- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05364034
Effects of Urban Afforestation Activity on Pain Mechanisms
May 24, 2022 updated by: José Manuel Pérez Mármol, Universidad de Granada
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Granada, Spain, 18071
- University of Granada, Faculty of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Urban Afforestation Group
Participants will perform an afforestation activity with a duration of 90 minutes.
|
An afforestation intervention program based on land cultivation and transplantation of several plants for 90 minutes will be implemented.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Change from baseline cold pain detection threshold after 90 minutes.
|
|
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.
|
Change from baseline cold pain tolerance threshold after 90 minutes.
|
|
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.
|
Change from baseline cold pain intensity ratings after 90 minutes.
|
|
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.
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Change from baseline wind-up ratio after 90 minutes.
|
|
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.
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Change from baseline mechanical pain sensitivity after 90 minutes.
|
|
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.
|
Change from baseline pressure pain detection threshold after 90 minutes.
|
|
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.
|
Change from baseline pressure pain intensity ratings after 90 minutes.
|
|
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.
|
Change from baseline pressure pain tolerance threshold after 90 minutes.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: José Manuel PÉREZ-MÁRMOL, PhD, Associate Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 16, 2022
Primary Completion (Actual)
May 24, 2022
Study Completion (Actual)
May 24, 2022
Study Registration Dates
First Submitted
May 3, 2022
First Submitted That Met QC Criteria
May 3, 2022
First Posted (Actual)
May 6, 2022
Study Record Updates
Last Update Posted (Actual)
May 25, 2022
Last Update Submitted That Met QC Criteria
May 24, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AfforestPain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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