Investigating the effect of sleep hygiene methods on improving sleep quality in pregnant women with insomnia in the first trimester: a Randomized Clinical Trial
Investigating the effect of sleep hygiene methods on improving sleep quality in pregnant women with insomnia in the first trimester
Design
Clinical trial with intervention and control groups, with parallel groups, single blind, randomized using Randomiser software, on 108 patients.
Settings and conduct
Study place: The clinic of AlZahra Hospital will be in Tabriz; Study population: 108 pregnant women in the first trimester of pregnancy who scored 5 and higher in the Pittsburgh Sleep Quality Questionnaire; Type of blinding: one-way blind; How to blind:After completing the questionnaires, they will be provided to the analyzer in sealed envelopes, labeled Group A and Group B. In this way, the analyzer will be blinded in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age between 18 and 40 years; Pregnant women in the first trimester of pregnancy; Getting more than 5 Point Based On The Pittsburgh Sleep Quality Index.
Non inclusion criteria: Having chronic medical diseases; Smoking and alcohol consumption; Occurrence of severe stressors
Intervention groups
Intervention group: The group receiving sleep hygiene training, which is a 60-minute session
Control group: A group that will not receive any training.
Main outcome variables
Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190304042912N3
Registration date:2022-04-11, 1401/01/22
Registration timing:registered_while_recruiting
Last update:2022-04-11, 1401/01/22
Update count:0
Registration date
2022-04-11, 1401/01/22
Registrant information
Name
sanaz moosavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3553 9161
Email address
musevis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2023-04-09, 1402/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of sleep hygiene methods on improving sleep quality in pregnant women with insomnia in the first trimester: a Randomized Clinical Trial
Public title
The effect of sleep hygiene methods on improving sleep quality in pregnant women with insomnia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 40 years
Pregnant women in the first trimester of pregnancy
Getting more than 5 Point Based On The Pittsburgh Sleep Quality Index
Literacy to complete questionnaires
Willingness to participate in the study
Exclusion criteria:
Having chronic medical diseases
Smoking and alcohol consumption
Occurrence of severe stressors such as death of first-degree relatives during the last month before the study
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be divided into two groups of intervention and control, using random blocking method with the blocks of size of four and six with 1: 1 allocation sequence.
The allocation sequence will be determined by the researcher in the study using Randomiser software.
Blinding (investigator's opinion)
Single blinded
Blinding description
After completing the questionnaires, they will be provided to the analyzer in sealed envelopes, labeled Group A and Group B. In this way, the analyzer will be blinded in this study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Third Floor, Number 2 Central Building, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2022-03-09, 1400/12/18
Ethics committee reference number
IR.TBZMED.REC.1401.004
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
Before the intervention, every week after the intervention for three weeks
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After coordination with the participants, sleep hygiene training will be held in the form of a 60-minute face-to-face session, in which sleep hygiene items will be fully taught and also provided to individuals in printed form.
Category
Rehabilitation
2
Description
Control group: The control group will not receive any training.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Sanaz Moosavi
Street address
Alzahra Hospital, South Artesh St.,Tabriz, iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
moosavisanaz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
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,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Sanaz Moosavi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 1553 9161
Email
moosavisanaz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sanaz Moosavi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 1553 9161
Email
moosavisanaz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sanaz Moosavi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 1553 9161
Email
moosavisanaz@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
Undecided - It is not yet known if there will be a plan to make this available
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