Chronic PainNCT03153891
Nature as a Buffer Among People With Chronic Pain
A study testing Natural Environment and Built Environment in people with Chronic Pain, run by Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Natural Environment and Built Environment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- rate health as "fair" "good" or "excellent"
- experience chronic pain
- cognitively intact
- do not use wheelchair
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Natural Environment, Built Environment
- Keywords
- environment, nature
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural EnvironmentOther
Also called VR nature
the natural environment will be delivered via Samsung VR gear goggles with Samsung smartphone.
Built EnvironmentOther
Also called VR built environment
the built environment will be delivered via Samsung VR gear goggles with Samsung smartphone.
| Study group | Role | What they receive |
|---|---|---|
| Natural Environment | Experimental | Participants experience a virtual reality natural environment intervention (using VR goggles with Smartphone) for 10 minutes on two occasions, 1 week apart. Receives: Other: Natural Environment |
| Built Environment | Experimental | Participants experience a virtual reality built environment intervention (using VR goggles with Smartphone) for 10 minutes on two occasions, 1 week apart. Receives: Other: Built Environment |
| Control | No intervention | Participants do not experience a VR intervention. Instead they visit with research assistants for 10 minutes on two occasions, 1 week apart. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience of chronic pain
rating of pain intensity, on scale of 1-10
Measured: up to 3 weeks; from date of randomization until 2nd data collection date
Secondary outcomes (2)
Pain catastrophizing
rate 13 items on 5-point scale (0-4) (Sullivan, et al., 2001)
Measured: up to 3 weeks; from date of randomization until 2nd data collection date
cognitive functioning
attention restoration - digit span forward \& backwards; Attention Network Test
Measured: up to 3 weeks; from date of randomization until 2nd data collection date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Jul 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy M Wells, PhD, Principal investigator, Design + Environmental Analysis, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153891
- Sponsor's protocol ID
- 1703006971
- Status last verified
- Mar 2019
- First submitted
- 11 May 2017
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Nature: Benefits for Older Adults Who Experience Chronic Pain?
- ClinicalTrials.gov ID
- NCT03153891
- Acronym / sponsor ID
- 1703006971
- Conditions
- Chronic Pain
- Keywords
- environment, nature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Natural Environment | Experimental | Other: Natural EnvironmentParticipants experience a virtual reality natural environment intervention (using VR goggles with Smartphone) for 10 minutes on two occasions, 1 week apart. |
| Built Environment | Experimental | Other: Built EnvironmentParticipants experience a virtual reality built environment intervention (using VR goggles with Smartphone) for 10 minutes on two occasions, 1 week apart. |
| Control | No intervention | –Participants do not experience a VR intervention. Instead they visit with research assistants for 10 minutes on two occasions, 1 week apart. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- rate health as "fair" "good" or "excellent"
- experience chronic pain
- cognitively intact
- do not use wheelchair
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural EnvironmentAlso: VR naturethe natural environment will be delivered via Samsung VR gear goggles with Samsung smartphone. | Other | Natural Environment |
| Built EnvironmentAlso: VR built environmentthe built environment will be delivered via Samsung VR gear goggles with Samsung smartphone. | Other | Built Environment |
Primary outcome
Experience of chronic pain
Time frame: up to 3 weeks; from date of randomization until 2nd data collection date
rating of pain intensity, on scale of 1-10
2 secondary outcomes
Pain catastrophizing
Time frame: up to 3 weeks; from date of randomization until 2nd data collection date
cognitive functioning
Time frame: up to 3 weeks; from date of randomization until 2nd data collection date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Individual participant dataSharing planned: No. There is not a plan to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy M Wells, PhD principal investigator
Design + Environmental Analysis, Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural Environment and Built Environment in people with Chronic Pain, run by Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience of chronic pain (time frame: up to 3 weeks; from date of randomization until 2nd data collection date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.