The aim of this study was to investigate the effect of landscape and planting design in improving children’s neuropsychological health in hospital environments.
Design
This study is a randomized non-blind clinical trial in which 60 persons including doctors, nurses and hospital workforce, and 120 persons, including the children and their parents, will randomly be selected; and 60 children hospitalized are randomly divided into two groups of intervention and control.
Settings and conduct
The site of the study is Akbar Children's Super Specialty Hospital. The research method is a questionnaire survey and interventional (semi-experimental) research.
Participants/Inclusion and exclusion criteria
Phase 1 and 3: All children aged in a range of 6 to 15 years old with their parents; and also, parents of the participant children must have at least completed their first year of primary school.
Phase 2: Only all physicians, nurses and personnel who work as staff members in the hospital are eligible to attend in this survey.
Intervention groups
Sick children who come to the Akbar Children's Super Specialty Hospital after sampling and checking the criteria for entering and leaving, register the patient's physical factors at the time of entering the hospital, then fill out a questionnaire, then, when the patient is discharged from the hospital and attending the rooms, the patient's physical factors will be recorded again and the questionnaire will be filled in.
The children of the experimental group are placed in pre-designed rooms with herbs for 3 days, and the control group children do not receive any interventions.
Main outcome variables
The neuropsychological health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180428039451N1
Registration date:2018-06-20, 1397/03/30
Registration timing:registered_while_recruiting
Last update:2018-06-20, 1397/03/30
Update count:0
Registration date
2018-06-20, 1397/03/30
Registrant information
Name
Maryam Allahyar
Name of organization / entity
The Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3880 5000
Email address
fatemeh.kazemi@um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-29, 1397/03/08
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of landscape and planting design in improving children’s neuropsychological health in hospital environments
Public title
Investigating the effect of landscape and planting design in improving children’s neuropsychological health in hospital environments
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Major conditions for entering into the first phase of the study based on Questionnaire No. 1:
All sick children should have an age ranged from 6 to 15 years old in Akbar Children's Super Specialty Hospital.
They must not be categorized in exceptional groups of children such as those with Intelligence Development Disabilities (IDD), and the Autism spectrum Children's Group and the group of children with anxiety and attention deficit disorders.
The parents of these children, must have the following characteristics:
1. Only the parents of the children with an age ranged from 6 to 15 years old will participate in the first questionnaire survey.
2. These parents must have completed at least grade 1 of the primary educational levels.
Major conditions for entering into the second phase of the study based on Questionnaire No. 2:
Only doctors, nurses and personnels who work in the workforce of Akbar Children's Super Specialty Hospital are included.
Major conditions for entering into the third phase of the study based on Questionnaire No. 3:
All parents of the children hospitalized in Akbar Children's Super Specialty Hospital are permitted to participate in this survey providing that:
1. Their child is in age range of 6 to 15 year.
2. They have completed at least grade 1 of the primary educational levels.
Exclusion criteria:
Major non-entry conditions include parents with an income less than $ 2 million tomans.
Those who are dependent to psychiatric and narcotic medicines.
Age
From 6 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
This research is a simple random method in which by inserting numbers on the paper, the rooms and beds belonging to the control group and the test group are randomly identified by the head nursing team. In the second step, the patient's children who come to the hospital take the paper containing their bed number and room number from inside a dish in which their bed and room number is inserted. The paper also states that the patient's bed and room are in the control group or the intervention group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Iran, Khorasan Razavi, Mashhad, University Street, Quraishi Building, Head of Department of Khorasan Razavi University of Medical Sciences and Health Services
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Approval date
2018-03-03, 1396/12/12
Ethics committee reference number
IR.MUMS.REC.1396.398
Health conditions studied
1
Description of health condition studied
The neuropsychological health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The neuropsychological health
Timepoint
For the third questionnaire, the measurements will be done first at the time of entering into the hospital, then at the time of discharge from the hospital and in fact after being hospitalized in the expected rooms. (It's worth noting that investigations in questionnaires 1 and 2 do not have limited measure periods).
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: includes the children admitted and hospitalized in Akbar Children's Super Specialty Hospital. In the first step, the opinions, needs and preferences of the user group (sick children) are evaluated using a questionnaire survey. Designing the questionnaire and the method of survey is adapted from Todorova et al.(2004). The method will be such that photomontages will first be provided as flash cards to the patient's child and the patients will be guided by the surveyor to complete his or her questionnaire based on the photos. In this research, photographs will be printed and provided to the respondent group (sick children).
Category
Rehabilitation
2
Description
The second intervention group: In the second step, in order to assess the preferences about the landscape of the hospital space and its impact on sick children based on the experts’ idea, a questionnaire will be adapted from Petros and Georgi (2011). This questionnaire will be available to the experts and will be carefully filled in by them.
Category
Rehabilitation
3
Description
The third intervention group: In the third step, the visual effect of green spaces on physical and neuropsychological improvement of two groups of sick children (group A:(experimental group) sick children in a room with natural plants and scenes that are not harmful to the patients; and group B: (control group) patient children in a room without natural plants will be assessed and compared in Akbar Children's Super Specialty Hospital. The method of the work will be to fill physical and neuropsychological state of the child by recording their physical factors which are approved by a specialist team, and then a questionnaire that has been approved by several specialists, will be filled at the admission time to the hospital. The same questionnaire will be filled by the patient children once the patient has been discharged from the hospital. The patient's physical factors will also be re-recorded when the patient is discharged from the hospital.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Children's Super Specialty Hospital
Full name of responsible person
Maryam Allahyar
Street address
In front of Shahid Kaveh 14, Shahid Kale boulevard, Akbar Children's Super Specialty Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 5000
Fax
Email
allahyar.maryam9@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad Ferdowsi University
Full name of responsible person
Dr. Ahmad Reza Bahrami
Street address
Faculty of Agriculture, Ferdowsi University of Mashhad, University of Pardis, Azadi Square, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 5000
Email
allahyar.maryam9@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad Ferdowsi University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Maryam Allahyar
Position
Student Master of Science in Horticulture and Greening Engineering
Latest degree
Bachelor
Other areas of specialty/work
Green space engineering
Street address
Faculty of Agriculture, Ferdowsi University of Mashhad, University of Pardis, Azadi Square, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 5000
Email
allahyar.maryam9@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Ferdowsi University
Full name of responsible person
Fatemeh Kazemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Green space engineering
Street address
Faculty of Agriculture, Ferdowsi University of Mashhad, University of Pardis, Azadi Square, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 5000
Email
fatemeh.kazemi@um.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Ferdowsi University
Full name of responsible person
Maryam Allahyar
Position
Student Master of Science in Horticulture and Greening Engineering
Latest degree
Bachelor
Other areas of specialty/work
Green space engineering
Street address
Faculty of Agriculture, Ferdowsi University of Mashhad, University of Pardis, Azadi Square, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 5000
Email
allahyar.maryam9@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available