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

Anxiety Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05315388
• Other study ID #: 21-2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: October 30, 2024

Study information

• Verified date: March 2022
• Source: Instituto Nacional de Salud, Colombia
• Contact: Jeadran Malagon, MSc PhD (C)
• Phone: +57 2207720
• Email: jmalagon[@]ins.gov.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: October 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 62 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Environmental Exposure
• Epigenetic Disorder
• Natural Killer Cell Cytokine Production
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
Colombia	Instituto Nacional de Salud	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Jeadran N. Malagón-Rojas

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Outcome Measures in Arterial pressure levels	Blood pressure in mm Hg before and after surgery	4 time per month for 6 months
Primary	Outcome Measures in Heart rate levels	Determination by digital sphygmomanometers	4 time per month for 6 months
Primary	Change Psychological stress measurement scale levels	Determination of a score of the level of occupational stress through different	Three times for 6 months
Secondary	Natural Killer	Proportion of natural killer cells by flow cytometry.	1 time per month for 6 months
Secondary	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
Secondary	NR3C1 and FKBP5 gene methylation.	Percentage of methylation of NR3C1 and FKBP5 genes.	Two times for 6 months
Secondary	Pittsburgh Sleep Quality levels	Determination of a sleep quality score through different items taken into account in this instrument.	Three times for 6 months