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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05492006




Registration number
NCT05492006
Ethics application status
Date submitted
5/08/2022
Date registered
8/08/2022
Date last updated
1/10/2024

Titles & IDs
Public title
Immune Response and Affective States of Elderly and 50+ Individuals After Intentional and Indirect Contact With Nature
Scientific title
Immune Response and Affective States of Elderly and 50+ Individuals After Intentional and Indirect Contact With Nature: a Randomized Controlled Clinical Trial
Secondary ID [1] 0 0
e-Nature NK
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elderly 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Indirect contact with nature
BEHAVIORAL - Intentional contact with nature

Active comparator: Group A: intentional contact with nature - Group A volunteers will take a light walk along the park with green space in a single 1-hour session with an emphasis on sense-directed appreciation guided by research team.

Active comparator: Group B: indirect contact with nature - The members of Group B will watch a video with the images of nature during 4 consecutive 15-minute sessions accompanied by the researcher, totaling 1 hour.


BEHAVIORAL: Indirect contact with nature
The participants will watch a video with validated images of nature from e-Nature Positive Emotions Photography Database (e-NatPOEM). Four fifteen-minute sessions will be held on four consecutive days, totaling 1 hour.

BEHAVIORAL: Intentional contact with nature
The participants will take a light walk in a park with green spaces guided by research team in a single 1-hour session, with an emphasis on sense-directed appreciation.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline Concentration of Cytokines in Soluble Immune Profile at 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention.
Timepoint [1] 0 0
immediately pre intervention, 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention
Primary outcome [2] 0 0
Change from baseline percentage and absolute number levels of Cellular Immune Profile at 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention
Timepoint [2] 0 0
immediately pre intervention, 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention.
Primary outcome [3] 0 0
Change from baseline percentage and absolute number levels of Cellular Immune Profile (others) at 30 minutes post intervention, within 48 hours and within 4 weeks post intervention
Timepoint [3] 0 0
immediately pre intervention, 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention.
Secondary outcome [1] 0 0
Change from baseline affective states at 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention.
Timepoint [1] 0 0
immediately pre intervention, 30 minutes post intervention, within 48 hours post intervention and within 4 weeks post intervention.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
São Paulo

Funding & Sponsors
Primary sponsor type
Other
Name
Hospital Israelita Albert Einstein
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Paulo de Tarso Ricieri de Lima
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT05492006
Trial related presentations / 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.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Eliseth R Leão, PhD
Address 0 0
Hospital Israelita Albert Einstein
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05492006