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Effects of Urban Nature on Stress and Quality of Life

Primary Purpose

Stress, Psychological

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Nature therapy in urban nature
City Walk
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological focused on measuring Nature therapy, Stress

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charite UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Nature therapy in urban nature

City Walk

Waiting List

Arm Description

Subjects receive a 90-minute nature therapy session once per week for 8 weeks with a licensed nature therapist, who explains exercises on perceiving nature and the connection between nature and health.

Subjects receive a 90-minute city walk through urban sourroundings once per week for 8 weeks with a city guide, who talks about city architecture and gives information about the history of the surroundings.

Subjects don't receive any therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Zerssen symptom list (B-LR and B-LR')
Assessing full scale, range 20-80, higher score meaning a better outcome
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
Maslach Burnout Inventory (MBI)
Assessing full scale, range 0-96, higher score meaning a better outcome
Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)
Assessing full scale, range 0-56, higher score meaning a better outcome
General Self-Efficacy Short Scale-3 (GSE-3)
Perceived Benefits of Nature Questionnaire (PBNQ)
mean score of the 11 items, range 1-7, lower score meaning a better outcome
Subjective Vitality Scale (SVS-G state)
Assessing full scale, range from 0-28, lower score meaning a better outcome
Flourishing Scale (FS)
Assessing full scale, range 8-56, higher score meaning a better outcome
Hospital Anxiety and Depression Scale (HADS)
Profile of Mood States (POMS)
Sociodemographic Measurements
Age, gender, marital status, number of people in household, education level, employment status, job, personal net income, household income
Behavioural questions: doctor visits and health
amount of doctor visits, amount of sick leave days in the last 2 months
Expectation questions
for intervention 1 and 2 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all)
Behavioural questions: cigarette consumption
Number of cigarettes on average per day in the last month
Behavioural questions: alcohol consumption
Number of alcoholic beverages on average per week in the last month
Behavioural questions: time in nature
amount of hours spent in nature per week in the last month
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)
Heart Rate (HR)
24h measuring by faros 180
Heart Rate Variability (HRV)
24h measuring by faros 180

Full Information

First Posted
February 22, 2021
Last Updated
October 24, 2023
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT04780646
Brief Title
Effects of Urban Nature on Stress and Quality of Life
Official Title
Effects of Urban Nature on Stress and Quality of Life of Subjects With Elevated Stress Levels - a Three-armed Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
October 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
Nature therapy, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
93 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nature therapy in urban nature
Arm Type
Experimental
Arm Description
Subjects receive a 90-minute nature therapy session once per week for 8 weeks with a licensed nature therapist, who explains exercises on perceiving nature and the connection between nature and health.
Arm Title
City Walk
Arm Type
Active Comparator
Arm Description
Subjects receive a 90-minute city walk through urban sourroundings once per week for 8 weeks with a city guide, who talks about city architecture and gives information about the history of the surroundings.
Arm Title
Waiting List
Arm Type
No Intervention
Arm Description
Subjects don't receive any therapy.
Intervention Type
Behavioral
Intervention Name(s)
Nature therapy in urban nature
Intervention Description
Nature therapy means visits in nature, actively perceiving the flora and fauna
Intervention Type
Behavioral
Intervention Name(s)
City Walk
Intervention Description
City Walk means walking through urban surroundings (houses, streets, concrete..) with as little as possible contact to nature
Primary Outcome Measure Information:
Title
Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
Description
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.
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary Outcome Measure Information:
Title
Zerssen symptom list (B-LR and B-LR')
Description
Assessing full scale, range 20-80, higher score meaning a better outcome
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
International Physical Activity Questionnaire (IPAQ)
Description
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
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
Maslach Burnout Inventory (MBI)
Description
Assessing full scale, range 0-96, higher score meaning a better outcome
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)
Description
Assessing full scale, range 0-56, higher score meaning a better outcome
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
General Self-Efficacy Short Scale-3 (GSE-3)
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
Perceived Benefits of Nature Questionnaire (PBNQ)
Description
mean score of the 11 items, range 1-7, lower score meaning a better outcome
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
Subjective Vitality Scale (SVS-G state)
Description
Assessing full scale, range from 0-28, lower score meaning a better outcome
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
Flourishing Scale (FS)
Description
Assessing full scale, range 8-56, higher score meaning a better outcome
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
Profile of Mood States (POMS)
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
Sociodemographic Measurements
Description
Age, gender, marital status, number of people in household, education level, employment status, job, personal net income, household income
Time Frame
Date of Inclusion (Baseline)
Title
Behavioural questions: doctor visits and health
Description
amount of doctor visits, amount of sick leave days in the last 2 months
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
Expectation questions
Description
for intervention 1 and 2 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all)
Time Frame
Date of Inclusion (Baseline)
Title
Behavioural questions: cigarette consumption
Description
Number of cigarettes on average per day in the last month
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
Behavioural questions: alcohol consumption
Description
Number of alcoholic beverages on average per week in the last month
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
Behavioural questions: time in nature
Description
amount of hours spent in nature per week in the last month
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
Behavioural questions: nature as priority
Description
if spending time in nature is seen as a priority on a 6-point likert scale 1 (very strong) to 6 (nothing at all)
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
Heart Rate (HR)
Description
24h measuring by faros 180
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Heart Rate Variability (HRV)
Description
24h measuring by faros 180
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Other Pre-specified Outcome Measures:
Title
Qualitative interviews in individual interviews
Description
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.
Time Frame
8 weeks after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Rösner
Phone
00493080505682
Email
m.roesner@immanuel.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Michalsen, Prof. Dr.
Organizational Affiliation
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite University
City
Berlin
ZIP/Postal Code
14169
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Rösner
Phone
+4980505682
Email
naturheilkunde.studien@immanuel.de
First Name & Middle Initial & Last Name & Degree
Andreas Michalsen, MD

12. IPD Sharing Statement

Learn more about this trial

Effects of Urban Nature on Stress and Quality of Life

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