Determining the effect of sleep hygiene education on the severity of insomnia and sleep quality of pregnant women referring to comprehensive health centers in Nahavand city in 2023
Design
Phase II clinical trial with control group and 1:1 ratio and with parallel groups will be conducted on 70 pregnant women with SHI score ≥ 16. Blocked random assignment will be done using web software (https://www.sealedenvelope.com/simple-randomiser/v1/lists) and with blocks of 4 and 6. Due to the nature of the study, blinding is not possible.
Settings and conduct
Pregnant women are placed in the intervention or control group based on the predetermined allocation sequence if they meet the study entry criteria. Sleep hygiene education sessions are held at Hamedan comprehensive health centers at intervals of one week. The duration of the sessions will be 45-60 minutes. Mothers in the control group received only routine care. To comply with ethical considerations, after the end of the study, a group meeting will be held for the mothers of the control group. In the 36th week of pregnancy, the mothers of both groups are invited to complete the questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women 18-35 years old, singleton pregnancy, gestational age 24-28 weeks at the time of entering the study, having literacy and SHI score ≥ 16 and ability to speak Persian.
ٍExclusion criteria: Sleep disorder before pregnancy, chronic medical problems, pregnancy complications, psychiatric disorders, night shift and cognitive problems
Intervention groups
In addition to routine care, people in the intervention group will participate in 4 sleep hygiene training sessions in groups of 5 people.Control group: routine care
Main outcome variables
Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201102049233N3
Registration date:2023-09-02, 1402/06/11
Registration timing:prospective
Last update:2023-09-02, 1402/06/11
Update count:0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
Farideh Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
f.kazemi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sleep hygiene education on the insomnia severity and sleep quality of pregnant women
Public title
Sleep hygiene education and the insomnia severity and sleep quality of pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be 18-35 years old.
The pregnancy is a singleton.
The gestational age at the time of entering the study should be 24-28 weeks.
Be literate in reading and writing.
Have obtained SHI (Sleep Hygiene Index) score ≥ 16.
Have the ability to speak Persian.
Exclusion criteria:
According to the person's own statements, have a sleep disorder before pregnancy
have chronic medical problems (such as diabetes, blood pressure, heart, kidney problems, etc.).
Have pregnancy complications (gestational diabetes, pregnancy blood pressure, bleeding, placental abruption, and placenta previa).
have psychiatric disorders according to the file in the SIB system
Have a night shift
Have cognitive problems
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In order to assign mothers to the intervention and control groups, a 4 and 6 random blocking method is used. To do this, the allocation sequence is first determined using AABB blocks before the start of the study. Then, the type of intervention is written in opaque closed envelopes based on the specified sequence and is numbered in sequence. Participants will complete a demographic and midwifery information questionnaire and receive an envelope before entering the study. People are then placed in one of the control or intervention groups based on the contents of the envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
In front of Mardom's Park, Research Square
City
Hamedan
Province
Hamadan
Postal code
6517838687
Approval date
2023-08-26, 1402/06/04
Ethics committee reference number
IR.UMSHA.REC.1402.422
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
O99.3
ICD-10 code description
Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Sleep quality scores
Timepoint
Before the intervention and 4 weeks after the end of the educational sessions
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes
1
Description
Sleep hygiene and insomnia severity
Timepoint
Before the intervention and 4 weeks after the end of the educatinal sessions
Method of measurement
Sleep Hygiene Index (SHI) and Insomnia Severity Index (ISI)
Intervention groups
1
Description
Intervention group: Pregnant women in the intervention group, in addition to routine care, will participate in 4 sessions of sleep hygiene education in groups of 5 people. The sessions are weekly and start from the gestational age of 24-28 weeks, and the meeting place will be held in comprehensive health centers of Nahavand city. The time of attendance is determined by prior coordination of pregnant women and by phone. The duration of the sessions will be 45-60 minutes. After the sessions, the training package is given to the participants to carry out the taught principles until the end of the pregnancy.
Category
Lifestyle
2
Description
Control group: Routine prenatal care
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers of Nahavand city
Full name of responsible person
Farideh Kazemi
Street address
Hamedan University of Medical Sciences (UMSHA), Pazhouhesh Crossroad., Hamadan, Iran.
City
hamadan
Province
Hamadan
Postal code
08138380150
Phone
+98 918 312 7351
Email
faridehkazemi21@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi, Deputy of research and technology of Hamadan University of Medical Sciences
Street address
Hamedan University of Medical Sciences (UMSHA), PaZhouhesh Crossroad., Hamadan, Iran.
City
Hamedan
Province
Hamadan
Postal code
08138380150
Phone
+98 918 312 7351
Email
shokoohi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Farideh Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Hamedan University of Medical Sciences (UMSHA), PaZhouhesh Crossroad., Hamadan, Iran.
City
Hamedan
Province
Hamadan
Postal code
08138380150
Phone
+98 81 3838 0150
Email
faridehkazemi21@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farideh Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Hamedan University of Medical Sciences (UMSHA), PaZhouhesh Crossroad., Hamadan, Iran.
City
Hamedan
Province
Hamadan
Postal code
08138380150
Phone
+98 81 3838 0150
Email
faridehkazemi21@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farideh Kazemi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Hamedan University of Medical Sciences (UMSHA), PaZhouhesh Crossroad., Hamadan, Iran.
City
Hamedan
Province
Hamadan
Postal code
6519964885
Phone
+98 81 3838 0150
Email
faridehkazemi21@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be accessible if necessary
When the data will become available and for how long
After the results are published
To whom data/document is available
The data will be provided to academic and scientific institutions if necessary
Under which criteria data/document could be used
If a meta-analysis is required, the data will be made available to the corresponding author
From where data/document is obtainable
Correspondence with the responsible person by email
What processes are involved for a request to access data/document
If you agree to the request, the data will be emailed.