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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Spain
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Urban Afforestation Group
Participants will perform an afforestation activity with a duration of 90 minutes.
Other: Urban Afforestation Intervention Program
An afforestation intervention program based on land cultivation and transplantation of several plants for 90 minutes will be implemented.
Other Names:
  • Nature-based activity
  • Afforestation activity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Granada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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