Stress, PsychologicalNCT04111796
Nature-based Solutions for Work-related Stress
A study testing nature based solution for stress reduction in people with Stress, Psychological, run by Hasselt University at 1 site in Belgium.
Trial summary
Although exposure to nature has restorative effects on human health, beneficial effects of nature-based interventions in the working environment have been underexplored. The investigators aim to conduct a randomised controlled pilot study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- nature based solution for stress reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2019to 1 Nov 2019
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- work at province of Limburg speak dutch
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Province of Limburg
Hasselt, Limburg, 3590
Diana Clementa, 003211268289, diana.clemente@uhasselt.be
About this study
Official title: Nature-based Solutions for Work-related Stress: an Intervention Study
Although exposure to nature has restorative effects on human health, beneficial effects of nature-based interventions in the working environment have been underexplored. The investigators aim to conduct a randomised controlled pilot study.
During workhours one group participates in a nature-based program, the other group is a control group. The investigators test stress-related parameters including cortisol levels, wellbeing and stress, and neurocognition.
Read the detailed description
Participants of the intervention group follow a 30-minute stress management course in nature followed by a nature-based activity of 1.5 hours, twice a week for 3 consecutive weeks. The investigators measure neurocognition via neurocognitive tests, emotional status via burnout assessment tool and well-being questionnaires, and asses stress levels via salivary cortisol and smartwatches.
- Conditions
- Stress, Psychological
- Being tested
- nature based solution for stress reduction
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nature based solution for stress reductionOther
participation in nature activities: 30 min stress management in nature and group activity (walking, cycling)
| Study group | Role | What they receive |
|---|---|---|
| group in nature | Experimental | they participate in nature based-program during work hours Receives: Other: nature based solution for stress reduction |
| control group | No intervention | they participate don't in nature based-program during work hours and perform their normal work schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognition: selective attention
computerised tests (stroop test). The scale is mean reaction time and is used as a continuous variable.
Measured: 5 minutes
Neurocognition: short-term memory
computerised tests (Digit Span Test). The scale is number of digits and is used as a continuous variable.
Measured: 10 minutes
Neurocognition:visual information processing speed
computerised tests (Digit Symbol test). The scale is number of digits and is used as a continuous variable.
Measured: 5 minutes
Neurocognition: visual information processing speed
computerised tests (Pattern Comparison test ). The scale is reaction time and is used as a continuous variable.
Measured: 5 minutes
stress levels
Assessed by salivary cortisol levels. Scale is µg/dl and used as a continuous variable.
Measured: 5 minutes
stress levels
Assessed by questionnaires (burnout assessment tool). Scores are used as continuous variable. Lower scores represent lower risk of burnout, higher scores represent higher risk of burnout. The score is constructed from questions concerning exhaustion, mental distance, emotional disorder and cognitive disorder.
Measured: 10 minutes
stress levels
Assessed by smartwatch (algorithm including hart rate and movement). Values are used as continuous variable
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Aug 2019
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Plusquin, Hasselt University
- Investigators
- Michelle Plusquin, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111796
- Sponsor's protocol ID
- Nature_health
- Status last verified
- Oct 2019
- First submitted
- 27 Sep 2019
- Last updated
- 3 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be shared with postdoctoral researcher involved in this project in our research group. Data is pseudonymised .
Publications
Daniels S, Clemente DBP, Desart S, Saenen N, Sleurs H, Nawrot TS, Malina R, Plusquin M. Introducing nature at the work floor: A nature-based intervention to reduce stress and improve cognitive performance. Int J Hyg Environ Health. 2022 Mar;240:113884. doi: 10.1016/j.ijheh.2021.113884. Epub 2021 Nov 27.
PubMed 34847453
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nature-based Solutions for Work-related Stress: an Intervention Study
- ClinicalTrials.gov ID
- NCT04111796
- Acronym / sponsor ID
- Nature_health
- Conditions
- Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 1 Oct 2019 (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.
Although exposure to nature has restorative effects on human health, beneficial effects of nature-based interventions in the working environment have been underexplored. The investigators aim to conduct a randomised controlled pilot study.
During workhours one group participates in a nature-based program, the other group is a control group. The investigators test stress-related parameters including cortisol levels, wellbeing and stress, and neurocognition.
Detailed description
Participants of the intervention group follow a 30-minute stress management course in nature followed by a nature-based activity of 1.5 hours, twice a week for 3 consecutive weeks. The investigators measure neurocognition via neurocognitive tests, emotional status via burnout assessment tool and well-being questionnaires, and asses stress levels via salivary cortisol and smartwatches.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group in nature | Experimental | Other: nature based solution for stress reductionthey participate in nature based-program during work hours |
| control group | No intervention | –they participate don't in nature based-program during work hours and perform their normal work schedule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- work at province of Limburg speak dutch
Key exclusion criteria (1 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 |
|---|---|---|
| nature based solution for stress reductionparticipation in nature activities: 30 min stress management in nature and group activity (walking, cycling) | Other | group in nature |
Primary outcome
Neurocognition: selective attention
Time frame: 5 minutes
computerised tests (stroop test). The scale is mean reaction time and is used as a continuous variable.
Neurocognition: short-term memory
Time frame: 10 minutes
computerised tests (Digit Span Test). The scale is number of digits and is used as a continuous variable.
Neurocognition:visual information processing speed
Time frame: 5 minutes
computerised tests (Digit Symbol test). The scale is number of digits and is used as a continuous variable.
Neurocognition: visual information processing speed
Time frame: 5 minutes
computerised tests (Pattern Comparison test ). The scale is reaction time and is used as a continuous variable.
stress levels
Time frame: 5 minutes
Assessed by salivary cortisol levels. Scale is µg/dl and used as a continuous variable.
stress levels
Time frame: 10 minutes
Assessed by questionnaires (burnout assessment tool). Scores are used as continuous variable. Lower scores represent lower risk of burnout, higher scores represent higher risk of burnout. The score is constructed from questions concerning exhaustion, mental distance, emotional disorder and cognitive disorder.
stress levels
Time frame: 3 weeks
Assessed by smartwatch (algorithm including hart rate and movement). Values are used as continuous variable
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Derived from this study: PubMed 34847453Daniels S, Clemente DBP, Desart S, Saenen N, Sleurs H, Nawrot TS, Malina R, Plusquin M. Introducing nature at the work floor: A nature-based intervention to reduce stress and improve cognitive performance. Int J Hyg Environ Health. 2022 Mar;240:113884. doi: 10.1016/j.ijheh.2021.113884. Epub 2021 Nov 27.
- Individual participant dataSharing planned: No. Data will only be shared with postdoctoral researcher involved in this project in our research group. Data is pseudonymised .
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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.
Michelle Plusquin principal investigator
Hasselt 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 nature based solution for stress reduction in people with Stress, Psychological, run by Hasselt University at 1 site in Belgium.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Oct 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Plusquin (003211268289, michelle.plusquin@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognition: selective attention (time frame: 5 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04111796, which also lists 1 linked publication.
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 3 Oct 2019.