Determining The effectiveness of an educational intervention based on self-help for sleep hygiene promotion on employees of Qazvin University of Medical Sciences
Design
Controlled, double-blind, randomized trials Randomized with parallel groups and Blind Evaluation of results, systematic randomization using an external site
Settings and conduct
This plan will be implemented on the staff of the Qazvin University of Medical Sciences.
The Insomnia Severity Index questionnaire will be used to screen for insomnia and low sleep health.
This questionnaire is provided online to the staff through communication channels such as telegrams to help people who are interested in participating in this research.
Individuals who scored more than 8 were randomly assigned to intervention and control groups and completed the Insomnia Index Index.
The intervention group will then receive an educational app designed to improve sleep hygiene.
Control group: Participants in the control group perform routine activities.
The intervention and control group will fill out the relevant questionnaire one and three and six months after the completion of the training to assess the impact of the intervention online.
Participants/Inclusion and exclusion criteria
Inclusion criteria: staff of the Qazvin University of Medical Sciences; having a laptop or smartphone; Internet access; being literate; getting a score of 8 to the top of the ISI questionnaire.
Non-compliance criteria: Non-participation in the study; With chronic disease; Severe psychological problems; Pregnancy ;current insomnia treatment ;having a child under two years of age
Intervention groups
Intervention group: Participants in the intervention group will receive an educational app designed to improve sleep hygiene.
Control group: Participants in the control group perform routine activities
Main outcome variables
sleep hygiene behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180131038582N1
Registration date:2018-09-01, 1397/06/10
Registration timing:retrospective
Last update:2018-09-01, 1397/06/10
Update count:0
Registration date
2018-09-01, 1397/06/10
Registrant information
Name
nilofar rajabimajd
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3562 2276
Email address
majd_nilofar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of an educational intervention based on self-help for sleep hygiene promotion on employees of Qazvin University of Medical Sciences
Public title
The effectiveness of an educational intervention based on self-help for sleep hygiene promotion
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
A staff member of the Qazvin University of Medical Sciences
having a laptop or computer or smartphone
Internet access
being literate (for reading and using the educational app
getting a score of 8 to the top on ISI questionnaire
Exclusion criteria:
Pregnancy
current insomnia treatment
having a child under two years of age
Non-participation in the study
Suffering from chronic illness
Severe psychological problems
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
308
Randomization (investigator's opinion)
Randomized
Randomization description
Using the Insomnia Severity Index (ISI) questionnaire to screen for insomnia and low sleep hygiene, people with a higher score of 8 will be selected and randomly selected using a randomized software. It is worth noting that the random unit Individuals will be individualized, and people will be placed in two groups of intervention and control.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are unaware of the allocation of study groups.The outcome evaluator did not know how to randomize the disease
And examine the data related to the outcome variables, regardless of the groups of individuals.
After collecting the data, the groups are named in alphabetical order so that the analyst from the intervention and control group is not informed.
Placebo
Not used
Assignment
Parallel
Other design features
This study is done online.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences., Shahid Bahonar Blvd., Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2018-02-19, 1396/11/30
Ethics committee reference number
IR.QUMS.REC.1396.455
Health conditions studied
1
Description of health condition studied
insomnia
ICD-10 code
G47.0
ICD-10 code description
Insomnia
Primary outcomes
1
Description
Sleep Quality
Timepoint
changes in PSQI baseline , 1 month, 3 months and 6 months follow-up
Method of measurement
The Pittsburgh Sleep Quality Index includes seven components of subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, the use of sleep medications and day time dysfunctions provide a total score of these seven components that allows us to better understand the quality and quantity of one's sleep. The Pittsburgh Sleep Quality Index is a self-reporting instrument consisting of nine questions designed to measure the quality of sleep disorders in a period of one month. The scale scores range from 0 to 21, with higher scores indicating poor quality of sleep and scores less than 5 considered as high quality of sleep
2
Description
sleep hygiene behavior
Timepoint
changes in sleep hygiene behavior baseline , 1 month, 3 months and 6 months follow-up
Method of measurement
Sleep hygiene behaviour will use three items to measure how many days the participants had good sleep hygiene behaviour
Secondary outcomes
1
Description
Anxiety and depression score
Timepoint
Before the intervention, one month ، three & Six months after the intervention, the questionnaire is completed.
Before the intervention, one month ، three & Six months after the intervention, the questionnaire is completed.
Method of measurement
psychological predictors of sleep hygiene behavior will be assessed using a using a self-reported measure. All items are rated on a Likert-type scale, ranging from 1 to 5.
Intervention groups
1
Description
Intervention group: They will receive an educational app designed to improve sleep, and will receive self-help training in a six-week training package.
Category
Behavior
2
Description
Control group: Participants in the control group perform routine activities
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences
Full name of responsible person
Amir Pakpour Haji Agha
Street address
Qazvin University of Medical Sciences., Shahid Bahonar Blvd., Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
pakpour_amir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Qazvin University of Medical Sciences., Shahid Bahonar Blvd., Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
sdh@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Nilofar Rajabimajd
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No.1426, Imam Khomeini Ave., Saidi Alley, Ziaabad Town
City
Qazvin
Province
Qazvin
Postal code
3485156955
Phone
+98 28 3562 2276
Fax
Email
majd_nilofar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Pakpour Haji Agha
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Qazvin University of Medical Sciences., Shahid Bahonar Blvd., Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
pakpour_amir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Nilofar Rajabimajd
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No.1426, Imam Khomeini Ave.,Saidi Alley .,Ziaabad Town
City
Qazvin
Province
Qazvin
Postal code
3485156955
Phone
+98 28 3562 2276
Fax
Email
majd_nilofar@yahoo.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
Not applicable
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