Clinical trial NCT05315388: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Instituto Nacional de Salud, Colombia
Sponsor class: OTHER_GOV
First posted: 2022-04-07
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Concentration of Cortisol in saliva
timeFrame: 1 time per month for 6 months
measure: Outcome Measures in Arterial pressure levels
timeFrame: 4 time per month for 6 months
measure: Outcome Measures in Heart rate levels
timeFrame: 4 time per month for 6 months
measure: Change Psychological stress measurement scale levels
timeFrame: Three times for 6 months
Secondary outcomes:
measure: Natural Killer
timeFrame: 1 time per month for 6 months
measure: Beck Anxiety Inventory levels
timeFrame: Three times for 6 months
measure: NR3C1 and FKBP5 gene methylation.
timeFrame: Two times for 6 months
measure: Pittsburgh Sleep Quality levels
timeFrame: Three times for 6 months
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Instituto Nacional de Salud
Study officials:
References: