Determining the effect of bright light intervention on sleepiness and oral temperature of hospital night workers
Design
Participants were randomly assigned to intervention groups 1 and 2. The intervention group 1 received a brilliant light for the first time for 2 nights. At the same time, the intervention group 2 was exposed to normal light and after 6 days (washing period), the intervention in each group was changed to the intervention used in the other group. The exposure level is three times a night (For 1 hour each time) and each of the people in the intervention group exposed to 2500 LUX (in the presence of the room in break time). The sample size was 70 in each group. The study was a phase three clinical trial.
Settings and conduct
The intervention was cross-over and double blinded. That the researchers and the participants were not aware of the type of light received.
The intervention was among shift workers at the Asia Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Participants will be fully satisfied with the participation in the research; Participants will be shift workers of the Asia Hospital in Tehran; participants must have been engaged in shift working for at least one year.
Non Inclusion criteria: drugs or opioid use
Intervention groups
Intervention group 1: The participants received 2500 LUX light. Then they exposed to normal light 300LUX after 6-day wash out period.
Intervention group 2: the participants received 300LUX normal light. Then they exposed to2500 LUX light after 6-day wash out period.
Main outcome variables
The sleepiness rate; oral temperature rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180412039280N1
Registration date:2019-01-04, 1397/10/14
Registration timing:retrospective
Last update:2019-01-04, 1397/10/14
Update count:0
Registration date
2019-01-04, 1397/10/14
Registrant information
Name
mohsen poursadeghiyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0084
Email address
mo.poursadeghiyan@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2017-07-23, 1396/05/01
Trial completion date
2017-07-23, 1396/05/01
Scientific title
Evaluation of the effects of bright light exposure on sleepiness and oral temperature among hospital night shift staffs
Public title
The effects of bright light exposure on sleepiness and oral temperature
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study.
Shift Workers at the Asia Hospital in Tehran
working more than one year at night shifts .
Exclusion criteria:
substances or drugs user
Age
To 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
147
Actual sample size reached:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using Random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
The current study was double-blind. The researchers and participants were unaware of the type of light received.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IR.USWR.Rec.1396.77
Health conditions studied
1
Description of health condition studied
sleepiness
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Drowsiness
Timepoint
before exposure and after exposure
Method of measurement
Stanford sleepiness scale questionnaire
2
Description
Oral temperature
Timepoint
before exposure and after exposure
Method of measurement
Medical mercury thermomete
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The participants received 2500 LUX light. Then they exposed to normal light 300LUX after 6-day wash out period.
Category
Treatment - Devices
2
Description
Intervention group 2: the participants received 300LUX normal light. Then they exposed to2500 LUX light after 6-day wash out period.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Asia Hospital
Full name of responsible person
Mohsen Poursadeghiyan
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
poursadeghiyan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Ahmad Ali Akbari Kamrani
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0043
Email
akbarikamrani@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
contact.organization_id
0
Name of organization / entity
Full name of responsible person
Mohsen Poursadeghiyan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Internal Medicine
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0043
Email
poursadeghiyan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohsen Poursadeghiyan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Health
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21222180043
Email
poursadeghiyan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohsen Poursadeghiyan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Health
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0043
Email
poursadeghiyan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD