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Comparing the effect of bright light and not having bright light on circadian rhythm changes of temperature and melatonin and fatigue in shift worker nurses

Protocol summary

Summary
In this study we assessed the effect of bright light emitted by light box on circadian rhythm of body temperature, melatonin, fatigue, and sleepiness in nurses. The subjects are selected randomly by random-number table, from shift worker nurses who are in fixed shift work, in Farabi Hospital. 44 healthy female nurses aging 20-40 will be chosen. The nurses will be divided into two groups of intervention and control. In the first stage, bright light will be emitted to the nurses in the intervention group by the light box, and bright light will not be emitted to the control group. 10,000 lux brightness range of light for thirty minutes after 4 hours from the beginning of the shift will be used. In the next stage (one month later), we will emit bright light to the control group of first stage and vice versa (cross over). As the intervention is the emitting of the light, the blindness is not possible. Main outcome measure, we will assess after intervention is changing procedure of circadian rhythm in two groups. Primary outcome measures are salivatory melatonin and body temperature and secondary outcome measures are fatigue and sleepiness. Salivatory melatonin will be measured at 4:00 am and 4:00 pm next day. Body temperature, fatigue (Visual Analogue Scale) and, sleepiness (Karolinska Scale), will be measured every hour, during next 24 hours.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016121331395N1
Registration date: 2017-09-15, 1396/06/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-15, 1396/06/24
Registrant information
Name
Maryam Maghsoudipour
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0119
Email address
ma.maghsoudipoor@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of social welfare and rehabilitation sciences
Expected recruitment start date
2017-02-28, 1395/12/10
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of bright light and not having bright light on circadian rhythm changes of temperature and melatonin and fatigue in shift worker nurses
Public title
The effect of bright light on circadian rhythm changes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Nurses who have fixed night shift work; Female nurses who are willing to cooperate; The age of participants should be in the range of 20 - 40 years; The work experience of participants should be between 1 - 10 years Exclusion criteria: Non- cooperation; Nurses who can not participate a session; Nurses who have the history of psychiatric diseases; Nurses who use hypnotic drugs; Nurses who have sleep disorders such as obstructive sleep apnoea
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
The method of randomization; by random-number table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
Evin, Daneshjoo Blvd., Koodakyar St. University of Social Welfare and Rehabilitation Sciences
City
Tehran
Postal code
1985713834
Approval date
2014-12-22, 1393/10/01
Ethics committee reference number
USWR.REC.1393.205

Health conditions studied

1

Description of health condition studied
Shift work circadian rhythm disorder
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
body temperature
Timepoint
every hour during next 24 hours
Method of measurement
by Thermometer (Degrees Celsius)

2

Description
Salivary melatonin
Timepoint
at 4:00 am and 4:00 pm coming day after intervention
Method of measurement
Salivary melatonin kit (picogram/milliliter)

Secondary outcomes

1

Description
sleepiness
Timepoint
every hour during next 24 hours after intervention
Method of measurement
Karolinska Sleepiness Scale

2

Description
fatigue
Timepoint
every hour during next 24 hours after intervention
Method of measurement
Visual Analog Scale (VAS)

Intervention groups

1

Description
In case group bright light is emitted to shift work nurses
Category
Other

2

Description
In control group the light is not emitted.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Street address
Qazvin Square
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr Hamidreza Khanke
Street address
Koodakyar St., Daneshjoo Blvd., Evin, University of Social Welfare and Rehabilitation Sciences ,Vice chancellor for research
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of University of Social Welfare and Rehabilitation 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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Maryam Maghsoudipour
Position
Faculty Member
Other areas of specialty/work
Street address
Evin, Daneshjoo Blvd., Koodakyar St., University of Social Welfare and Rehabilitation Sciences, Ergonomics Department
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0119
Fax
Email
maryammaghsoudi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Maryam Maghsoudipour
Position
Occupational Medicine Specialist and Sleep Medicine Fellow
Other areas of specialty/work
Street address
Evin, Daneshjoo Blvd., Koodakyar St., University of Social Welfare and Rehabilitation Sciences, Ergonomics Department
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0119
Fax
Email
maryammaghsoudi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Maryam Maghsoudipour
Position
Faculty member
Other areas of specialty/work
Street address
Evin, Daneshjoo Blvd., Koodakyar St., University of Social Welfare and Rehabilitation Sciences, Ergonomics Department
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0119
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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