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

NCT05315388 | Active Not Recruiting DMC

• 1 other identifier: 21-2021
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Natural Killer

  1 time per month for 6 months

• Beck Anxiety Inventory levels

  Three times for 6 months

• NR3C1 and FKBP5 gene methylation.

  Two times for 6 months

• Pittsburgh Sleep Quality levels

  Three times for 6 months

Study Arms (3)

Group 1. Regular therapy group

NO INTERVENTION

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 2A: Vitamin N therapy group - metropolitan park environment

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

Immersion therapy in nature - Vitamin N OTHER

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.

Also known as: Shinrin-yoku

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

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeadran N. Malagón-Rojas: lead

Study Sites (1)

Instituto Nacional de Salud

Bogotá, 111321, Colombia

Location

MeSH Terms

Conditions

ACTH Syndrome, Ectopic; Stress, Psychological; Anxiety Disorders

Interventions

Forest Therapy

Condition Hierarchy (Ancestors)

Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes; Neoplasms; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Relaxation Therapy; Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinator, Grupo de Salud Ambiental Laboral, Principal Investigator, Medicine, Msc, PhD(c)

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 7, 2022
• Study Start: October 15, 2022
• Primary Completion: December 30, 2023
• Study Completion: May 30, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)