Objectives: To assess the effect of illumination on salivary melatonin and mental health in elderly people
Design: A before-after clinical trial
Setting and conduct: The elderly people who live in Yase Sefid and Tolooa nursing homes in Hamadan city.
Participants including major eligibility criteria: The nurses with the following criteria will be included in the study: age of 65 or older; not having acute physical or psychological disease; no addiction to cigarette, narcotic or alcohol.
Intervention: The participants will be asked to walk or sit under sun light from 6 to 10 am and from 4 to 5 pm for 4 weeks.
Main outcome measures: Salivary melatonin and mental health using GHQ, VAS, and KSS questionnaires will be assessed at baseline, two and four weeks later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203299014N10
Registration date:2012-07-23, 1391/05/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-07-23, 1391/05/02
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of illumination on salivary melatonin and mental health in elderly people: a before-after clinical trial
Public title
Effect of illumination on salivary melatonin and mental health in elderly people
Purpose
Prevention
Inclusion/Exclusion criteria
The elderly people who live in nursing home with the following criteria will be included in the study: (a) age of 65 or older; (b) not having acute physical or psychological disease; (c) no addiction to cigarette, narcotic or alcohol.
Age
From 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
A before-after trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Local Human Subject Review board
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Approval date
2012-07-01, 1391/04/11
Ethics committee reference number
D/P/16/35/9/1160
Health conditions studied
1
Description of health condition studied
Mental health
ICD-10 code
Z00
ICD-10 code description
General examination and investigation of persons without complaint and reported diagnosis
Primary outcomes
1
Description
Salivary melatonin
Timepoint
Baseline, two and four weeks later
Method of measurement
Laboratory
Secondary outcomes
1
Description
Mental health
Timepoint
Baseline, two and four weeks later.
Method of measurement
GHQ, VAS, and KSS questionnaires
Intervention groups
1
Description
Intervention group: The participants will walk or sit under sun light from 9 to 10 am and from 4 to 5 pm for 4 weeks.
Category
Other
2
Description
Control group: The same group before intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yase Sefid and Tolooa nursing homes in Hamadan city
Full name of responsible person
Dr Rstam Golmohammadi
Street address
Research Center for Health Sciences, Department of Occupational Health, School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vic-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Heidar Tavilani
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Research Center for Health Sciences, Department of Epidemiology & Biostatistics
Full name of responsible person
Dr Jalal Poorolajal
Position
MD, PhD, Assistant Professor of Epidemiology
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0509
Fax
+98 81 1838 0509
Email
poorolajal@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Center for Health Sciences, Department of Occupational Health
Full name of responsible person
Dr Rostam Golmohammadi
Position
PhD
Other areas of specialty/work
Street address
Research Center for Health Sciences, Department of Occupational Health, School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0090
Fax
+98 81 1838 0509
Email
golmohamadi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)