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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05315388
Other study ID # 21-2021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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