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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05486156
Other study ID # A time with e-Nature
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 8, 2022
Est. completion date June 24, 2023

Study information

Verified date August 2023
Source Hospital Israelita Albert Einstein
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized clinical trial to evaluate the efficacy of a multi-component nature-based intervention on clinical outcomes for visitors from different natural areas in Brazil.


Description:

There is a growing scientific literature that indicates a series of benefits of contact/connection with nature for health and well-being, such as the mental health improvement, hypertension improvement, restoration of attention and memory and immune system improvement. It is already known, among other findings, that contact with nature, even indirectly, through videos and photos, can promote a greater sense of relaxation, decrease stress levels and can promote positive emotions. The adoption of nature-based interventions has been expanded, both for the prevention of chronic health conditions and the promotion of general well-being, as well as for the treatment of physical, mental and social health. This clinical trial aims to assess the mean change in the World Health Organization well-being index, changes in self-perception of happiness, vitality, connection and engagement with nature in the pre-intervention, post-intervention and 30-day follow-up moments, in the control and intervention groups, in six different natural areas. In the multicomponent intervention, in addition to including walking in nature with attention to the senses, which will be carried out by the control group, the investigators associate other elements of a cognitive-behavioral nature, aiming human and non-human well-being. Therefore, in this health nature-based intervention, activities related to four types of experience are proposed (1- knowledge; 2- aesthetic/emotional; 3- integrated multisensory, 4- active experience). The study hypothesis is that Well-being, happiness and vitality outcomes will be more positive in the intervention group, and the connection with nature and engagement with conservation at 30 days post-intervention will be greater in the intervention group as well, due to adherence to nature-related activities that will be monitored and knowledge offered


Recruitment information / eligibility

Status Completed
Enrollment 486
Est. completion date June 24, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Voluntary participation; - Signed in the Informed Consent Form (able to understand and agree to participate in the study) - Have conditions of digital access to the link of the study questionnaires, which will be provided by the team. Exclusion Criteria: - Display walking difficulties; - Participants with phobia related to elements of nature; - History of allergies when in contact with nature.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
A Time with e-Nature
Integrated multisensory experience (aesthetic, emotional and knowledge) in two stages: Observation of nature through the senses (smell, hearing, sight, touch, taste) and the appreciative look. Observation focused on the local avifauna and flora during the trail accompanied by a research biologist from the group.

Locations

Country Name City State
Brazil Parque das Neblinas Bertioga SP
Brazil Reserva Particular de Patrimônio Natural Salto Morato Guaraqueçaba PR
Brazil Instituto Butantan Sao Paulo SP
Brazil Parque Estadual da Cantareira São Paulo
Brazil Parque Natural Municipal Fazenda do Carmo São Paulo SP
Brazil Parque Natural Municipal Varginha São Paulo SP

Sponsors (2)

Lead Sponsor Collaborator
Hospital Israelita Albert Einstein Fundação Grupo Boticário de Proteção à Natureza

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline Well-Being Index at immediate post-intervention and 30 days follow-up. The World Health Organization-5 Well-Being Index is a brief scale, composed of five questions in which the participants indicate in each one of them, based on the last two weeks, the frequency of their sensations, being 0 (at no time) and 5 (all of the time). The result is given as the sum of the numbers of each statement, with values ranging from 0, which represents the worst possible quality of life and 25, which is associated with the best possible quality of life. immediately pre and immediately post intervention and within 4 weeks post intervention
Secondary Change from baseline self-perception of happiness at immediate post-intervention and 30 days follow-up. A single question about ): "generally feel happy?" with an 11-point response scale (0-10) for providing a reliable and valid measure of well-being for community surveys. It is a numerical scale that varies from and used in various research ranging from 0 (extremely unhappy) to 10 (extremely happy). There is no founder of this scale being used freely as a numerical scale for several variables in which the individual can quantify in some way what is being studied. The score ranges from 0 to 10. The higher the score, the greater the happiness. immediately pre and immediately post intervention and within 4 weeks post intervention
Secondary Change from baseline vitality at immediate post-intervention and 30 days follow-up. Subjective Vitality Scale consists of seven items answered on a seven-point scale, ranging from 1 (not at all true) to 7 (completely true). The respondent needs to indicate how true what the item expresses about how he is currently feeling is true.The participant needs to indicate how true what the item expresses about how they are currently feeling is true. The score ranges from 7 to 49. The higher the score, the greater vitality. immediately pre and immediately post intervention and within 4 weeks post intervention
Secondary Change of Connection with Nature from baseline to 30 days post-intervention The Nature Connection Scale (NCS) is used to verify the affective aspect of the person-environment relationship. It is composed of 14 items that are answered on a Likert Scale of points, ranging from 1 (I totally disagree) to 5 (I totally agree). The score ranges from 14 to 70. The higher the score, the greater the connection with nature. Immediately Pre intervention and within 4 weeks post intervention
Secondary Change from baseline nature engagement at 30 days after intervention Nature engagement questions was developed by the project researchers themselves, with variables that trace the main motivations of the participants to go to nature, as well as variables related to the population's engagement with nature.
In this way, it will be used to assess the frequency, motivation and access to natural areas, as well as the engagement of participants in three dimensions (values, actions taken at home in favor of nature and nature conservation actions).These questions allow to calculate the percentage of engagement for each type of action.The higher the percentage, the higher the engagement.
Immediately Pre intervention and within 4 weeks post intervention
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