HealthyNCT05364034
Effects of Urban Afforestation Activity on Pain Mechanisms
A study testing Urban Afforestation Intervention 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 pain thresholds. 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 Intervention Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSpain
- Study dates
- 16 May 2022to 24 May 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
- Free of pain in the hands, cheeks, lower back, wrists and trapezius muscles in the previous 3 months.
- Adults between 18 and 65 years.
- Any sex and gender.
Who cannot join
- Intake of any analgesic or 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.
- Pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Urban Afforestation Activity on Thermal and Mechanical Pain Mechanisms: a Clinical Trial
This single-group pretest-posttest clinical trial aims to evaluate the effects of a single-session afforestation activity on pain thresholds.
Read the detailed description
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. A battery of quantitative sensory tests pre- and post-intervention.
- Conditions
- Healthy
- Being tested
- Urban Afforestation Intervention Program
- Keywords
- Green spaces, Nature-based activities, Horticultural therapy, Quantitative sensory testing, Pain mechanisms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urban Afforestation Intervention ProgramOther
Also called Nature-based activity, Afforestation activity
An afforestation intervention 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 Intervention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold pain detection threshold
Cold pressor test will be employed (3±1°C). Participants will be instructed to submerge their nondominant hand in the cold water and report the initial occurrence of pain. Elapsed time in seconds will be recorded for the analysis as cold pain detection threshold. A cut-off time of 4 minutes is determined.
Measured: Change from baseline cold pain detection threshold after 90 minutes.
Cold pain tolerance threshold
Cold pressor test will be employed (3±1°C). Participants will be instructed to submerge their nondominant hand in the cold water as long as they can endure the pain. Elapsed time in seconds will be recorded for the analysis as cold pain tolerance threshold. A cut-off time of 4 minutes is determined.
Measured: Change from baseline cold pain tolerance threshold after 90 minutes.
Cold pain intensity ratings
Cold pressor test will be employed (3±1°C). Cold pain intensities will be measured by asking the participants to report their maximal pain intensities by using the 101-point Numeric Rating Scale once the cold detection and tolerance thresholds are reached.
Measured: Change from baseline cold pain intensity ratings after 90 minutes.
Wind-up ratio
A response-dependent mechanical temporal summation method will be implemented by utilising a pinprick mechanical stimulator (256 mN). A single stimulus will be applied to the L2-L5 paraspinal muscles of the nondominant side and the participant will be asked to rate the pain intensity on the 101-point Numeric Rating Scale. After an interval of 10 seconds, a train of 10 stimuli will be applied on the same point with a mean cadence of 2 stimuli per second. This time the participant will be asked to rate the overall intensity of pain evoked by the stimuli series. The pain rating of the stimuli series will be divided by that of the single punctuation. This value will be recorded as the wind-up ratio.
Measured: Change from baseline wind-up ratio after 90 minutes.
Mechanical pain sensitivity
The mechanical pain sensitivity of the participants' facial area will be assessed by using the same pinprick stimulator as for the wind-up ratio. A 2-sec pinprick stimulus will be applied on both cheeks three times. The interstimulus interval will be 10 seconds. Participants will be asked to rate the perceived pain intensity after each stimulus by using the 101-point Numeric Rating Scale. In case the participant does not report any pain, the minimum value of zero will be registered. A mean value of three measurements will be recorded as mechanical pain sensitivity.
Measured: Change from baseline mechanical pain sensitivity after 90 minutes.
Pressure pain detection thresholds
A hand-held dial pressure algometer device with the standard method of limits will be utilised. The application sites will consist of the muscle belly of the tibialis anterior and the middle of the dorsal aspect of the wrist joint line on the dominant side of participants. The patients will be asked to report the primary pain sensation to the evaluator. The value will be recorded in kg. A cut-off value of 1000 kPa is determined for safety reasons. A total of three measurements will be obtained at each site. Average of the second and third measurements will be recorded as pressure pain detection threshold.
Measured: Change from baseline pressure pain detection threshold after 90 minutes.
Pressure pain intensity ratings
The same instrument as in the pressure pain detection thresholds will be utilised. This time, nail of the dominant thumb will be subjected to two separate pressure levels, 294 kPa and 490 kPa, to obtain pressure pain intensity ratings. Upon reaching the aimed level, the pressure will be maintained for 2 seconds. Thereafter, participants will be asked to rate the evoked pain sensation by using the 101-point Numeric Rating Scale. Those who are unable to tolerate these pressure levels will be excluded from the analysis and handled as missing data. This procedure will be repeated three times. The average of the second and third measurements will be recorded as pressure pain ratings.
Measured: Change from baseline pressure pain intensity ratings after 90 minutes.
Pressure pain tolerance thresholds
The maximum pressure at which the participant defines the ongoing pain as intolerable is defined as the pressure pain tolerance threshold. A similar procedure as the detection thresholds will be adapted and followed this time for the mid-point of the upper border of the trapezius muscle and the nail cuticle of the ring finger on the nondominant side of participants. Average of the second and third measurements will be recorded as pressure pain tolerance threshold.
Measured: Change from baseline pressure pain tolerance threshold 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 posted6 May 2022
- Study start16 May 2022
- Primary completion24 May 2022
- Study completion24 May 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
- 47 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
- NCT05364034
- Sponsor's protocol ID
- AfforestPain
- Status last verified
- May 2022
- First submitted
- 3 May 2022
- Last updated
- 25 May 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 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Urban Afforestation Activity on Thermal and Mechanical Pain Mechanisms: a Clinical Trial
- ClinicalTrials.gov ID
- NCT05364034
- Acronym / sponsor ID
- AfforestPain
- Conditions
- Healthy
- Keywords
- Green spaces, Nature-based activities, Horticultural therapy, Quantitative sensory testing, Pain mechanisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 6 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 pain thresholds.
Detailed description
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. A battery of quantitative sensory tests pre- and post-intervention.
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 Intervention 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 (3 listed)
- Free of pain in the hands, cheeks, lower back, wrists and trapezius muscles in the previous 3 months.
- Adults between 18 and 65 years.
- Any sex and gender.
Key exclusion criteria (7 listed)
- Intake of any analgesic or 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 Intervention ProgramAlso: Nature-based activity, Afforestation activityAn afforestation intervention program based on land cultivation and transplantation of several plants for 90 minutes will be implemented. | Other | Urban Afforestation Group |
Primary outcome
Cold pain detection threshold
Time frame: Change from baseline cold pain detection threshold after 90 minutes.
Cold pressor test will be employed (3±1°C). Participants will be instructed to submerge their nondominant hand in the cold water and report the initial occurrence of pain. Elapsed time in seconds will be recorded for the analysis as cold pain detection threshold. A cut-off time of 4 minutes is determined.
Cold pain tolerance threshold
Time frame: Change from baseline cold pain tolerance threshold after 90 minutes.
Cold pressor test will be employed (3±1°C). Participants will be instructed to submerge their nondominant hand in the cold water as long as they can endure the pain. Elapsed time in seconds will be recorded for the analysis as cold pain tolerance threshold. A cut-off time of 4 minutes is determined.
Cold pain intensity ratings
Time frame: Change from baseline cold pain intensity ratings after 90 minutes.
Cold pressor test will be employed (3±1°C). Cold pain intensities will be measured by asking the participants to report their maximal pain intensities by using the 101-point Numeric Rating Scale once the cold detection and tolerance thresholds are reached.
Wind-up ratio
Time frame: Change from baseline wind-up ratio after 90 minutes.
A response-dependent mechanical temporal summation method will be implemented by utilising a pinprick mechanical stimulator (256 mN). A single stimulus will be applied to the L2-L5 paraspinal muscles of the nondominant side and the participant will be asked to rate the pain intensity on the 101-point Numeric Rating Scale. After an interval of 10 seconds, a train of 10 stimuli will be applied on the same point with a mean cadence of 2 stimuli per second. This time the participant will be asked to rate the overall intensity of pain evoked by the stimuli series. The pain rating of the stimuli series will be divided by that of the single punctuation. This value will be recorded as the wind-up ratio.
Mechanical pain sensitivity
Time frame: Change from baseline mechanical pain sensitivity after 90 minutes.
The mechanical pain sensitivity of the participants' facial area will be assessed by using the same pinprick stimulator as for the wind-up ratio. A 2-sec pinprick stimulus will be applied on both cheeks three times. The interstimulus interval will be 10 seconds. Participants will be asked to rate the perceived pain intensity after each stimulus by using the 101-point Numeric Rating Scale. In case the participant does not report any pain, the minimum value of zero will be registered. A mean value of three measurements will be recorded as mechanical pain sensitivity.
Pressure pain detection thresholds
Time frame: Change from baseline pressure pain detection threshold after 90 minutes.
A hand-held dial pressure algometer device with the standard method of limits will be utilised. The application sites will consist of the muscle belly of the tibialis anterior and the middle of the dorsal aspect of the wrist joint line on the dominant side of participants. The patients will be asked to report the primary pain sensation to the evaluator. The value will be recorded in kg. A cut-off value of 1000 kPa is determined for safety reasons. A total of three measurements will be obtained at each site. Average of the second and third measurements will be recorded as pressure pain detection threshold.
Pressure pain intensity ratings
Time frame: Change from baseline pressure pain intensity ratings after 90 minutes.
The same instrument as in the pressure pain detection thresholds will be utilised. This time, nail of the dominant thumb will be subjected to two separate pressure levels, 294 kPa and 490 kPa, to obtain pressure pain intensity ratings. Upon reaching the aimed level, the pressure will be maintained for 2 seconds. Thereafter, participants will be asked to rate the evoked pain sensation by using the 101-point Numeric Rating Scale. Those who are unable to tolerate these pressure levels will be excluded from the analysis and handled as missing data. This procedure will be repeated three times. The average of the second and third measurements will be recorded as pressure pain ratings.
Pressure pain tolerance thresholds
Time frame: Change from baseline pressure pain tolerance threshold after 90 minutes.
The maximum pressure at which the participant defines the ongoing pain as intolerable is defined as the pressure pain tolerance threshold. A similar procedure as the detection thresholds will be adapted and followed this time for the mid-point of the upper border of the trapezius muscle and the nail cuticle of the ring finger on the nondominant side of participants. Average of the second and third measurements will be recorded as pressure pain tolerance threshold.
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 25 May 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.
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 Intervention 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 3 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 25 May 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?
Cold pain detection threshold (time frame: Change from baseline cold pain detection threshold after 90 minutes.). The study lists 8 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 25 May 2022.