Effects of Urban Nature on Stress and Quality of Life

Stress, Psychological Clinical Trial

Official title:

Effects of Urban Nature on Stress and Quality of Life of Subjects With Elevated Stress Levels - a Three-armed Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04780646
• Other study ID #: Stadtnatur
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: October 2023
• Source: Charite University, Berlin, Germany
• Contact: Miriam Rösner
• Phone: 00493080505682
• Email: m.roesner[@]immanuel.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: December 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

Behavioral:
• Nature therapy in urban nature
Nature therapy means visits in nature, actively perceiving the flora and fauna
• City Walk
City Walk means walking through urban surroundings (houses, streets, concrete..) with as little as possible contact to nature

Locations

Country	Name	City	State
Germany	Charite University	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative interviews in individual interviews	Qualitative assessment will be carried out in 45-minute individual interviews in 20 (randomized selected) patients participating in the study. The interviews will be recorded, transcribed and analyzed with qualitative content analysis.	8 weeks after inclusion
Primary	Stress questionnaire (Cohen Perceived Stress Scale, CPSS)	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.	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	Zerssen symptom list (B-LR and B-LR')	Assessing full scale, range 20-80, higher score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	International Physical Activity Questionnaire (IPAQ)	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	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	Maslach Burnout Inventory (MBI)	Assessing full scale, range 0-96, higher score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)	Assessing full scale, range 0-56, higher score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	General Self-Efficacy Short Scale-3 (GSE-3)		Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	Perceived Benefits of Nature Questionnaire (PBNQ)	mean score of the 11 items, range 1-7, lower score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	Subjective Vitality Scale (SVS-G state)	Assessing full scale, range from 0-28, lower score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	Flourishing Scale (FS)	Assessing full scale, range 8-56, higher score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	Hospital Anxiety and Depression Scale (HADS)		Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	Profile of Mood States (POMS)		Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	Sociodemographic Measurements	Age, gender, marital status, number of people in household, education level, employment status, job, personal net income, household income	Date of Inclusion (Baseline)
Secondary	Behavioural questions: doctor visits and health	amount of doctor visits, amount of sick leave days in the last 2 months	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	Expectation questions	for intervention 1 and 2 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all)	Date of Inclusion (Baseline)
Secondary	Behavioural questions: cigarette consumption	Number of cigarettes on average per day in the last month	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	Behavioural questions: alcohol consumption	Number of alcoholic beverages on average per week in the last month	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	Behavioural questions: time in nature	amount of hours spent in nature per week in the last month	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	Behavioural questions: nature as priority	if spending time in nature is seen as a priority on a 6-point likert scale 1 (very strong) to 6 (nothing at all)	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	Heart Rate (HR)	24h measuring by faros 180	Date of inclusion (baseline), after 8 weeks, after 16 weeks
Secondary	Heart Rate Variability (HRV)	24h measuring by faros 180	Date of inclusion (baseline), after 8 weeks, after 16 weeks