examining protocol adherence (>80% adherence to the protocol [defined in this study as the degree to which participants are willing and able to complete the 30-minute VR exposure])
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VR Blue
Arm/Group Description	VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music. VR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
Measure Participants	20
Count of Participants [Participants]	20 100%

3. Primary Outcome

Title	Feasibility, Assessed by Number of Participants With Completed Data
Description	Feasibility will be assessed by examining completed data (>80% data collected at the study appointment, including pre-, midpoint, and post-VR assessments)
Time Frame	90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VR Blue
Arm/Group Description	VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music. VR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
Measure Participants	20
Count of Participants [Participants]	20 100%

4. Primary Outcome

Title	Acceptability Using the Client Satisfaction Questionnaire
Description	This questionnaire contains 10 items rated from 1=low acceptability to 4=high acceptability; scores are created by utilizing the Likert Scale to average Client Satisfaction Questionnaire answers resulting in a score range from 1-4. The participant will complete this acceptability questionnaire as part of their post-VR session assessment.
Time Frame	90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VR Blue
Arm/Group Description	VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music. VR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
Measure Participants	20
Mean (Standard Deviation) [score on a scale]	3.30 (0.41)

5. Primary Outcome

Title	Number of Participants With VR Side Effects
Description	Safety of the VR protocol will be assessed based on participants' report of VR side effects, such as motion sickness, dizziness, headache, nausea, or other negative physical reactions
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VR Blue
Arm/Group Description	VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music. VR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
Measure Participants	20
Count of Participants [Participants]	20 100%

6. Secondary Outcome

Title	Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI)
Description	Pain will be assessed with the Brief Pain Inventory (BPI). Patients will rate their "pain right now" from 0=no pain to 10=worst pain imaginable. An average of the responses to these items is used to create a single pain severity score.
Time Frame	Pre-, post-VR session, approximately 90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VR Blue
Arm/Group Description	VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music. VR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
Measure Participants	20
Mean (Standard Deviation) [score on a scale]	1.15 (1.14)

7. Secondary Outcome

Title	Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale
Description	Pain interference will be assessed with the Brief Pain Inventory (BPI) - Pain Interference Scale. Patients will rate how much pain interfered with a variety of activities and mood states over the last 7 days from 0=does not interfere to 10=completely interferes. An average of the responses to these items is used to create a single pain severity score.
Time Frame	Pre-VR session assessment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VR Blue
Arm/Group Description	VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music. VR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
Measure Participants	20
Mean (Standard Deviation) [score on a scale]	2.86 (2.07)

8. Secondary Outcome

Title	Change in Tension as Measured With the Visual Analog Scale (VAS)
Description	Visual Analog Scale (VAS) items are rated on a 0-100 scale. 0=no tension at all, 100=maximum tolerable tension. An average of the responses at each time-point were used to create a single score of change from pre-VR session to post-VR session.
Time Frame	Pre-, post-VR session. Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VR Blue
Arm/Group Description	VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music. VR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
Measure Participants	20
Mean (Standard Deviation) [score on a scale]	7.70 (12.70)

9. Secondary Outcome

Title	Change in Distress as Measured With the Visual Analog Scale (VAS)
Description	Visual Analog Scale (VAS) items are rated on a 0-100 scale. 0=no stress at all, 100=maximum tolerable stress. An average of the responses at each time-point were used to create a single score of change from pre-VR session to post-VR session.
Time Frame	Pre- and post-VR session, Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VR Blue
Arm/Group Description	VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music. VR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
Measure Participants	20
Mean (Standard Deviation) [score on a scale]	7.60 (13.59)

10. Secondary Outcome

Title	Change in Pain Catastrophizing as Measured With the Coping Strategies Questionnaire's Pain Catastrophizing Subscale
Description	Items will be rated on a scale ranging from 0=never do to 6=always do when in pain. An average of the responses to these items is used to create a single score of change from pre-VR session to post-VR session.
Time Frame	Pre- and post-VR session, approximately 90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VR Blue
Arm/Group Description	VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music. VR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
Measure Participants	20
Mean (Standard Deviation) [score on a scale]	0.88 (0.89)

11. Secondary Outcome

Title	Change in Pain Self-efficacy as Measured Using Items Adapted From the Self-efficacy for Pain Management Subscale of the Chronic Pain Self-Efficacy Scale
Description	Self-efficacy will be measured using items adapted from the self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale. Items are rated on a 10-point scale ranging from 10=very uncertain to 100=very certain. Scores are averaged to give an overall value of change from pre-VR session to post-VR session for pain self-efficacy.
Time Frame	Pre- and post-VR session, approximately 90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VR Blue
Arm/Group Description	VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music. VR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
Measure Participants	20
Mean (Standard Deviation) [score on a scale]	72.60 (16.49)

Adverse Events

Time Frame	Adverse event data was collected during the one-time study visit which lasted approximately 90 minutes.
Arm/Group Title	VR Blue
Arm/Group Description	VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music. VR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
All Cause Mortality
	VR Blue
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	VR Blue
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	VR Blue
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.