- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03153891
Nature as a Buffer Among People With Chronic Pain
March 28, 2019 updated by: Cornell University
Virtual Nature: Benefits for Older Adults Who Experience Chronic Pain?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Ithaca, New York, United States, 14853
- Cornell University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- rate health as "fair" "good" or "excellent"
- experience chronic pain
- cognitively intact
- do not use wheelchair
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Natural Environment
Participants experience a virtual reality natural environment intervention (using VR goggles with Smartphone) for 10 minutes on two occasions, 1 week apart.
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the natural environment will be delivered via Samsung VR gear goggles with Samsung smartphone.
Other Names:
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Experimental: Built Environment
Participants experience a virtual reality built environment intervention (using VR goggles with Smartphone) for 10 minutes on two occasions, 1 week apart.
|
the built environment will be delivered via Samsung VR gear goggles with Samsung smartphone.
Other Names:
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No Intervention: Control
Participants do not experience a VR intervention.
Instead they visit with research assistants for 10 minutes on two occasions, 1 week apart.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Experience of chronic pain
Time Frame: up to 3 weeks; from date of randomization until 2nd data collection date
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rating of pain intensity, on scale of 1-10
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up to 3 weeks; from date of randomization until 2nd data collection date
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain catastrophizing
Time Frame: up to 3 weeks; from date of randomization until 2nd data collection date
|
rate 13 items on 5-point scale (0-4) (Sullivan, et al., 2001)
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up to 3 weeks; from date of randomization until 2nd data collection date
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cognitive functioning
Time Frame: up to 3 weeks; from date of randomization until 2nd data collection date
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attention restoration - digit span forward & backwards; Attention Network Test
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up to 3 weeks; from date of randomization until 2nd data collection date
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nancy M Wells, PhD, Design + Environmental Analysis, Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
May 11, 2017
First Submitted That Met QC Criteria
May 12, 2017
First Posted (Actual)
May 15, 2017
Study Record Updates
Last Update Posted (Actual)
April 1, 2019
Last Update Submitted That Met QC Criteria
March 28, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1703006971
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There is not a plan to share individual participant data with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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