StressNCT05249296
The Impact of Green Spaces on the General Well-being and Stress of Students
A study testing Nature based solution for stress reduction in people with Stress and Neurocognition, run by Hasselt University at 1 site in Belgium.
Trial summary
The number of students with psychological problems is on the rise, due to a combination of increasing performance pressure, high expectations, difficulties handling stress, social pressure, and studying. Spending time in a green space has been shown to have positive effects on the mental and general health. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Neurocognition, 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
- 10 Feb 2020to 31 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Student of Hasselt university or university college PXL and dutch speaking
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Hasselt University
Hasselt, Limburg, 3590
Kenneth Vanbrabant, +32493714758, Kenneth.vanbrabant@uhasselt.be
Rossella Alfano, +3211268529, rossella.alfano@uhasselt.be
About this study
Official title: The Impact of Green Spaces on the General Well-being and Stress of Students: an Intervention Study
The number of students with psychological problems is on the rise, due to a combination of increasing performance pressure, high expectations, difficulties handling stress, social pressure, and studying. Spending time in a green space has been shown to have positive effects on the mental and general health. This project aims to alleviate the symptoms of mental fatigue and stress related disorders such as burn out in students by offering a nature-based activity.
Participants are asked to take a thirty-minute walk in a nature-based area for five consecutive days, followed by a control period (regular schedule of the participant) for five days, or vice versa. The investigators test stress-related parameters including concentration tests, cognitive tests, cortisol levels, and cardiovascular measurements.
Read the detailed description
This project aims study the effectiveness of nature-based solutions on the prevention of stress-related symptoms due to high study pressure in students. A nature-based physical activity is recommended once a day to prevent stress build-up and positively influence the cardiovascular system. Participants are randomized into two groups: the first group of participants are asked to walk a nature-based route near the University campus for thirty minutes per day for two weeks (phase 1). After each activity-based phase, a washout period of one week is implemented to avoid carry-over of results (phase 2 and 4). In the third phase, the participants are asked to resume their daily activities for two weeks (control). The second group undergo the same phases but reversed: participants start with two weeks of their usual daily activities, followed by two weeks of nature-based activity. After each phase, the investigators measure neurocognition through neurocognitive tests, the emotional status through detailed questionnaires and assess stress levels through cardiovascular measurements, including salivary cortisol levels of saliva collected upon awakening, 30 min after waking and at 8 pm.
- Conditions
- Stress, Neurocognition, Psychological, Cardiovascular
- Being tested
- Nature based solution for stress reduction
- Keywords
- Green space
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: daily 30 min walking in nature
| Study group | Role | What they receive |
|---|---|---|
| Group 1: intervention/control group | Experimental | Phase 1: Two weeks of green space intervention
Phase 2: One week wash out period Resume daily activities
Phase 3: Two weeks of 'daily activities' Regular, daily activities are resumed by the participants
Phase 4: One week wash out period Resume daily activities
Between each phase, detailed questionnaires, neurocognitive tests and cardiovascular measurements are taken from the participants. Receives: Other: Nature based solution for stress reduction |
| Group 2: control/intervention group | Experimental | Phase 1: Two weeks of 'daily activities' Regular, daily activities are resumed by the participants
Phase 2: One week wash out period Resume daily activities
Phase 3: Two weeks of green space intervention
Phase 4: One week wash out period Resume daily activities
Between each phase, detailed questionnaires, neurocognitive tests and cardiovascular measurements are taken from the participants. Receives: Other: Nature based solution for stress reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
General health
An questionnaire is used to collect sociodemographic data and life-style factors, including movement data and health of the participant
Measured: 5 minutes
Stress levels
Assessed via questionnaires (the burn out assessment tool (score 1-5) and general health questionnaire (score 0-12) and Five Item Well Being Index (score 0-100). Scores are used as continuous variables. Lower scores represent a lower risk of burn out, higher scores represent a higher risk of burnout. The score is constructed from questions concerning exhaustion, mental distance, emotional disorder(s), and cognitive disorder(s).
Measured: 10 minutes
cortisol level (stress levels)
Assessed by salivary cortisol levels. Scale is µg/dl and used as a continuous variable.
Measured: 5 minutes
visual memory
Computerized tests (eye-tracking test). The scale is pupil size, spontaneous blinking rate and eye movements and is used as a continuous variable.
Measured: 5 minutes
selective attention
Computerized tests (stroop test). The scale is mean reaction time and is used as a continuous variable.
Measured: 5 minutes
short-term memory
Computerized tests (Digit Span Test). The scale is number of digits and is used as a continuous variable.
Measured: 10minutes
visual information processing speed
Computerized tests (Digit Symbol Test). The scale is number of digits and is used as a continuous variable.
Measured: 5 minutes
visual information processing speed
Computerized tests (Pattern Comparison test). The scale is reaction time and is used as a continuous variable.
Measured: 5 minutes
Heart rate variability
The heart rate is monitored throughout the entire baseline and follow-up visit through a small patch attached to the participant's skin. The results is used as a continuous variable in milliseconds (ms).
Measured: 30 minutes
Blood pressure
Blood pressure is measured through an automated system. The results is used as a continuous variable in mmHg.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start10 Feb 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Crossover
- 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
- NCT05249296
- Sponsor's protocol ID
- Nature_Stress
- Status last verified
- Feb 2022
- First submitted
- 2 Apr 2020
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is pseudonymized. Data will then only be shared with the predoctoral researchers involved in this project, within our research group.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Green Spaces on the General Well-being and Stress of Students: an Intervention Study
- ClinicalTrials.gov ID
- NCT05249296
- Acronym / sponsor ID
- Nature_Stress
- Conditions
- Stress, Neurocognition, Psychological, Cardiovascular
- Keywords
- Green space
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Feb 2022 (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.
The number of students with psychological problems is on the rise, due to a combination of increasing performance pressure, high expectations, difficulties handling stress, social pressure, and studying. Spending time in a green space has been shown to have positive effects on the mental and general health. This project aims to alleviate the symptoms of mental fatigue and stress related disorders such as burn out in students by offering a nature-based activity.
Participants are asked to take a thirty-minute walk in a nature-based area for five consecutive days, followed by a control period (regular schedule of the participant) for five days, or vice versa. The investigators test stress-related parameters including concentration tests, cognitive tests, cortisol levels, and cardiovascular measurements.
Detailed description
This project aims study the effectiveness of nature-based solutions on the prevention of stress-related symptoms due to high study pressure in students. A nature-based physical activity is recommended once a day to prevent stress build-up and positively influence the cardiovascular system. Participants are randomized into two groups: the first group of participants are asked to walk a nature-based route near the University campus for thirty minutes per day for two weeks (phase 1). After each activity-based phase, a washout period of one week is implemented to avoid carry-over of results (phase 2 and 4). In the third phase, the participants are asked to resume their daily activities for two weeks (control). The second group undergo the same phases but reversed: participants start with two weeks of their usual daily activities, followed by two weeks of nature-based activity. After each phase, the investigators measure neurocognition through neurocognitive tests, the emotional status through detailed questionnaires and assess stress levels through cardiovascular measurements, including salivary cortisol levels of saliva collected upon awakening, 30 min after waking and at 8 pm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: intervention/control group | Experimental | Other: Nature based solution for stress reductionPhase 1: Two weeks of green space intervention Phase 2: One week wash out period Resume daily activities Phase 3: Two weeks of 'daily activities' Regular, daily activities are resumed by the participants Phase 4: One week wash out period Resume daily activities Between each phase, detailed questionnaires, neurocognitive tests and cardiovascular measurements are taken from the participants. |
| Group 2: control/intervention group | Experimental | Other: Nature based solution for stress reductionPhase 1: Two weeks of 'daily activities' Regular, daily activities are resumed by the participants Phase 2: One week wash out period Resume daily activities Phase 3: Two weeks of green space intervention Phase 4: One week wash out period Resume daily activities Between each phase, detailed questionnaires, neurocognitive tests and cardiovascular measurements are taken from the participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Student of Hasselt university or university college PXL and dutch speaking
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: daily 30 min walking in nature | Other | Group 1: intervention/control group, Group 2: control/intervention group |
Primary outcome
General health
Time frame: 5 minutes
An questionnaire is used to collect sociodemographic data and life-style factors, including movement data and health of the participant
Stress levels
Time frame: 10 minutes
Assessed via questionnaires (the burn out assessment tool (score 1-5) and general health questionnaire (score 0-12) and Five Item Well Being Index (score 0-100). Scores are used as continuous variables. Lower scores represent a lower risk of burn out, higher scores represent a higher risk of burnout. The score is constructed from questions concerning exhaustion, mental distance, emotional disorder(s), and cognitive disorder(s).
cortisol level (stress levels)
Time frame: 5 minutes
Assessed by salivary cortisol levels. Scale is µg/dl and used as a continuous variable.
visual memory
Time frame: 5 minutes
Computerized tests (eye-tracking test). The scale is pupil size, spontaneous blinking rate and eye movements and is used as a continuous variable.
selective attention
Time frame: 5 minutes
Computerized tests (stroop test). The scale is mean reaction time and is used as a continuous variable.
short-term memory
Time frame: 10minutes
Computerized tests (Digit Span Test). The scale is number of digits and is used as a continuous variable.
visual information processing speed
Time frame: 5 minutes
Computerized tests (Digit Symbol Test). The scale is number of digits and is used as a continuous variable.
visual information processing speed
Time frame: 5 minutes
Computerized tests (Pattern Comparison test). The scale is reaction time and is used as a continuous variable.
Heart rate variability
Time frame: 30 minutes
The heart rate is monitored throughout the entire baseline and follow-up visit through a small patch attached to the participant's skin. The results is used as a continuous variable in milliseconds (ms).
Blood pressure
Time frame: 5 minutes
Blood pressure is measured through an automated system. The results is used as a continuous variable in mmHg.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Individual participant dataSharing planned: No. Data is pseudonymized. Data will then only be shared with the predoctoral researchers involved in this project, within our research group.
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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 and Neurocognition, 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 21 Feb 2022. 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 (+3211268289, michelle.plusquin@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General health (time frame: 5 minutes). The study lists 10 primary outcomes in all. 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 21 Feb 2022.