Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06274229
Other study ID # EA4/252/23
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 20, 2024
Est. completion date December 31, 2025

Study information

Verified date February 2024
Source Charite University, Berlin, Germany
Contact Farid I Kandil, PhD
Phone +493080505
Email farid-ihab.kandil@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To reduce stress among urban residents, the consortium members of the European Council Horizon 2020 research program DivAirCity install different stress reducing, noise reducing and air quality improving means in the five cities of the consortium. This study measures physiological and psychological stress and health factors before and after the implementation of the project (at intervention sites) and compares the change (improvement) to the change in comparable places where no means were installed (control site).


Description:

Scientific studies show that increased stress can favor the development of e.g. high blood pressure, heart disease, mental illness, infectious diseases, headaches and sleep disorders. This means that stress causes considerable costs for western healthcare systems, including in our city and this neighbourhood. In large cities, where there are often hardly any natural green and forest areas left, depression and anxiety syndromes, for example, are more common than among the rural population. For example, in Germany, more than three quarters of the population live in densely or moderately populated areas, while the global average is more than 50 per cent. Due to increasing urbanisation, people living in cities will be heavily dependent on urban nature, which can be a relevant health-promoting factor. Several studies have shown that natural spaces such as city parks, parks and even greenery on streets have a positive impact on the health of residents, both individually and collectively. The European Council Horizon 2020 project DivAirCity (acronym explanation in the text below) is about making formerly busy public spaces in European cities more attractive again for residents and citizens. The aim is to redesign the spaces in such a way that people of different age groups, social classes and identities ("Div") can (once again) come together and meet in these places on a daily basis. To this end, these places are to be changed through various installations (planting trees, redesigning parks, shading, watering in summer) in such a way that the local air quality ("Air") in the cities ("City") improves significantly. This is realized on the one hand by installing air quality measuring equipment and by recording the number of people and the time they spend in these places (objective measurements). In addition to these objective measurements, this study records the impact on psychological and physiological health that the installations (intervention) has on the residents. To this end, it will be measured how residents feel in terms of quality of life, current stress, general health, and whether they feel safe and secure in the specific place (comfort, safety and security) and whether they enjoy going there and staying there,. These measurements will take place both before (day -60 to day -30) and after (day +30 and day +60) the installment of the intervention. Finally, we would like to know your age group, your gender and how close you live to the location of the conversion/installation. We would like to invite you to take part in this survey again after the remodelling project.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants must live or work at or near the installation (intervention group) or control site (control group) Exclusion Criteria: - none

Study Design


Intervention

Other:
Air pollution and noise reducing installations
A number of means to reduce traffic noise and traffic exhausts and improve air quality will be implemented at designated urban spaces (intervention sites), while other places with comparable amount of traffic and no such changes will serve as control sites.

Locations

Country Name City State
Germany Charité -- Universitaetsmedizin Berlin Berlin

Sponsors (6)

Lead Sponsor Collaborator
Charite University, Berlin, Germany European Commission, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, Universitat Politècnica de València, Universitatea din Bucuresti, University of Aarhus

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Questionnaire for General Physiological Health Custom-made Questionnaire Baseline: 60 to 30 days before the installation implementation vs Posttest: 30 to 60 days after the installation has been implemented
Other Questionnaire about feelings of safety and security at the site Custom-made Questionnaire Baseline: 60 to 30 days before the installation implementation vs Posttest: 30 to 60 days after the installation has been implemented
Primary WHO-5 Well-being Scale Validated Questionnaire Baseline: 60 to 30 days before the installation implementation vs Posttest: 30 to 60 days after the installation has been implemented
Secondary Kessler K6 psychological distress Validated Questionnaire Baseline: 60 to 30 days before the installation implementation vs Posttest: 30 to 60 days after the installation has been implemented
Secondary ASKU questionnaire Validates Questionnaire for self-efficacy Baseline: 60 to 30 days before the installation implementation vs Posttest: 30 to 60 days after the installation has been implemented
See also
  Status Clinical Trial Phase
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed NCT05703087 - Positive Cueing in Knee Arthroplasty. N/A
Completed NCT02541240 - Effects of an Intervention to Enhance Resilience in Physical Therapy Students N/A
Completed NCT02629016 - Stress Reduction: A Pilot Study With Adolescents N/A
Completed NCT01406028 - Does Emotional Support Decrease In Vitro Fertilization Stress? N/A
Completed NCT00121160 - Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response Phase 1
Completed NCT02621775 - Effectiveness of Two Stress Management Programs in Adaptation Disorder With Anxiety (ADA) N/A
Recruiting NCT04474418 - Psychometric Characterization of Patients With Cardiac Arrhythmias
Completed NCT03310112 - Mindfulness Training in U.S. Army Cohorts N/A
Terminated NCT03893617 - Brief Stresses Experimental Study Phase 1
Active, not recruiting NCT05542498 - Promoting Stress Management and Engagement in Introductory Physics Courses With Mindfulness and Relaxation N/A
Completed NCT02394899 - Improving Parental Psychosocial Functioning and Early Developmental Outcomes in Children With Sickle Cell Disease N/A
Terminated NCT00962273 - The Pandemic Stress Vaccine: A Resource to Enhance the Resilience of Healthcare Workers Facing an Infectious Outbreak N/A
Completed NCT00451126 - Moderating Impact of Various Emotion Personality Factors on Salivary Cortisol Response to a TSST N/A
Completed NCT06051500 - Psychological and Physiological Effects of Different Objects of Breath Meditation N/A
Completed NCT02801045 - Art Therapy in Palliative Care: Study of Identification and Understanding of the Mechanisms of Change in the Patient N/A
Completed NCT03308344 - Mindfulness Training in Military Spouses N/A
Recruiting NCT06029348 - Cerebrovascular Health and Resilience in Midlife N/A
Completed NCT04484649 - Sleeping Healthy/Living Healthy Development N/A
Completed NCT05869006 - The Effect of Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice on Psychological Well-Being and Creativity N/A