Cortisol ExcessNCT05315388
Effects of "Vitamin N" Nature Immersion Therapy on Stress Levels in Health Care Workers in the City of Bogotá
A study testing Immersion therapy in nature - Vitamin N in people with Cortisol Excess and Stress, Psychological, run by Jeadran N. Malagón-Rojas at 1 site in Colombia.
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… Read more about this study
- Who is it for?
- Ages 18 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Cortisol Excess, Stress, Psychological, Anxiety
- What is being tested?
- Immersion therapy in nature - Vitamin N
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteColombia
- Study dates
- 15 Oct 2022to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Persons over 18 years of age
- Health care workers
- Prioritized by the psychosocial risk program
- Complete vaccination schedule for COVID-19
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Immersion therapy in nature - Vitamin N
- Keywords
- Forest therapy, Nature therapy, Cortisol, Psychological stress, Physiological stress, Anxiety, Blood pressure, Natural Killer, DNA Methylation
- Medical subject headings
- ACTH Syndrome, Ectopic, Stress, Psychological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersion therapy in nature - Vitamin NOther
Also called Shinrin-yoku
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Immersion therapy in nature - Vitamin N |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Cortisol in saliva
Saliva samples from each subject will be obtained with the Salivette device during each day of the intervention.
Measured: 1 time per month for 6 months
Outcome Measures in Arterial pressure levels
Blood pressure in mm Hg before and after surgery
Measured: 4 time per month for 6 months
Outcome Measures in Heart rate levels
Determination by digital sphygmomanometers
Measured: 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
Measured: Three times for 6 months
Secondary outcomes (4)
Natural Killer
Proportion of natural killer cells by flow cytometry.
Measured: 1 time per month for 6 months
Beck Anxiety Inventory levels
Determination of a score of the level of anxiety through different items taken into account in this instrument.
Measured: Three times for 6 months
NR3C1 and FKBP5 gene methylation.
Percentage of methylation of NR3C1 and FKBP5 genes.
Measured: Two times for 6 months
Pittsburgh Sleep Quality levels
Determination of a sleep quality score through different items taken into account in this instrument.
Measured: Three times for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start15 Oct 2022
- Primary completion30 Dec 2023
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cortisol ExcessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeadran N. Malagón-Rojas
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Jeadran N. Malagón-Rojas, Instituto Nacional de Salud, Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315388
- Sponsor's protocol ID
- 21-2021
- Status last verified
- Sep 2024
- First submitted
- 18 Mar 2022
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05315388
- Acronym / sponsor ID
- 21-2021
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Jeadran N. Malagón-RojasOther government
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Immersion therapy in nature - Vitamin NGroup with periodic outings to a neighborhood or metropolitan natural park (once a week) for approximately 2 hours for a minimum period of six months. |
| Group 2B: Vitamin N therapy group - forest forest environment | Experimental | Other: Immersion therapy in nature - Vitamin NGroup with periodic outings to a forest environment (once a week) for a time of approximately 2 hours for a minimum period of six months |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Persons over 18 years of age
- Health care workers
- Prioritized by the psychosocial risk program
- Complete vaccination schedule for COVID-19
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersion therapy in nature - Vitamin NAlso: Shinrin-yokuUsual 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 | Group 2A: Vitamin N therapy group - metropolitan park environment, Group 2B: Vitamin N therapy group - forest forest environment |
Primary outcome
Concentration of Cortisol in saliva
Time frame: 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.
Outcome Measures in Arterial pressure levels
Time frame: 4 time per month for 6 months
Blood pressure in mm Hg before and after surgery
Outcome Measures in Heart rate levels
Time frame: 4 time per month for 6 months
Determination by digital sphygmomanometers
Change Psychological stress measurement scale levels
Time frame: Three times for 6 months
Determination of a score of the level of occupational stress through different
4 secondary outcomes
Natural Killer
Time frame: 1 time per month for 6 months
Beck Anxiety Inventory levels
Time frame: Three times for 6 months
NR3C1 and FKBP5 gene methylation.
Time frame: Two times for 6 months
Pittsburgh Sleep Quality levels
Time frame: Three times for 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersion therapy in nature - Vitamin N in people with Cortisol Excess and Stress, Psychological, run by Jeadran N. Malagón-Rojas at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Cortisol in saliva (time frame: 1 time per month for 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.