ElderlyNCT05492006
Immune Response and Affective States of Elderly and 50+ Individuals After Intentional and Indirect Contact With Nature
A study testing Indirect contact with nature and Intentional contact with nature in people with Elderly, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
Randomized clinical trial on the influence of intentional and indirect contact with nature on the immune response and affective states in people aged 50 years or older. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- Indirect contact with nature and Intentional contact with nature
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jun 2023to 30 Jun 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- individuals of both sexes
- capable of physical and mental to carry out the proposed activities
- capable of mental to fill in the questionnaires.
Who cannot join
- autoimmune diseases
- chronic or acute inflammatory diseases
- disease that affects the response of the immune system
- neuromuscular problems
- oncological diseases and neoplastic
- individuals being treated with immunosuppressive drugs or that affect the immune system
- individuals who are under the influence of alcohol or other substances that interfere with cognitive ability
- those who have had contact intentional relationship with nature in the 30-day period prior to participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune Response and Affective States of Elderly and 50+ Individuals After Intentional and Indirect Contact With Nature: a Randomized Controlled Clinical Trial
Randomized clinical trial on the influence of intentional and indirect contact with nature on the immune response and affective states in people aged 50 years or older.
Read the detailed description
Interaction with nature creates a state of physical relaxation, helping the individual to manage stress and promote health. Along with the ability to reduce stress, nature has been shown to improve immune function in some specific environments. Science already proves that stress conditions affect the immune capacity, generating pathological immune responses and inflammatory responses inappropriate. Therefore, if contact with nature is capable of reducing stress, through this study can find manifestations of improvement of the functions immunological.
This clinical trial aims to analyze intentional (Forest Bathing) and indirect contact (e-NatPOEM) with nature. After informed consent form, participants will be randomized to the study arms. Will be evaluated cells and enzymes of the of the immune system and affective states immediately before the intervention, 30 minutes post intervention, and within 48-72 hours and 25-35 days after the intervention. The hypothesis of our study is that both nature-based interventions will stimulate the immune system and will improve affective states. However, intentional direct contact with nature will have superior results than indirect contact.
- Conditions
- Elderly
- Being tested
- Indirect contact with nature, Intentional contact with nature
- Keywords
- health promotion, healthy aging, nature, immunological, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect contact with natureBehavioural
Also called e-NatPOEM
The participants will watch a video with validated images of nature from e-Nature Positive Emotions Photography Database (e-NatPOEM).
Participants will watch the material in a controlled environment, lasting approximately 45 minutes.
Intentional contact with natureBehavioural
Also called A time with e-Nature
The participants will take a light walk in a park with green spaces guided by research team in a single 1-hour session, based on the Multicomponent Nature-Based Intervention named A time with e-Nature. This intervention integrates multisensory, aesthetic-emotional, cognitive, and active-engagement dimensions.
| Study group | Role | What they receive |
|---|---|---|
| Group A: intentional contact with nature | Active comparator | Group A volunteers will take a light walk along the park with green space in a single 1-hour session guided by a Multicomponent Nature-Based Intervention grounded in the "A time with e-Nature" model. This intervention was developed by this same research group and integrates multisensory, aesthetic-emotional, cognitive, and active-engagement dimensions, constituting a structured and replicable protocol. Receives: Behavioral: Intentional contact with nature |
| Group B: indirect contact with nature | Active comparator | The members of Group B will watch a video with the images of the e-Nature Positive Emotions Photography Database (e-NatPOEM), a database of nature images validated by this same research group for its capacity to evoke positive emotions in a controlled manner. Participants will watch the material in a controlled environment, lasting approximately 45 minutes. Receives: Behavioral: Indirect contact with nature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Concentration of Cytokines in Soluble Immune Profile at 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention.
Quantify the change from baseline pre intervention in concentration of cytokines in plasma ng/ml (IFN-γ, IL-10, Granzyme A, IL-13, Granzyme B, IL-2, IL-4, IL-6, TNF-α e perforina) in comparison the concentrations between the periods of 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention
Measured: immediately pre intervention, 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention
Change from baseline of Cellular Immune Profile at 30 minutes post intervention, within 48-72 hours post intervention and within 25-25 days post intervention
Quantify the changes from baseline pre intervention of frequency of cellular immune populations and their inhibiting, activating, effector and lytic molecules of subpopulation of lymphocytes and NK cells and their memory status in the blood within the period of 30 minutes post intervention, 48-72 hours and 25-35 days post intervention.
Measured: immediately pre intervention, 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention.
Secondary outcomes (1)
Change from baseline affective states at 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention.
Will be applied the Profile of Mood States - POMS. It is one of the most used instruments in psychology to assess the states emotions and mood states, as well as the variation associated with them.
Assesses six domains: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Each item can be rated on a Likert-type frequency scale of sensations, ranging from 0 (not at all) to 4 (extremely). The scale final score indicates the Total Mood Disturbance.
Measured: immediately pre intervention, 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start20 Jun 2023
- Primary completion31 May 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Paulo de Tarso Ricieri de Lima
- Responsible party
- Sponsor
- Investigators
- Eliseth R Leão, PhD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492006
- Sponsor's protocol ID
- e-Nature NK
- Status last verified
- Mar 2025
- First submitted
- 5 Aug 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dal Fabbro D, Catissi G, Borba G, Lima L, Hingst-Zaher E, Rosa J, Victor E, Bernardes L, Souza T, Leao E. e-Nature Positive Emotions Photography Database (e-NatPOEM): affectively rated nature images promoting positive emotions. Sci Rep. 2021 Jun 3;11(1):11696. doi: 10.1038/s41598-021-91013-9.
PubMed 34083616
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response and Affective States of Elderly and 50+ Individuals After Intentional and Indirect Contact With Nature: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05492006
- Acronym / sponsor ID
- e-Nature NK
- Conditions
- Elderly
- Keywords
- health promotion, healthy aging, nature, immunological, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Paulo de Tarso Ricieri de Lima
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 8 Aug 2022 (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.
Randomized clinical trial on the influence of intentional and indirect contact with nature on the immune response and affective states in people aged 50 years or older.
Detailed description
Interaction with nature creates a state of physical relaxation, helping the individual to manage stress and promote health. Along with the ability to reduce stress, nature has been shown to improve immune function in some specific environments. Science already proves that stress conditions affect the immune capacity, generating pathological immune responses and inflammatory responses inappropriate. Therefore, if contact with nature is capable of reducing stress, through this study can find manifestations of improvement of the functions immunological.
This clinical trial aims to analyze intentional (Forest Bathing) and indirect contact (e-NatPOEM) with nature. After informed consent form, participants will be randomized to the study arms. Will be evaluated cells and enzymes of the of the immune system and affective states immediately before the intervention, 30 minutes post intervention, and within 48-72 hours and 25-35 days after the intervention. The hypothesis of our study is that both nature-based interventions will stimulate the immune system and will improve affective states. However, intentional direct contact with nature will have superior results than indirect contact.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: intentional contact with nature | Active comparator | Behavioral: Intentional contact with natureGroup A volunteers will take a light walk along the park with green space in a single 1-hour session guided by a Multicomponent Nature-Based Intervention grounded in the "A time with e-Nature" model. This intervention was developed by this same research group and integrates multisensory, aesthetic-emotional, cognitive, and active-engagement dimensions, constituting a structured and replicable protocol. |
| Group B: indirect contact with nature | Active comparator | Behavioral: Indirect contact with natureThe members of Group B will watch a video with the images of the e-Nature Positive Emotions Photography Database (e-NatPOEM), a database of nature images validated by this same research group for its capacity to evoke positive emotions in a controlled manner. Participants will watch the material in a controlled environment, lasting approximately 45 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- individuals of both sexes
- capable of physical and mental to carry out the proposed activities
- capable of mental to fill in the questionnaires.
Key exclusion criteria (8 listed)
- autoimmune diseases
- chronic or acute inflammatory diseases
- disease that affects the response of the immune system
- neuromuscular problems
- oncological diseases and neoplastic
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 |
|---|---|---|
| Indirect contact with natureAlso: e-NatPOEMThe participants will watch a video with validated images of nature from e-Nature Positive Emotions Photography Database (e-NatPOEM). Participants will watch the material in a controlled environment, lasting approximately 45 minutes. | Behavioural | Group B: indirect contact with nature |
| Intentional contact with natureAlso: A time with e-NatureThe participants will take a light walk in a park with green spaces guided by research team in a single 1-hour session, based on the Multicomponent Nature-Based Intervention named A time with e-Nature. This intervention integrates multisensory, aesthetic-emotional, cognitive, and active-engagement dimensions. | Behavioural | Group A: intentional contact with nature |
Primary outcome
Change from Baseline Concentration of Cytokines in Soluble Immune Profile at 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention.
Time frame: immediately pre intervention, 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention
Quantify the change from baseline pre intervention in concentration of cytokines in plasma ng/ml (IFN-γ, IL-10, Granzyme A, IL-13, Granzyme B, IL-2, IL-4, IL-6, TNF-α e perforina) in comparison the concentrations between the periods of 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention
Change from baseline of Cellular Immune Profile at 30 minutes post intervention, within 48-72 hours post intervention and within 25-25 days post intervention
Time frame: immediately pre intervention, 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention.
Quantify the changes from baseline pre intervention of frequency of cellular immune populations and their inhibiting, activating, effector and lytic molecules of subpopulation of lymphocytes and NK cells and their memory status in the blood within the period of 30 minutes post intervention, 48-72 hours and 25-35 days post intervention.
1 secondary outcome
Change from baseline affective states at 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention.
Time frame: immediately pre intervention, 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention.
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 23 Oct 2026.
- Background: PubMed 34083616Dal Fabbro D, Catissi G, Borba G, Lima L, Hingst-Zaher E, Rosa J, Victor E, Bernardes L, Souza T, Leao E. e-Nature Positive Emotions Photography Database (e-NatPOEM): affectively rated nature images promoting positive emotions. Sci Rep. 2021 Jun 3;11(1):11696. doi: 10.1038/s41598-021-91013-9.
- 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.
Eliseth R Leão, PhD principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect contact with nature and Intentional contact with nature in people with Elderly, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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 3 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 23 Oct 2026. 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 Brazil. 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?
Change from Baseline Concentration of Cytokines in Soluble Immune Profile at 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention. (time frame: immediately pre intervention, 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05492006, which also lists 1 linked publication.
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 23 Oct 2026.