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

Sponsor
Jeadran N. Malagón-Rojas (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05315388
Collaborator
(none)
118
1
3
24.5
4.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Immersion therapy in nature - Vitamin N
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Prevention
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.
Anticipated Study Start Date :
Oct 15, 2022
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Oct 30, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Concentration of Cortisol in saliva [1 time per month for 6 months]

      Saliva samples from each subject will be obtained with the Salivette device during each day of the intervention.

    2. Outcome Measures in Arterial pressure levels [4 time per month for 6 months]

      Blood pressure in mm Hg before and after surgery

    3. Outcome Measures in Heart rate levels [4 time per month for 6 months]

      Determination by digital sphygmomanometers

    4. Change Psychological stress measurement scale levels [Three times for 6 months]

      Determination of a score of the level of occupational stress through different

    Secondary Outcome Measures

    1. Natural Killer [1 time per month for 6 months]

      Proportion of natural killer cells by flow cytometry.

    2. Beck Anxiety Inventory levels [Three times for 6 months]

      Determination of a score of the level of anxiety through different items taken into account in this instrument.

    3. NR3C1 and FKBP5 gene methylation. [Two times for 6 months]

      Percentage of methylation of NR3C1 and FKBP5 genes.

    4. Pittsburgh Sleep Quality levels [Three times for 6 months]

      Determination of a sleep quality score through different items taken into account in this instrument.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 62 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto Nacional de Salud Bogotá Colombia 111321

    Sponsors and Collaborators

    • Jeadran N. Malagón-Rojas

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeadran N. Malagón-Rojas, Coordinator, Grupo de Salud Ambiental Laboral, Principal Investigator, Medicine, Msc, PhD(c), Instituto Nacional de Salud, Colombia
    ClinicalTrials.gov Identifier:
    NCT05315388
    Other Study ID Numbers:
    • 21-2021
    First Posted:
    Apr 7, 2022
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jeadran N. Malagón-Rojas, Coordinator, Grupo de Salud Ambiental Laboral, Principal Investigator, Medicine, Msc, PhD(c), Instituto Nacional de Salud, Colombia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 7, 2022