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NCT Number: NCT05492006

Immune Response and Affective States of Elderly and 50+ Individuals After Intentional and Indirect Contact With Nature

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.

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Key information

Conditions

Elderly

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Israelita Albert Einstein

São Paulo, 05652000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • individuals of both sexes
  • capable of physical and mental to carry out the proposed activities
  • capable of mental to fill in the questionnaires.

Exclusion criteria

  • 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

Treatment and study plan

Indirect contact with nature

Behavioral

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.

Other names: e-NatPOEM

Intentional contact with nature

Behavioral

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.

Other names: A time with e-Nature

Primary outcomes

  1. 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

  2. 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.

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.

    Time frame: immediately pre intervention, 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.

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Paulo de Tarso Ricieri de Lima

Registry information

Official study title

Immune Response and Affective States of Elderly and 50+ Individuals After Intentional and Indirect Contact With Nature: a Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Aug 8, 2022
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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