StressNCT04394039
Post-Pandemic Perception of Public Space in Singapore
A study testing Public space exposure in people with Stress and Anxiety, run by National University of Singapore at 1 site in Singapore.
Trial summary
In this study it is aimed to investigate the difference between the brain response to different urban environments in Singapore before and after the COVID-19 pandemic. The datasets acquired from 34 healthy individuals as part of ongoing study "Effects of Landscape on the Brain" (IRB Ref #: S-18-352) will be used. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- What is being tested?
- Public space exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jun 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 21 to 75
- Right-handed only
Who cannot join
- left-handed
- serious visual or auditory impairment
- Major neurological disorders e.g. epilepsy, stroke
- Any form of cancer
- Major heart diseases: e.g. ischemic heart disease
- Major lung diseases: e.g. chronic obstructive pulmonary disorder.
- Major liver disease e.g. liver failure
- Major kidney disease e.g. kidney failure
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Institute for Health Innovation & Technology (iHealthtech)
Singapore, 117599
About this study
Official title: Effects of COVID-19-Related Self-isolation on Psychological Response to Different Outdoor Environments in Singapore - Before & After Brain and Behavior Study
In this study it is aimed to investigate the difference between the brain response to different urban environments in Singapore before and after the COVID-19 pandemic. The datasets acquired from 34 healthy individuals as part of ongoing study "Effects of Landscape on the Brain" (IRB Ref #: S-18-352) will be used. These datasets consist of neurophysiological data recordings and behavioral self-reported measures and were collected before 20 of January 2020. The same experimental protocol would be followed, given that the data collection in the lab-setting would start after 7 th May 2020/whenever research activities are allowed to resume, and the outdoor sessions after the "circuit-breaker" period in Singapore is over.
Read the detailed description
The aim is to explore the difference between pre and post COVID-19-related isolation on their perception of green and public spaces, as well as mood, neuroelectrical (EEG) and haemodynamic (fNIRS) response.
The hypothesi is that crowded, busy public spaces, such as experimental site near Chinatown MRT, may induce more patterns of brain activity related to stress, anxiety and aversive attitudes after COVID-19 as compared to before. Similarily, it is expected that green urban spaces, such as experimental site at Hortpark, perceived after COVID-19 can elicit more salutogenic effect of relaxation, positive emotions and attention restoration than before the pandemic.
This study will allow better understanding of the mental health consequences of unprecedented period of isolation at home and social distancing. The relationship between city residents and their living environment may change due to COVID-19 and it's very important to uncover the mental health implications of social distancing to prepare for potential future outbreaks through developing tools and solutions addressing specific issues. Finally, for the urban planning and design the study may highlight important trends in changing human perception of space and redefine the concept of a "healthy city".
- Being tested
- Public space exposure
- Keywords
- landscape, exposure, EEG, fNIRS, stress, urban, self-isolation, covid-19, pandemic, public space, brain
- Medical subject headings
- Anxiety Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Public space exposureOther
landscapes with nature and/or classified as contemplative (through a CLM psychometric measure) are expected to elicit different brainwave oscillations as compared to noncontemplative ones.
| Study group | Role | What they receive |
|---|---|---|
| public sp exposures | Experimental | All participants undergo the procedure of visiting all landscape exposures in a random order. Receives: Other: Public space exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG power in alpha band
predictor of positive affect and positive mental health outcomes, measured with EEG
Measured: 5 minutes
EEG power in beta band
more beta in the right temporal lobes associated with stimuli-driven attention, measured with EEG
Measured: 5 minutes
fNIRS haemodynamics
decreased oxy-hemoglobin in the frontal part of the brain indicates more relaxation
Measured: 5 minutes
Secondary outcomes (2)
Profile of mood states
self-reported, pre-and post- stimulation Profile of Mood States (POMS) scale measures the change in the momentary mood, giving as an outcome measure the Total Mood Disturbance (TMD), where 1 is neutral, and above 1 is disturbed mood
Measured: 30 minutes
landscape preference measured with self-assessment manikin scale
measured using pictorial Self-Asessment Manikin (SAM) where score ranged from -3 to +3, where the lower the score the less positive (valence + arousal) emotions are caused by looking at the view
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Jun 2020
- Primary completion1 Aug 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- within-subjects before/ after study
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University Hospital, Singapore
- Responsible party
- Principal investigator, Agnieszka Olszewska-Guizzo, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394039
- Sponsor's protocol ID
- NUS-IRB_S-20-12
- Status last verified
- Jul 2021
- First submitted
- 13 May 2020
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of COVID-19-Related Self-isolation on Psychological Response to Different Outdoor Environments in Singapore - Before & After Brain and Behavior Study
- ClinicalTrials.gov ID
- NCT04394039
- Acronym / sponsor ID
- NUS-IRB_S-20-12
- Keywords
- landscape, exposure, EEG, fNIRS, stress, urban, self-isolation, covid-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- National University Hospital, Singapore
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study it is aimed to investigate the difference between the brain response to different urban environments in Singapore before and after the COVID-19 pandemic. The datasets acquired from 34 healthy individuals as part of ongoing study "Effects of Landscape on the Brain" (IRB Ref #: S-18-352) will be used. These datasets consist of neurophysiological data recordings and behavioral self-reported measures and were collected before 20 of January 2020. The same experimental protocol would be followed, given that the data collection in the lab-setting would start after 7 th May 2020/whenever research activities are allowed to resume, and the outdoor sessions after the "circuit-breaker" period in Singapore is over.
Detailed description
The aim is to explore the difference between pre and post COVID-19-related isolation on their perception of green and public spaces, as well as mood, neuroelectrical (EEG) and haemodynamic (fNIRS) response.
The hypothesi is that crowded, busy public spaces, such as experimental site near Chinatown MRT, may induce more patterns of brain activity related to stress, anxiety and aversive attitudes after COVID-19 as compared to before. Similarily, it is expected that green urban spaces, such as experimental site at Hortpark, perceived after COVID-19 can elicit more salutogenic effect of relaxation, positive emotions and attention restoration than before the pandemic.
This study will allow better understanding of the mental health consequences of unprecedented period of isolation at home and social distancing. The relationship between city residents and their living environment may change due to COVID-19 and it's very important to uncover the mental health implications of social distancing to prepare for potential future outbreaks through developing tools and solutions addressing specific issues. Finally, for the urban planning and design the study may highlight important trends in changing human perception of space and redefine the concept of a "healthy city".
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- within-subjects before/ after study
| Arm | Type | Receives |
|---|---|---|
| public sp exposures | Experimental | Other: Public space exposureAll participants undergo the procedure of visiting all landscape exposures in a random order. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age of 21 to 75
- Right-handed only
Key exclusion criteria (8 listed)
- left-handed
- serious visual or auditory impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Public space exposurelandscapes with nature and/or classified as contemplative (through a CLM psychometric measure) are expected to elicit different brainwave oscillations as compared to noncontemplative ones. | Other | public sp exposures |
Primary outcome
EEG power in alpha band
Time frame: 5 minutes
predictor of positive affect and positive mental health outcomes, measured with EEG
EEG power in beta band
Time frame: 5 minutes
more beta in the right temporal lobes associated with stimuli-driven attention, measured with EEG
fNIRS haemodynamics
Time frame: 5 minutes
decreased oxy-hemoglobin in the frontal part of the brain indicates more relaxation
2 secondary outcomes
Profile of mood states
Time frame: 30 minutes
landscape preference measured with self-assessment manikin scale
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Public space exposure in people with Stress and Anxiety, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG power in alpha band (time frame: 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.