Protocol summary

Study aim
Investigation of the effect of indoor air pollution prevention protocol on the occurrence of symptoms of sick building syndrome and maintaining balance, sleep quality among older population of Shiraz city
Design
Randomized clinical trial using Efron's equal block randomization method, as a blind strain, the sample size was obtained using NCSS-PASS version 15 software, 112 people, which were equally divided into 2 groups (intervention and control).
Settings and conduct
Training classes and completion of questionnaires are conducted in the Farzangan Shiraz Foundation with the presence of the presenter and clinic manager.Blinding of participants occurs in such a way that they are unaware of the study group allocation and all participants involved in the study assume that all participants have received the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age requirements (60-74 years)؛ Residence being an apartment؛ Willingness to participate in the study؛ Living in the current home for at least one month؛ Being at home for at least 8 hours a day؛ Be covered by Farzangan Foundation of Shiraz؛ Answer positively to at least one of the questions in the patient's building syndrome symptoms section؛ Exclusion criteria: Reluctance to continue cooperation؛ older adult death؛ Residence being a villa؛ Moving the older adult to a new place
Intervention groups
The elderly were divided into two intervention and control groups, and for the intervention group, classes will be held to teach the indoor air prevention protocol. The control group does not receive training.
Main outcome variables
Sick building syndrome; Maintaining balance; Sleep quality; Cognitive status.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180514039648N7
Registration date: 2024-05-18, 1403/02/29
Registration timing: retrospective

Last update: 2024-05-18, 1403/02/29
Update count: 0
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
Abdolrahim Asadollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1001
Email address
a_asadollahi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-14, 1402/10/24
Expected recruitment end date
2024-04-12, 1403/01/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of indoor air pollution prevention protocol on the occurrence of symptoms of sick building syndrome and maintaining balance, sleep quality among older population: a randomized controlled trial
Public title
The effect of indoor air pollution prevention protocol on the occurrence of symptoms of sick building syndrome and maintaining balance, sleep quality among elderly people
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age requirements (60-74 years) Residence being an apartment Willingness to participate in the study Living in the current home for at least one month Being at home for at least 8 hours a day Be covered by Farzangan Foundation of Shiraz Answer positively to at least one of the questions in the patient's building syndrome symptoms section.
Exclusion criteria:
Reluctance to continue cooperation. Older adult death Residence being a villa Moving the older adult to a new place
Age
From 60 years old to 74 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 112
Randomization (investigator's opinion)
Randomized
Randomization description
For sampling, the study samples are randomly divided into different intervention and control groups. In this type of trials, a group of people who are members of Farzangan Foundation of Shiraz and have entry criteria will be selected (random allocation). In each care center for the elderly, there is a list of names of members in the center with a membership code, and each number will be defined with an identification number in the software. 200 members of Shiraz chose to become members of Farzangan Foundation and the patient's building syndrome can be evaluated using the checklist, and 112 people who meet all the conditions for entering the study are selected and randomized using the sampling technique. With Efron's method of equal blocks with the help of PASS software version 15 (2021), the classification is done in a way that classifies these 112 people into 2 equal blocks in each block (56 people) by determining 500 repetitions (repetition of search) between groups and the final sample will be set.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding occurs in participants in such a way that they are unaware of the study group allocation and all participants involved in the study assume that all participants have received the intervention.
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
School of Health, Razi Boulevard
City
Shiraz
Province
Fars
Postal code
7153675541
Approval date
2023-12-03, 1402/09/12
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1402.125

Health conditions studied

1

Description of health condition studied
Sick building syndrome
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Insomnia and sleep quality
ICD-10 code
G47.0
ICD-10 code description
Insomnia

Primary outcomes

1

Description
Sick building syndrome
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Sick building syndrome checklist

2

Description
Balance
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Berg balance test

3

Description
sleep quality
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Insomnia Severity Index questionnaire (ISI)

4

Description
Cognitive status
Timepoint
Before the intervention and two months after the intervention
Method of measurement
The Mini-Addenbrooke's Cognitive Examination (Mini-ACE)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 6 one-hour training sessions will be held for the intervention group (56 older adult) with the aim of getting to know the building syndrome and the indoor air patient, as well as training the indoor air protocol. In the intervention group, BBS, Mini-ACE and ISI questionnaires and behavioral checklist will be completed before the intervention and 2 months after the end of the intervention.
Category
Prevention

2

Description
Control group: No intervention will be performed for the control group. In the control group, BBS, Mini-ACE and ISI questionnaires and behavioral checklist will be completed before the intervention and 2 months after the intervention. According to ethical considerations, after the end of the intervention, the training given to the experimental group will also be given to the control group. Also, the pamphlets distributed in the training sessions will be provided to them.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
FDCF of Shiraz
Full name of responsible person
Dr.Abdolrahim Asadollahi
Street address
No. 30, in front of Alavi Park, Mirzaye Shirazi Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 912 249 8890
Email
a_asadollahi@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempour
Street address
Research and Technology Deputy, 7th Floor, Shiraz University of Medical Sciences Central Building, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Fax
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz University Of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Negar Paydar Jahromi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
School of Health, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
00987137251001-10
Email
a_asadollahi@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Abdolrahim Asadollahi
Position
Academic member
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
School of Health, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
00987137251001-10
Email
a_asadollahi@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Negar Paydar Jahromi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
School of health, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
00987137251001-10
Email
a_asadollahi@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data file will be shared in Mendeley's database in the form of spss software version 25.
When the data will become available and for how long
The access period starts 3 months after the results are published
To whom data/document is available
Faculty members of Universities of Medical Sciences
Under which criteria data/document could be used
For further study and review of data details
From where data/document is obtainable
1. Sending an official email to the authors and project managers: Dr.Abdolrahim Asadollahi: a_asadollahi@sums.ac.ir Negar Paydar Jahromi: negar.paydar79.97@gmail.com 2. Refer to the Health Faculty of Shiraz University of Medical Sciences Address: Faculty of Health, Razi Blvd, Shiraz
What processes are involved for a request to access data/document
After sending an official e-mail to the project authors or project managers, the request will be reviewed by the relevant department and the Faculty of Health. After approval, data and documents will be sent to the applicant.
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