Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04742179
Other study ID # 11/2020
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 11, 2022
Est. completion date May 11, 2022

Study information

Verified date December 2022
Source Istituto per la Ricerca e l'Innovazione Biomedica
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, non-randomized, controlled, interventional study aiming to assess, in a primary school in the city of Palermo, the health effects of a maintenance and care intervention of the school's green areas. All children of the third, fourth and fifth classes of two school complexes of the same primary school will be selected. One complex will undergo maintenance and care of the green areas and gardens inside the school. The other complex will serve as a control group and will not undergo any intervention. The study will involve three phases. 1. During the first phase (prior to the intervention) respiratory and allergic symptoms will be assessed through a standardized questionnaire to be administered to students, parents and teachers in both the school complexes. 2. During the second phase, the maintenance and care intervention plan will be implemented in the experimental complex. 3. During the third phase, 1 week after the maintenance intervention, respiratory and allergic symptoms will be re-assessed through a standardized questionnaire to be administered to the same students, parents and teachers in both the school complexes.


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date May 11, 2022
Est. primary completion date May 11, 2022
Accepts healthy volunteers No
Gender All
Age group 7 Years to 11 Years
Eligibility Inclusion Criteria: - male or female gender - age between 7 and 11 years Exclusion Criteria: - no exclusion criteria

Study Design


Related Conditions & MeSH terms

  • Respiratory and Allergic Symptoms

Intervention

Other:
Manteinance and care intervention on the green areas.
Manteinance and care intervention on the green areas.

Locations

Country Name City State
Italy Institute of Translational Pharmacology Palermo

Sponsors (1)

Lead Sponsor Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Asthma symptoms at baseline Presence of asthma symptoms before the maintenance intervention Before the maintenance intervention
Primary Rhinitis symptoms at baseline Presence of rhinitis symptoms before the maintenance intervention Before the maintenance intervention
Primary Conjunctivitis symptoms at baseline Presence of conjunctivitis symptoms before the maintenance intervention Before the maintenance intervention
Primary Asthma symptoms at follow-up Presence of asthma symptoms after the maintenance intervention 7 days after the maintenance intervention
Primary Rhinitis symptoms at follow-up Presence of rhinitis symptoms after the maintenance intervention 7 days after the maintenance intervention
Primary Conjunctivitis symptoms at follow-up Presence of conjunctivitis symptoms after the maintenance intervention 7 days after the maintenance intervention