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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

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
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05492006