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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05249296
Other study ID # Nature_Stress
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 10, 2020
Est. completion date December 31, 2022

Study information

Verified date February 2022
Source Hasselt University
Contact Michelle Plusquin
Phone +3211268289
Email michelle.plusquin@uhasselt.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Student of Hasselt university or university college PXL and dutch speaking Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nature based solution for stress reduction
participation in nature activities: daily 30 min walking in nature

Locations

Country Name City State
Belgium Hasselt University Hasselt Limburg

Sponsors (1)

Lead Sponsor Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary General health An questionnaire is used to collect sociodemographic data and life-style factors, including movement data and health of the participant 5 minutes
Primary 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). 10 minutes
Primary cortisol level (stress levels) Assessed by salivary cortisol levels. Scale is µg/dl and used as a continuous variable. 5 minutes
Primary 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. 5 minutes
Primary selective attention Computerized tests (stroop test). The scale is mean reaction time and is used as a continuous variable. 5 minutes
Primary short-term memory Computerized tests (Digit Span Test). The scale is number of digits and is used as a continuous variable. 10minutes
Primary visual information processing speed Computerized tests (Digit Symbol Test). The scale is number of digits and is used as a continuous variable. 5 minutes
Primary visual information processing speed Computerized tests (Pattern Comparison test). The scale is reaction time and is used as a continuous variable. 5 minutes
Primary 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). 30 minutes
Primary Blood pressure Blood pressure is measured through an automated system. The results is used as a continuous variable in mmHg. 5 minutes
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