AnxietyNCT03266120
Health Benefits of Gardening
A study testing Art and Gardening in people with Anxiety and Depression, run by University of Florida at 2 sites in United States.
Trial summary
The objective of the research is to test the hypothesis that participating in group-based gardening or group-based art activities may alter the mental health and cardiac physiological status of a wellness population of women ages 26-49. Read more about this study
- Who is it for?
- Ages 26 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Healthy
- What is being tested?
- Art and Gardening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Aug 2017to 15 Jan 2018
- 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 26 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal women
- 26 - 49 years of age
- Not pregnant
- Non-gardener
- Non-artist
- Non-smoker
- Good Health
- Able to participate in all aspects of the study, including working with plants.
Who cannot join
- Uncomfortable in close spaces (claustrophobia)
- Allergies to plants
- Allergies to plant parts like pollen
- Allergies to plant-based foods
- No additions to alcohol or to recreational drugs or prescription medications
- Not suffering from recurring pain, and
- No diseases, disorders or disabilities that affect daily life.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fifield and Merhof Halls
Gainesville, Florida, 32611
Wilmot Gardens Conference Center and Greenhouse
Gainesville, Florida, 32611
About this study
Official title: Assessing Human Health Benefits of Gardening
The objective of the research is to test the hypothesis that participating in group-based gardening or group-based art activities may alter the mental health and cardiac physiological status of a wellness population of women ages 26-49. Assessment of the effects of gardening or art activities on the experimental population will take two approaches, the first being the use of physiological measurements of heart rate and blood pressure. The second approach will employ six widely used and well-established self-reported assessment instruments that will capture information about the health and well-being of participants. These measurements and assessments will provide a psychometrically-based before and after mental health status and between treatments health summaries of the participants in the gardening group and those engaged in the art group activities.
Read the detailed description
The goal of this project is to better understand how interacting and working with plants in a group gardening activities program in a greenhouse, or a group art program that takes place indoors and is devoid of images or depictions of plants influences the overall health and well-being of participants.
A total anticipated study population (N = 40) will consist of up to 20 healthy women randomly assigned to the art activities group, and up to 20 healthy women assigned to the gardening group. There will be measurements of heart rate, systolic and diastolic blood pressure, and psychometric assessments including satisfaction of social activities at baseline and post intervention. Heart rate and blood pressure measurements will be taken at the beginning and end of each of the eight gardening or arts sessions. Psychometric assessments of study participants will be conducted at baseline and post-intervention. Each treatment group will be divided into two smaller groups of up to ten women each that will receive the gardening or art interventions on different days of the week. The participants in the gardening or art groups will receive an experimental intervention consisting of 8 gardening or art sessions, each approximately 60 minutes in duration over a four week treatment period. Gardening and art sessions will take place at the same time of day twice each week, and follow a standardized programming sequence to ensure equivalency of intervention across all sessions. Ambient environmental conditions in the greenhouse during the gardening sessions will be monitored and recorded. The gardening activities will emphasize growing plants from seeds, plant propagation techniques, transplanting, and plant-mediated taste, visual, olfactory and touch sensory stimulation. All gardening sessions will begin with a short educational module introducing the plants and gardening activities taking place during each session. Art activities will include papermaking, image transfer, visual storytelling, linocut printmaking, paper batik, mixed media collage, and sensation drawing, and begin with a short educational module of the activity.
In addition to the pre- and post-intervention assessments and measurement, psychometric assessments will be administered for depression symptomatology, mood states and perceived stress at specific points during the gardening and art activities to evaluate any changes over time resulting from the interventions. Participant heart rate and blood pressure measurements will be made at the beginning and at the end of all gardening and art sessions.
- Conditions
- Anxiety, Depression, Healthy, Mood Disturbance, Stress, Quality of Life
- Being tested
- Art, Gardening
- Keywords
- Gardening, Therapeutic Arts, Therapeutic Horticulture, Anxiety, Depression, Mood States, Quality of Life, Social Interactions, Stress, Wellness
- Medical subject headings
- Anxiety Disorders, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtOther
Participants will receive a hands-on art activities intervention consisting of two art activities sessions each week lasting approximately 60 minutes each in duration for four weeks for a total of eight sessions. Art activities will include hand papermaking, image transfer, visual storytelling, linocut printmaking, paper batik, mixed media collage, and sensation drawing based activities. Participants will complete sets of self-report psychometric assessments before, during, and following the art intervention. Heart rate and blood pressure will be monitored before, during, and following completion of the art intervention.
GardeningOther
Also called Horticulture, People-Plant Interactions
Participants will receive a hands-on gardening intervention consisting of two gardening sessions each week lasting approximately 60 minutes each in duration for four weeks, for a total of eight sessions. Gardening activities will include planting seeds, bulbs and tubers, transplanting seedlings, vegetative propagation and sight, smell, taste and touch sensory based activities. Participants will complete sets of self-report psychometric assessments before, during, and following the gardening intervention. Heart rate and blood pressure will be monitored before, during, and following completion of the gardening intervention.
| Study group | Role | What they receive |
|---|---|---|
| Art Intervention | Active comparator | Participants randomly assigned to this arm will receive a hands-on art intervention that will consist of twice weekly group sessions of approximately 60 minutes each in duration that will take place indoors over a period of four weeks for a total of eight art sessions. Participants will complete sets of self-report psychometric assessments and blood pressure and heart rate will be monitored before, during, and following the conclusion of the intervention. Receives: Other: Art |
| Gardening Intervention | Experimental | Participants randomly assigned to this arm will receive a hands-on gardening intervention that will consist of twice weekly group sessions of approximately 60 minutes each in duration that will take place in a greenhouse over a period of four weeks for a total of eight gardening sessions. Participants will complete sets of self-report psychometric assessments and blood pressure and heart rate will be monitored before, during, and following the conclusion of the intervention. Receives: Other: Gardening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biometric Changes in Heart Rate
Heart rate will be monitored using a portable electronic wrist cuff monitor. Participant heart rate will be measured at the beginning and end of each Individual treatment session, and before the beginning and after the completion of the entire treatment interventions.
Measured: Baseline, up to 5 weeks
Biometric Changes in Blood Pressure
Blood pressure will be monitored using a portable electronic wrist cuff blood pressure monitor that records systolic and diastolic pressure. Participant blood pressure measurements will be recorded before and after each individual treatment session, and before the beginning and after the completion of the entire treatment interventions.
Measured: Baseline, up to 5 weeks
Secondary outcomes (6)
Biometric Changes in Overall Health Status
The SF-36v2 Health Survey assessment instrument (Ware and Sherbourne 1992; Hays et al 1993) will be used to evaluate eight scales that link to physical and mental health over a 4-week recall interval. This will reveal whether engaging in gardening activities will or will not result in changes in the overall health status based on instrument's physical and mental health subcomponent assessments of the gardening treatment group compared to the control group. The overall assessment scale for the SF-36 ranges from a low of 36 to a high of 400, with the U.S. norm being 314.
Measured: Baseline, up to 5 weeks
Biometric Changes in Depressive Symptomatology
The study protocol will use the Beck Depression Inventory 2nd edition (BDI-II) (Beck et al 1988) with a recall interval of 2-weeks to gain insight relative to the intensity of depression. This assessment will determine whether engaging in gardening will or will not result in changes in depressive symptomatology of the gardening treatment group relative to the control group. The assessment scale for the Beck BDI ranges from a low of 10 to a high of 63. Scores 0-13 indicate minimal depressive symptomatology and above 19 up to 63 moderate to severe depressive symptomatology.
Measured: Baseline, up to 5 weeks
Biometric Changes in State Anxiety
The State Trait Anxiety Inventory (STAI) instrument (Form Y) (Spielberger et al 1983) will be used in this study to gain insight regarding the relative intensity of anxiety being experienced by the gardening treatment group relative to the control group. The STAI reports on "at this moment" status. The STAI assessment will seek to determine whether engaging in gardening will or will not result in changes in State Anxiety status of the participants. The overall assessment scale for the STAI-Y ranges from a low of 20 to a high of 80, with higher scores indicating greater intensity of anxiety.
Measured: Baseline, up to 5 weeks
Biometric Changes in Mood States
The study protocol will employ the Profile of Mood States 2nd edition short form for adults instrument (POMS2-AS) with an immediate recall interval (McNair et al 1981; Shacham 1983) to gain insight of the relative to transient and fluctuating moods and enduring states of affect. The POMS2-AS will assess whether engaging in gardening activities will or will not result in changes in mood and enduring states of affect status of the gardening treatment group relative to the control group, both during and following the completion of the gardening activities treatment regimen. The assessment scale for the POMS2-AS ranges from 5 to a high of 100 per scale .
Measured: Baseline, up to 5 weeks
Biometric Changes in Perceived Stress
The study will use the Perceived Stress Scale (PSS) (Cohen et al 1983) with a recall interval of 4-weeks to gain insight relative to the intensity of perceived stress. This assessment will determine whether engaging in gardening activities will or will not result in changes in the perceived stress levels of the gardening treatment group relative to the control group. The assessment scale for the Perceived Stress Scale ranges from a low of 0 to a high of 40, indicating higher stress at higher scores. The norm score for women is 13.7.
Measured: Baseline, up to 5 weeks
Biometric Changes in Satisfaction in Social Activities
The study will use the The Satisfaction with Participation in Discretionary Social Activities (SPDSA) PROMIS short form v1.0 instrument to assess contentment with participants' leisure time and affairs with friends, and encompasses a recall interval of one week (Hahn et al 2010)
Measured: Baseline, up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start3 Aug 2017
- Primary completion9 Nov 2017
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles L Guy, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266120
- Sponsor's protocol ID
- IRB201701647
- Status last verified
- Jun 2018
- First submitted
- 24 Aug 2017
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305.
PubMed 8275167Beck, AT, Steer RA, Garbin MG. Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical Psychology Review 1988 (8):77-100.
Spielberger, CD, Gorsuch RL, Lushene R. The State-Trait Personality Inventory STAI-Y, form Y. Consulting Psychologists Press, Palo Alto. 1983
McNair PM, Lorr M, Droppleman LF. POMS manual (2nd ed.). San Diego: Educational and Industrial Testing Service. 1981.
Shacham S. A shortened version of the Profile of Mood States. J Pers Assess. 1983 Jun;47(3):305-6. doi: 10.1207/s15327752jpa4703_14.
PubMed 6886962Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Hahn EA, Beaumont JL, Pilkonis PA, Garcia SF, Magasi S, DeWalt DA, Cella D. The PROMIS satisfaction with social participation measures demonstrated responsiveness in diverse clinical populations. J Clin Epidemiol. 2016 May;73:135-41. doi: 10.1016/j.jclinepi.2015.08.034. Epub 2016 Feb 27.
PubMed 26931288Odeh R, Diehl ERM, Nixon SJ, Tisher CC, Klempner D, Sonke JK, Colquhoun TA, Li Q, Espinosa M, Perdomo D, Rosario K, Terzi H, Guy CL. A pilot randomized controlled trial of group-based indoor gardening and art activities demonstrates therapeutic benefits to healthy women. PLoS One. 2022 Jul 6;17(7):e0269248. doi: 10.1371/journal.pone.0269248. eCollection 2022.
PubMed 35793277
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Human Health Benefits of Gardening
- ClinicalTrials.gov ID
- NCT03266120
- Acronym / sponsor ID
- IRB201701647
- Conditions
- Anxiety, Depression, Healthy, Mood Disturbance, Stress, Quality of Life
- Keywords
- Gardening, Therapeutic Arts, Therapeutic Horticulture, Anxiety, Depression, Mood States, Quality of Life, Social Interactions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 9 Nov 2017 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 29 Aug 2017 (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.
The objective of the research is to test the hypothesis that participating in group-based gardening or group-based art activities may alter the mental health and cardiac physiological status of a wellness population of women ages 26-49. Assessment of the effects of gardening or art activities on the experimental population will take two approaches, the first being the use of physiological measurements of heart rate and blood pressure. The second approach will employ six widely used and well-established self-reported assessment instruments that will capture information about the health and well-being of participants. These measurements and assessments will provide a psychometrically-based before and after mental health status and between treatments health summaries of the participants in the gardening group and those engaged in the art group activities.
Detailed description
The goal of this project is to better understand how interacting and working with plants in a group gardening activities program in a greenhouse, or a group art program that takes place indoors and is devoid of images or depictions of plants influences the overall health and well-being of participants.
A total anticipated study population (N = 40) will consist of up to 20 healthy women randomly assigned to the art activities group, and up to 20 healthy women assigned to the gardening group. There will be measurements of heart rate, systolic and diastolic blood pressure, and psychometric assessments including satisfaction of social activities at baseline and post intervention. Heart rate and blood pressure measurements will be taken at the beginning and end of each of the eight gardening or arts sessions. Psychometric assessments of study participants will be conducted at baseline and post-intervention. Each treatment group will be divided into two smaller groups of up to ten women each that will receive the gardening or art interventions on different days of the week. The participants in the gardening or art groups will receive an experimental intervention consisting of 8 gardening or art sessions, each approximately 60 minutes in duration over a four week treatment period. Gardening and art sessions will take place at the same time of day twice each week, and follow a standardized programming sequence to ensure equivalency of intervention across all sessions. Ambient environmental conditions in the greenhouse during the gardening sessions will be monitored and recorded. The gardening activities will emphasize growing plants from seeds, plant propagation techniques, transplanting, and plant-mediated taste, visual, olfactory and touch sensory stimulation. All gardening sessions will begin with a short educational module introducing the plants and gardening activities taking place during each session. Art activities will include papermaking, image transfer, visual storytelling, linocut printmaking, paper batik, mixed media collage, and sensation drawing, and begin with a short educational module of the activity.
In addition to the pre- and post-intervention assessments and measurement, psychometric assessments will be administered for depression symptomatology, mood states and perceived stress at specific points during the gardening and art activities to evaluate any changes over time resulting from the interventions. Participant heart rate and blood pressure measurements will be made at the beginning and at the end of all gardening and art sessions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Art Intervention | Active comparator | Other: ArtParticipants randomly assigned to this arm will receive a hands-on art intervention that will consist of twice weekly group sessions of approximately 60 minutes each in duration that will take place indoors over a period of four weeks for a total of eight art sessions. Participants will complete sets of self-report psychometric assessments and blood pressure and heart rate will be monitored before, during, and following the conclusion of the intervention. |
| Gardening Intervention | Experimental | Other: GardeningParticipants randomly assigned to this arm will receive a hands-on gardening intervention that will consist of twice weekly group sessions of approximately 60 minutes each in duration that will take place in a greenhouse over a period of four weeks for a total of eight gardening sessions. Participants will complete sets of self-report psychometric assessments and blood pressure and heart rate will be monitored before, during, and following the conclusion of the intervention. |
Who may qualify
- Ages
- 26 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Premenopausal women
- 26 - 49 years of age
- Not pregnant
- Non-gardener
- Non-artist
Key exclusion criteria (7 listed)
- Uncomfortable in close spaces (claustrophobia)
- Allergies to plants
- Allergies to plant parts like pollen
- Allergies to plant-based foods
- No additions to alcohol or to recreational drugs or prescription medications
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 |
|---|---|---|
| ArtParticipants will receive a hands-on art activities intervention consisting of two art activities sessions each week lasting approximately 60 minutes each in duration for four weeks for a total of eight sessions. Art activities will include hand papermaking, image transfer, visual storytelling, linocut printmaking, paper batik, mixed media collage, and sensation drawing based activities. Participants will complete sets of self-report psychometric assessments before, during, and following the art intervention. Heart rate and blood pressure will be monitored before, during, and following completion of the art intervention. | Other | Art Intervention |
| GardeningAlso: Horticulture, People-Plant InteractionsParticipants will receive a hands-on gardening intervention consisting of two gardening sessions each week lasting approximately 60 minutes each in duration for four weeks, for a total of eight sessions. Gardening activities will include planting seeds, bulbs and tubers, transplanting seedlings, vegetative propagation and sight, smell, taste and touch sensory based activities. Participants will complete sets of self-report psychometric assessments before, during, and following the gardening intervention. Heart rate and blood pressure will be monitored before, during, and following completion of the gardening intervention. | Other | Gardening Intervention |
Primary outcome
Biometric Changes in Heart Rate
Time frame: Baseline, up to 5 weeks
Heart rate will be monitored using a portable electronic wrist cuff monitor. Participant heart rate will be measured at the beginning and end of each Individual treatment session, and before the beginning and after the completion of the entire treatment interventions.
Biometric Changes in Blood Pressure
Time frame: Baseline, up to 5 weeks
Blood pressure will be monitored using a portable electronic wrist cuff blood pressure monitor that records systolic and diastolic pressure. Participant blood pressure measurements will be recorded before and after each individual treatment session, and before the beginning and after the completion of the entire treatment interventions.
6 secondary outcomes
Biometric Changes in Overall Health Status
Time frame: Baseline, up to 5 weeks
Biometric Changes in Depressive Symptomatology
Time frame: Baseline, up to 5 weeks
Biometric Changes in State Anxiety
Time frame: Baseline, up to 5 weeks
Biometric Changes in Mood States
Time frame: Baseline, up to 5 weeks
Biometric Changes in Perceived Stress
Time frame: Baseline, up to 5 weeks
Biometric Changes in Satisfaction in Social Activities
Time frame: Baseline, up to 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Background: PubMed 1593914Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Background: PubMed 8275167Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305.
- BackgroundBeck, AT, Steer RA, Garbin MG. Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical Psychology Review 1988 (8):77-100.
- BackgroundSpielberger, CD, Gorsuch RL, Lushene R. The State-Trait Personality Inventory STAI-Y, form Y. Consulting Psychologists Press, Palo Alto. 1983
- BackgroundMcNair PM, Lorr M, Droppleman LF. POMS manual (2nd ed.). San Diego: Educational and Industrial Testing Service. 1981.
- Background: PubMed 6886962Shacham S. A shortened version of the Profile of Mood States. J Pers Assess. 1983 Jun;47(3):305-6. doi: 10.1207/s15327752jpa4703_14.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 26931288Hahn EA, Beaumont JL, Pilkonis PA, Garcia SF, Magasi S, DeWalt DA, Cella D. The PROMIS satisfaction with social participation measures demonstrated responsiveness in diverse clinical populations. J Clin Epidemiol. 2016 May;73:135-41. doi: 10.1016/j.jclinepi.2015.08.034. Epub 2016 Feb 27.
- Derived from this study: PubMed 35793277Odeh R, Diehl ERM, Nixon SJ, Tisher CC, Klempner D, Sonke JK, Colquhoun TA, Li Q, Espinosa M, Perdomo D, Rosario K, Terzi H, Guy CL. A pilot randomized controlled trial of group-based indoor gardening and art activities demonstrates therapeutic benefits to healthy women. PLoS One. 2022 Jul 6;17(7):e0269248. doi: 10.1371/journal.pone.0269248. eCollection 2022.
- 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.
Charles L Guy, PhD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art and Gardening in people with Anxiety and Depression, run by University of Florida at 2 sites in United States.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biometric Changes in Heart Rate (time frame: Baseline, up to 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03266120, which also lists 9 linked publications.
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 6 Jun 2018.