NCT05249296

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2020

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

2.9 years

First QC Date

April 2, 2020

Last Update Submit

February 18, 2022

Conditions

Keywords

Green space

Outcome Measures

Primary Outcomes (10)

  • General health

    An questionnaire is used to collect sociodemographic data and life-style factors, including movement data and health of the participant

    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).

    10 minutes

  • cortisol level (stress levels)

    Assessed by salivary cortisol levels. Scale is µg/dl and used as a continuous variable.

    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.

    5 minutes

  • selective attention

    Computerized tests (stroop test). The scale is mean reaction time and is used as a continuous variable.

    5 minutes

  • short-term memory

    Computerized tests (Digit Span Test). The scale is number of digits and is used as a continuous variable.

    10minutes

  • visual information processing speed

    Computerized tests (Digit Symbol Test). The scale is number of digits and is used as a continuous variable.

    5 minutes

  • visual information processing speed

    Computerized tests (Pattern Comparison test). The scale is reaction time and is used as a continuous variable.

    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).

    30 minutes

  • Blood pressure

    Blood pressure is measured through an automated system. The results is used as a continuous variable in mmHg.

    5 minutes

Study Arms (2)

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.

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.

Other: Nature based solution for stress reduction

Interventions

participation in nature activities: daily 30 min walking in nature

Group 1: intervention/control groupGroup 2: control/intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Student of Hasselt university or university college PXL and dutch speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Hasselt, Limburg, 3590, Belgium

RECRUITING

Study Officials

  • Michelle Plusquin

    Hasselt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

April 2, 2020

First Posted

February 21, 2022

Study Start

February 10, 2020

Primary Completion

December 30, 2022

Study Completion

December 31, 2022

Last Updated

February 21, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Data is pseudonymized. Data will then only be shared with the predoctoral researchers involved in this project, within our research group.

Locations