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Nature-based Solutions for Work-related Stress

Primary Purpose

Stress, Psychological

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

nature based solution for stress reduction

About this trial

This is an interventional prevention trial for Stress, Psychological

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

work at province of Limburg speak dutch

Exclusion Criteria:

Sites / Locations

Province of LimburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

group in nature

control group

Arm Description

they participate in nature based-program during work hours

they participate don't in nature based-program during work hours and perform their normal work schedule

Outcomes

Primary Outcome Measures

Neurocognition: selective attention

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

Neurocognition: short-term memory

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

Neurocognition:visual information processing speed

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

Neurocognition: visual information processing speed

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

stress levels

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

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.

stress levels

Assessed by smartwatch (algorithm including hart rate and movement). Values are used as continuous variable

Secondary Outcome Measures

Full Information

NCT ID

NCT04111796

First Posted

September 27, 2019

Last Updated

October 1, 2019

Sponsor

Hasselt University

1. Study Identification

Unique Protocol Identification Number

NCT04111796

Brief Title

Nature-based Solutions for Work-related Stress

Official Title

Nature-based Solutions for Work-related Stress: an Intervention Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

November 1, 2019 (Anticipated)

Study Completion Date

November 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hasselt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress, Psychological

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group in nature

Arm Type

Experimental

Arm Description

they participate in nature based-program during work hours

Arm Title

control group

Arm Type

No Intervention

Arm Description

they participate don't in nature based-program during work hours and perform their normal work schedule

Intervention Type

Other

Intervention Name(s)

nature based solution for stress reduction

Intervention Description

participation in nature activities: 30 min stress management in nature and group activity (walking, cycling)

Primary Outcome Measure Information:

Title

Neurocognition: selective attention

Description

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

Time Frame

5 minutes

Title

Neurocognition: short-term memory

Description

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

Time Frame

10 minutes

Title

Neurocognition:visual information processing speed

Description

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

Time Frame

5 minutes

Title

Neurocognition: visual information processing speed

Description

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

Time Frame

5 minutes

Title

stress levels

Description

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

Time Frame

5 minutes

Title

stress levels

Description

Time Frame

10 minutes

Title

stress levels

Description

Assessed by smartwatch (algorithm including hart rate and movement). Values are used as continuous variable

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: work at province of Limburg speak dutch Exclusion Criteria: -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michelle Plusquin

Phone

003211268289

michelle.plusquin@uhasselt.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michelle Plusquin

Organizational Affiliation

Hasselt University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Province of Limburg

City

Hasselt

State/Province

Limburg

ZIP/Postal Code

3590

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Diana Clementa

Phone

003211268289

diana.clemente@uhasselt.be

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data will only be shared with postdoctoral researcher involved in this project in our research group. Data is pseudonymised .

Citations:

PubMed Identifier

34847453

Citation

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.

Results Reference

derived

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Nature-based Solutions for Work-related Stress

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