Trial Outcomes & Findings for Virtual Reality for Improving Pain and Distress in Patients With Advanced Stage Colorectal Cancer (NCT NCT04069702)

Results Overview

Feasibility was assessed by examining number of participants accrued.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

6 months

Results posted on

2023-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	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. VR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VR Blue n=20 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	56.7 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 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	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	15 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
Pain Right Now	2.8 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Feasibility was assessed by examining number of participants accrued.

Outcome measures

Outcome measures
Measure	VR Blue n=20 Participants 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.
Feasibility, Assessed by Examining Number of Participants Accrued	20 Participants

PRIMARY outcome

Timeframe: 30 minutes

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

Outcome measures

Outcome measures
Measure	VR Blue n=20 Participants 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.
Feasibility, Assessed by Examining Number of Participants With >80% Adherence to the Protocol	20 Participants

PRIMARY outcome

Timeframe: 90 minutes

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

Outcome measures

Outcome measures
Measure	VR Blue n=20 Participants 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.
Feasibility, Assessed by Number of Participants With Completed Data	20 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	VR Blue n=20 Participants 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.
Acceptability Using the Client Satisfaction Questionnaire	3.30 score on a scale Standard Deviation 0.41

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	VR Blue n=20 Participants 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.
Number of Participants With VR Side Effects	20 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	VR Blue n=20 Participants 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.
Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI)	1.15 score on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	VR Blue n=20 Participants 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.
Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale	2.86 score on a scale Standard Deviation 2.07

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	VR Blue n=20 Participants 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.
Change in Tension as Measured With the Visual Analog Scale (VAS)	7.70 score on a scale Standard Deviation 12.70

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	VR Blue n=20 Participants 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.
Change in Distress as Measured With the Visual Analog Scale (VAS)	7.60 score on a scale Standard Deviation 13.59

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	VR Blue n=20 Participants 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.
Change in Pain Catastrophizing as Measured With the Coping Strategies Questionnaire's Pain Catastrophizing Subscale	0.88 score on a scale Standard Deviation 0.89

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	VR Blue n=20 Participants 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.
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	72.60 score on a scale Standard Deviation 16.49

Adverse Events

VR Blue

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

Sarah Kelleher, PhD

Duke University

Phone: 9194163405

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place