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

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stress, Psychological; Anxiety; Environmental Exposure; Cortisol Excess; Epigenetic Disorder; Natural Killer Cell Cytokine Production
• Intervention / Treatment: Other: Immersion therapy in nature - Vitamin N

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Bogotá, Colombia, 111321
    • Instituto Nacional de Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 62 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group 1. Regular therapy group; 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.
Experimental: Group 2A: Vitamin N therapy group - metropolitan park environment; 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.	Other: Immersion therapy in nature - Vitamin N; 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.; Other Names: Shinrin-yoku
Experimental: Group 2B: Vitamin N therapy group - forest forest environment; 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	Other: Immersion therapy in nature - Vitamin N; 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.; Other Names: Shinrin-yoku

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Cortisol in saliva	Saliva samples from each subject will be obtained with the Salivette device during each day of the intervention.	1 time per month for 6 months
Outcome Measures in Arterial pressure levels	Blood pressure in mm Hg before and after surgery	4 time per month for 6 months
Outcome Measures in Heart rate levels	Determination by digital sphygmomanometers	4 time per month for 6 months
Change Psychological stress measurement scale levels	Determination of a score of the level of occupational stress through different	Three times for 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Natural Killer	Proportion of natural killer cells by flow cytometry.	1 time per month for 6 months
Beck Anxiety Inventory levels	Determination of a score of the level of anxiety through different items taken into account in this instrument.	Three times for 6 months
NR3C1 and FKBP5 gene methylation.	Percentage of methylation of NR3C1 and FKBP5 genes.	Two times for 6 months
Pittsburgh Sleep Quality levels	Determination of a sleep quality score through different items taken into account in this instrument.	Three times for 6 months

Collaborators and Investigators

• Sponsor: Jeadran N. Malagón-Rojas

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; Cortisol; Blood pressure; Nature therapy; DNA Methylation; Natural Killer; Forest therapy; Psychological stress; Physiological stress
• Additional Relevant MeSH Terms: Behavioral Symptoms; Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Stress, Psychological; Cushing Syndrome; Physiological Effects of Drugs; Micronutrients; Vitamins
• Other Study ID Numbers: 21-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No