Effects of Urban Nature on Stress and Quality of Life

Not Applicable

Recruiting

• Conditions: Stress, Psychological

• Registration Number: NCT04780646
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

The aim of this study is to investigate the effects of regular nature therapy in urban nature with guidance of a licensed nature therapist on stress, quality of life and physical symptoms of subjects with elevated stress levels.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-28
• Study First Posted: 2021-03-03
• Study Start: 2022-06-29
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-25
• Primary Completion: 2024-10-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• stress with at least 4 of 10 points on the Numeric Analogue Scale (NAS) at least 1 month
• at least 3 of the following 8 stress-associated symptoms: sleep disturbances, inappetence or increased appetite, shoulder neck tension/back pain, tension headache, concentration disturbances, exhaustion, nervousness/irritability, stress-associated digestive complaints.

Exclusion Criteria

• serious acute or chronic diseases
• pregnancy or lactation
• known serious mental illness
• immobility or restriction for gymnastics exercises due to orthopaedic, neurological or other medical cause
• participation in another study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stress questionnaire (Cohen Perceived Stress Scale, CPSS)	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks	Change from Baseline in the CPSS, range from 0 to 4 in each item. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the positively stated items and then summing across all scale items while higher values meaning a higher grade of perceived stress.

Secondary Outcome Measures

Name	Time	Method
Zerssen symptom list (B-LR and B-LR')	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks	Assessing full scale, range 20-80, higher score meaning a better outcome
International Physical Activity Questionnaire (IPAQ)	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks	MET minutes represent the amount of energy expended carrying out physical activity. To get a continuous variable score from the IPAQ (MET minutes a week) we will consider walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS; higher score meaning better outcome; range 0 to around 3000 MET minutes a week
Sociodemographic Measurements	Date of Inclusion (Baseline)	Age, gender, marital status, number of people in household, education level, employment status, job, personal net income, household income
General Self-Efficacy Short Scale-3 (GSE-3)	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Perceived Benefits of Nature Questionnaire (PBNQ)	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks	mean score of the 11 items, range 1-7, lower score meaning a better outcome
Profile of Mood States (POMS)	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Behavioural questions: doctor visits and health	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks	amount of doctor visits, amount of sick leave days in the last 2 months
Expectation questions	Date of Inclusion (Baseline)	for intervention 1 and 2 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all)
Behavioural questions: cigarette consumption	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks	Number of cigarettes on average per day in the last month
Heart Rate (HR)	Date of inclusion (baseline), after 8 weeks, after 16 weeks	24h measuring by faros 180
Maslach Burnout Inventory (MBI)	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks	Assessing full scale, range 0-96, higher score meaning a better outcome
Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks	Assessing full scale, range 0-56, higher score meaning a better outcome
Flourishing Scale (FS)	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks	Assessing full scale, range 8-56, higher score meaning a better outcome
Behavioural questions: alcohol consumption	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks	Number of alcoholic beverages on average per week in the last month
Subjective Vitality Scale (SVS-G state)	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks	Assessing full scale, range from 0-28, lower score meaning a better outcome
Hospital Anxiety and Depression Scale (HADS)	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Behavioural questions: time in nature	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks	amount of hours spent in nature per week in the last month
Behavioural questions: nature as priority	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks	if spending time in nature is seen as a priority on a 6-point likert scale 1 (very strong) to 6 (nothing at all)
Heart Rate Variability (HRV)	Date of inclusion (baseline), after 8 weeks, after 16 weeks	24h measuring by faros 180

Trial Locations

Locations (1)

Charite University; 🇩🇪 Berlin, Germany