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Effects of "Vitamin N" Nature Immersion Therapy on Stress Levels in Health Care Workers in the City of Bogotá

Primary Purpose

Cortisol Excess, Stress, Psychological, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Immersion therapy in nature - Vitamin N
Sponsored by
Jeadran N. Malagón-Rojas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cortisol Excess focused on measuring Forest therapy, Nature therapy, Cortisol, Psychological stress, Physiological stress, Anxiety, Blood pressure, Natural Killer, DNA Methylation

Eligibility Criteria

18 Years - 62 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Persons over 18 years of age
  • Health care workers
  • Prioritized by the psychosocial risk program
  • Complete vaccination schedule for COVID-19

Exclusion Criteria:

  • Undergraduate students in the area of health sciences
  • Pregnant women
  • Allergies or sensitivity to the intervention
  • Workers who consume immunosuppressants or corticosteroids
  • Workers diagnosed with any type of disease or who have undergone chemotherapy or radiotherapy treatment during the last year
  • Persons who have had exposure to X-rays in the last 6 months

Sites / Locations

  • Instituto Nacional de Salud

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Group 1. Regular therapy group

Group 2A: Vitamin N therapy group - metropolitan park environment

Group 2B: Vitamin N therapy group - forest forest environment

Arm Description

Group without intervention during the study period no changes will be made in their daily routine. They will receive a weekly intervention operationalized for psychosocial risk.

Group with periodic outings to a neighborhood or metropolitan natural park (once a week) for approximately 2 hours for a minimum period of six months.

Group with periodic outings to a forest environment (once a week) for a time of approximately 2 hours for a minimum period of six months

Outcomes

Primary Outcome Measures

Concentration of Cortisol in saliva
Saliva samples from each subject will be obtained with the Salivette device during each day of the intervention.
Outcome Measures in Arterial pressure levels
Blood pressure in mm Hg before and after surgery
Outcome Measures in Heart rate levels
Determination by digital sphygmomanometers
Change Psychological stress measurement scale levels
Determination of a score of the level of occupational stress through different

Secondary Outcome Measures

Natural Killer
Proportion of natural killer cells by flow cytometry.
Beck Anxiety Inventory levels
Determination of a score of the level of anxiety through different items taken into account in this instrument.
NR3C1 and FKBP5 gene methylation.
Percentage of methylation of NR3C1 and FKBP5 genes.
Pittsburgh Sleep Quality levels
Determination of a sleep quality score through different items taken into account in this instrument.

Full Information

First Posted
March 18, 2022
Last Updated
March 29, 2022
Sponsor
Jeadran N. Malagón-Rojas
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1. Study Identification

Unique Protocol Identification Number
NCT05315388
Brief Title
Effects of "Vitamin N" Nature Immersion Therapy on Stress Levels in Health Care Workers in the City of Bogotá
Official Title
Effects of "Vitamin N" Nature Immersion Therapy on Stress Levels in Health Care Workers in the City of Bogotá: an Intervention Evaluation Study, 2022 - 2024.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2022 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeadran N. Malagón-Rojas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Recent studies on health personnel in Colombia have evidenced the considerable increase in the levels of stress and anxiety, among other psychological disorders, as a product of the COVID-19 pandemic that is being experienced since 2019 and that implies a greater demand for attention from the affected citizens, with the consequent work overload and tension due to the risk of contagion. Thus, the present work will allow the generation of new knowledge in relation to the benefits of Vitamin N therapy in Colombia; which can contribute quickly and effectively to the reduction of stress levels, anxiety, insomnia, and depression in individuals, when compared with conventional interventions and result in possible benefits such as the reduction of health problems such as obesity, diabetes, high blood pressure, and diseases associated with the immune system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cortisol Excess, Stress, Psychological, Anxiety, Epigenetic Disorder, Natural Killer Cell Cytokine Production, Environmental Exposure
Keywords
Forest therapy, Nature therapy, Cortisol, Psychological stress, Physiological stress, Anxiety, Blood pressure, Natural Killer, DNA Methylation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel intervention evaluation study that will consider two interventions; the conscious immersion therapy in nature (Vitamin N) and the usual intervention designed by the company for psychosocial risk reduction.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1. Regular therapy group
Arm Type
No Intervention
Arm Description
Group without intervention during the study period no changes will be made in their daily routine. They will receive a weekly intervention operationalized for psychosocial risk.
Arm Title
Group 2A: Vitamin N therapy group - metropolitan park environment
Arm Type
Experimental
Arm Description
Group with periodic outings to a neighborhood or metropolitan natural park (once a week) for approximately 2 hours for a minimum period of six months.
Arm Title
Group 2B: Vitamin N therapy group - forest forest environment
Arm Type
Experimental
Arm Description
Group with periodic outings to a forest environment (once a week) for a time of approximately 2 hours for a minimum period of six months
Intervention Type
Other
Intervention Name(s)
Immersion therapy in nature - Vitamin N
Other Intervention Name(s)
Shinrin-yoku
Intervention Description
Usual therapy group The first saliva sample will be taken upon awakening to determine cortisol concentration. At their workplace, they will be asked to remain seated and silent for 3 minutes, the following will be taken: blood pressure, heart rate, psychological instruments (stress-anxiety), blood sample. Group 2A and Group 2B In the natural environment, a saliva sample will be taken upon awakening to determine cortisol concentration. After arrival at the site, they will be asked to remain seated and silent for 3 minutes, the following will be taken: blood pressure, heart rate, psychological instruments (stress-anxiety), blood sample. The first phase is a session of observation of the site for 15 minutes. A slow, unhurried walk will be performed for 1 hour and 45 minutes. The order of activities (sitting and walking) will be established to ensure reliability of physiological measurements.
Primary Outcome Measure Information:
Title
Concentration of Cortisol in saliva
Description
Saliva samples from each subject will be obtained with the Salivette device during each day of the intervention.
Time Frame
1 time per month for 6 months
Title
Outcome Measures in Arterial pressure levels
Description
Blood pressure in mm Hg before and after surgery
Time Frame
4 time per month for 6 months
Title
Outcome Measures in Heart rate levels
Description
Determination by digital sphygmomanometers
Time Frame
4 time per month for 6 months
Title
Change Psychological stress measurement scale levels
Description
Determination of a score of the level of occupational stress through different
Time Frame
Three times for 6 months
Secondary Outcome Measure Information:
Title
Natural Killer
Description
Proportion of natural killer cells by flow cytometry.
Time Frame
1 time per month for 6 months
Title
Beck Anxiety Inventory levels
Description
Determination of a score of the level of anxiety through different items taken into account in this instrument.
Time Frame
Three times for 6 months
Title
NR3C1 and FKBP5 gene methylation.
Description
Percentage of methylation of NR3C1 and FKBP5 genes.
Time Frame
Two times for 6 months
Title
Pittsburgh Sleep Quality levels
Description
Determination of a sleep quality score through different items taken into account in this instrument.
Time Frame
Three times for 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Persons over 18 years of age Health care workers Prioritized by the psychosocial risk program Complete vaccination schedule for COVID-19 Exclusion Criteria: Undergraduate students in the area of health sciences Pregnant women Allergies or sensitivity to the intervention Workers who consume immunosuppressants or corticosteroids Workers diagnosed with any type of disease or who have undergone chemotherapy or radiotherapy treatment during the last year Persons who have had exposure to X-rays in the last 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeadran Malagon, MSc PhD (C)
Phone
+57 2207720
Ext
1216
Email
jmalagon@ins.gov.co
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Marcela Paredes Céspedes, MSc PhD
Phone
+57 2207720
Ext
1216
Email
dianis910326@gmail.com
Facility Information:
Facility Name
Instituto Nacional de Salud
City
Bogotá
ZIP/Postal Code
111321
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeadran Malagón, Msc PhD (c)
Phone
+572007720
Ext
1216
Email
jmalagon@ins.gov.co
First Name & Middle Initial & Last Name & Degree
Diana M Paredes Céspedes, Msc PhD
First Name & Middle Initial & Last Name & Degree
Norida N Vélez Cuellar, Msc PhD
First Name & Middle Initial & Last Name & Degree
Yesith Toloza, Basic
First Name & Middle Initial & Last Name & Degree
Eliana Tellez, Lda
First Name & Middle Initial & Last Name & Degree
Eliana Parra, Msc
First Name & Middle Initial & Last Name & Degree
Julia Almentero, Lda

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of "Vitamin N" Nature Immersion Therapy on Stress Levels in Health Care Workers in the City of Bogotá

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