Back to resultsNature as a Buffer Among People With Chronic Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Natural Environment
Built Environment
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Pain focused on measuring environment, nature
Eligibility Criteria
Inclusion Criteria:
- rate health as "fair" "good" or "excellent"
- experience chronic pain
- cognitively intact
- do not use wheelchair
Exclusion Criteria:
Sites / Locations
- Cornell University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Natural Environment
Built Environment
Control
Arm Description
Participants experience a virtual reality natural environment intervention (using VR goggles with Smartphone) for 10 minutes on two occasions, 1 week apart.
Participants experience a virtual reality built environment intervention (using VR goggles with Smartphone) for 10 minutes on two occasions, 1 week apart.
Participants do not experience a VR intervention. Instead they visit with research assistants for 10 minutes on two occasions, 1 week apart.
Outcomes
Primary Outcome Measures
Experience of chronic pain
rating of pain intensity, on scale of 1-10
Secondary Outcome Measures
Pain catastrophizing
rate 13 items on 5-point scale (0-4) (Sullivan, et al., 2001)
cognitive functioning
attention restoration - digit span forward & backwards; Attention Network Test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03153891
Brief Title
Nature as a Buffer Among People With Chronic Pain
Official Title
Virtual Nature: Benefits for Older Adults Who Experience Chronic Pain?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This randomized controlled trial examines the effect of nature exposure on pain intensity levels among older adults who experience chronic pain. Investigators examine the effects of nature on: the experience of chronic pain, on pain catastrophizing, and on attention restoration.
Detailed Description
Nature has been used to reduce pain in the context of acute pain (e.g., during painful medical procedures) but nature has not been examined as an intervention strategy to address chronic pain. Second, the mechanism though which nature might reduce the experience of pain is not well understood. Participants are cognitively intact individuals aged 60-90 who experience chronic pain and who rate their health as fair, good or excellent. Participants are randomly assigned to one of three conditions: virtual reality (VR) nature; VR built environment; or control. Researchers examine effects of VR nature exposure on the experience of chronic pain, pain catastrophizing, and on attention restoration as well as the relations among these variables.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
environment, nature
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Natural Environment
Arm Type
Experimental
Arm Description
Participants experience a virtual reality natural environment intervention (using VR goggles with Smartphone) for 10 minutes on two occasions, 1 week apart.
Arm Title
Built Environment
Arm Type
Experimental
Arm Description
Participants experience a virtual reality built environment intervention (using VR goggles with Smartphone) for 10 minutes on two occasions, 1 week apart.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants do not experience a VR intervention. Instead they visit with research assistants for 10 minutes on two occasions, 1 week apart.
Intervention Type
Other
Intervention Name(s)
Natural Environment
Other Intervention Name(s)
VR nature
Intervention Description
the natural environment will be delivered via Samsung VR gear goggles with Samsung smartphone.
Intervention Type
Other
Intervention Name(s)
Built Environment
Other Intervention Name(s)
VR built environment
Intervention Description
the built environment will be delivered via Samsung VR gear goggles with Samsung smartphone.
Primary Outcome Measure Information:
Title
Experience of chronic pain
Description
rating of pain intensity, on scale of 1-10
Time Frame
up to 3 weeks; from date of randomization until 2nd data collection date
Secondary Outcome Measure Information:
Title
Pain catastrophizing
Description
rate 13 items on 5-point scale (0-4) (Sullivan, et al., 2001)
Time Frame
up to 3 weeks; from date of randomization until 2nd data collection date
Title
cognitive functioning
Description
attention restoration - digit span forward & backwards; Attention Network Test
Time Frame
up to 3 weeks; from date of randomization until 2nd data collection date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
rate health as "fair" "good" or "excellent"
experience chronic pain
cognitively intact
do not use wheelchair
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy M Wells, PhD
Organizational Affiliation
Design + Environmental Analysis, Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cornell University
City
Ithaca
State/Province
New York
ZIP/Postal Code
14853
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to share individual participant data with other researchers.
Learn more about this trial
Nature as a Buffer Among People With Chronic Pain
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