HealthyNCT05384301
Effects of Urban Afforestation Activity on Mood, Stress, and Anxiety
A study testing Urban Afforestation Program in people with Healthy, run by Universidad de Granada at 1 site in Spain.
Trial summary
This single-group pretest-posttest clinical trial aims to evaluate the effects of a single-session afforestation activity on mood, stress, and anxiety in a sample of adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Urban Afforestation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSpain
- Study dates
- 25 May 2022to 5 Jun 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults between 18 and 65 years.
- Any sex and gender.
Who cannot join
- Intake of any psychotropic medication.
- Other severe or medically unstable diseases that may interfere with participation.
- Severe cognitive impairment (Mini-Mental State Examination score < 17 out of 30 points).
- Severe mental disorders in the acute phase or symptomatic phase.
- Severe intellectual disability.
- Behavioural alterations as this may interfere with their participation.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Granada, Faculty of Health Sciences
Granada, Andalusia, 18071
About this study
Official title: Effects of an Urban Afforestation Activity on Mood, Stress, and Anxiety of Adults
This single-group pretest-posttest clinical trial aims to evaluate the effects of a single-session afforestation activity on mood, stress, and anxiety in a sample of adults.
Read the detailed description
The participants will perform an afforestation activity for a single session of 90 minutes. The therapist will direct the participants' attention to the visual, auditory, olfactory, and tactile features of the surrounding environment.
- Conditions
- Healthy
- Being tested
- Urban Afforestation Program
- Keywords
- Green spaces, Nature-based activities, Urban afforestation, Horticultural therapy, Mental health, Mood, Stress, Anxiety
- Medical subject headings
- Psychological Well-Being, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urban Afforestation ProgramOther
Also called Nature-based activity, Afforestation activity
An afforestation program based on land cultivation and transplantation of several plants for 90 minutes will be implemented.
| Study group | Role | What they receive |
|---|---|---|
| Urban Afforestation Group | Experimental | Participants will perform an afforestation activity with a duration of 90 minutes. Receives: Other: Urban Afforestation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood
The Spanish adaptation of the 30-item Short Form of the Profile of Mood States will be utilised. There are five questions situated under each mood factor of Anger, Fatigue, Vigour, Friendliness, Tension, and Depressed Mood, which will be rated on a five-point scale starting from 0 indicating "not at all" up to 4 indicating "a lot" to evaluate the current feelings. Higher scores on the vigour and friendliness subscale indicate more positive mood, and higher scores on the remaining subscales indicate more negative mood.
Measured: Change from baseline the total mood disturbance after 90 minutes.
Secondary outcomes (2)
State stress
The perceived stress will be assessed by the 100-mm Visual Analogue Scale, where endpoints are labelled as "None" and "As bad as it could be" from left to right. The scale will yield a single quantitative variable regarded as the state stress score, which is measured by the distance between the far-left end and the participant's mark on the line in millimetres. Lower scores indicate less stress at the moment.
Measured: Change from baseline state stress after 90 minutes.
State anxiety
The 100-mm Visual Analogue Scale for state anxiety will be employed. The endpoints of the scale are labelled as "None" and "As bad as it could be" from left to right. The distance in millimetres between the far-left end and the participant's mark will be regarded as the state anxiety score. Lower scores indicate less anxiety at the moment.
Measured: Change from baseline state anxiety after 90 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start25 May 2022
- Primary completion5 Jun 2022
- Study completion5 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Manuel Pérez Mármol, Universidad de Granada
- Investigators
- José Manuel PÉREZ-MÁRMOL, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384301
- Sponsor's protocol ID
- AfforestMood
- Status last verified
- Jun 2022
- First submitted
- 17 May 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Urban Afforestation Activity on Mood, Stress, and Anxiety of Adults
- ClinicalTrials.gov ID
- NCT05384301
- Acronym / sponsor ID
- AfforestMood
- Conditions
- Healthy
- Keywords
- Green spaces, Nature-based activities, Urban afforestation, Horticultural therapy, Mental health, Mood, Stress, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 5 Jun 2022 (actual)
- First posted
- 20 May 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.
This single-group pretest-posttest clinical trial aims to evaluate the effects of a single-session afforestation activity on mood, stress, and anxiety in a sample of adults.
Detailed description
The participants will perform an afforestation activity for a single session of 90 minutes. The therapist will direct the participants' attention to the visual, auditory, olfactory, and tactile features of the surrounding environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urban Afforestation Group | Experimental | Other: Urban Afforestation ProgramParticipants will perform an afforestation activity with a duration of 90 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults between 18 and 65 years.
- Any sex and gender.
Key exclusion criteria (6 listed)
- Intake of any psychotropic medication.
- Other severe or medically unstable diseases that may interfere with participation.
- Severe cognitive impairment (Mini-Mental State Examination score < 17 out of 30 points).
- Severe mental disorders in the acute phase or symptomatic phase.
- Severe intellectual disability.
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 |
|---|---|---|
| Urban Afforestation ProgramAlso: Nature-based activity, Afforestation activityAn afforestation program based on land cultivation and transplantation of several plants for 90 minutes will be implemented. | Other | Urban Afforestation Group |
Primary outcome
Mood
Time frame: Change from baseline the total mood disturbance after 90 minutes.
The Spanish adaptation of the 30-item Short Form of the Profile of Mood States will be utilised. There are five questions situated under each mood factor of Anger, Fatigue, Vigour, Friendliness, Tension, and Depressed Mood, which will be rated on a five-point scale starting from 0 indicating "not at all" up to 4 indicating "a lot" to evaluate the current feelings. Higher scores on the vigour and friendliness subscale indicate more positive mood, and higher scores on the remaining subscales indicate more negative mood.
2 secondary outcomes
State stress
Time frame: Change from baseline state stress after 90 minutes.
State anxiety
Time frame: Change from baseline state anxiety after 90 minutes.
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 7 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
José Manuel PÉREZ-MÁRMOL, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urban Afforestation Program in people with Healthy, run by Universidad de Granada at 1 site in Spain.
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 2 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: finished, as of the sponsor's last update on 7 Jun 2022. 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 Spain. 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?
Mood (time frame: Change from baseline the total mood disturbance after 90 minutes.). 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 7 Jun 2022.