The aim of this research is to determine the effect of educational intervention on sleep quality of pregnant women referring to health centers of Meshginshahr. This study is a randomized clinical trial. The research population are pregnant women referring to health centers of Meshginshahr and meet inclusion criteria. The main inclusion criterion is to have a low – risk pregnancy and the pregnancy age between 26-32 weeks.
The main exclusion criterion is the appearance of pregnancy complications during the study. Sample size is 150 persons.
After receiving a written letter of satisfaction from samples, first the questionnaire of demographic characteristics and Pittsburg sleep quality questionnaire will be completed by research samples. Then, they will be randomly included in two groups of intervention and control. Randomization is done with Randlist software.
Control group will receive only routine prenatal care, and intervention group will also receive the package of sleep health education in addition to this care, and the researcher will teach them the content of educational package that consists of general and specific points of sleep health during pregnancy within two 2- hours’ sessions with one week interval. The researcher will give her phone number to intervention group for calling her in the cases of presence of problem about educational package.
After one month, Pittsburg sleep questionnaire will be completed by both groups again, and pre – intervention and post – intervention sleep quality will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201148459N3
Registration date:2013-01-26, 1391/11/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-26, 1391/11/07
Registrant information
Name
Shirin Hasanpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
hasanpoorsh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-05-23, 1392/03/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The randomised clinical trial of determination the effect of educational intervention on sleep quality of pregnant women
Public title
The effect of education on sleep quality of pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1- The age between 18-35 years.
2- Gestational age between 26-32 weeks.
3- Singleton pregnancy 4- Not having night shift.
5- Having at least guidance education.
6- Not having children under two years old
Exclusion criteria: 1-Fetal death 2- Preterm labor
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:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Samples of research will be allocated in two groups by Randlist software and with blocks of size 4 and 6. To hide the allocation, mothers will be given a number based on their presence priority at hospital. Then by using A and B codes that will be placed in sealed envelopes with sequence numbers, the type of interventions will be determined. So mothers will be placed in one of the two groups randomly.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Central Organization of Tabriz University Of Medical Sciences, Golgasht street,Tabriz
City
Tabriz
Postal code
Approval date
2012-12-03, 1391/09/13
Ethics committee reference number
91152
Health conditions studied
1
Description of health condition studied
Quality of sleep
ICD-10 code
026.9
ICD-10 code description
Pregnancy- related condition, unspecified
Primary outcomes
1
Description
Sleep quality
Timepoint
Before education and one month after education
Method of measurement
Pittsburgh sleep quality questionnaire
Secondary outcomes
1
Description
Pregnancy outcome
Timepoint
After delivery
Method of measurement
Based on medical records
Intervention groups
1
Description
Intervention group: Intervention group will receive the package of sleep health education in addition to routine prenatal care, and the researcher will teach them the content of educational package that consists of general and specific points of sleep health during pregnancy within two 2- hours’ sessions with the interval of one week.
After one month, sleep quality will be measured by Pittsburg sleep questionnaire.
Category
Treatment - Other
2
Description
Control group: The control group will receive routine prenatal care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Meshginshahr Health Center
Full name of responsible person
Mansoureh Eshgi
Street address
22 Bahman Street, Imam Square, Meshginshahr City
City
Meshginshahr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr Sakineh Mohamad Alizadeh
Street address
Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences, Vice chancellor for research
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
Tabriz University of Medical Sciences, School of Nursing and Midwifery, Tabriz
Full name of responsible person
Mansoureh Eshgi
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, South Shariati Street
City
Tabriz
Postal code
51745347
Phone
+98 41 1479 6770
Fax
Email
shirinhasanpoor@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences, School of Nursing and Midwifery, Tabriz
Full name of responsible person
Shirin Hasanpoor
Position
Master of sciences in midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 1479 6969
Fax
Email
shirinhasanpoor@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences, School of Nursing and Midwifery, Tabriz
Full name of responsible person
Mansoureh Eshgi
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 1479 6969
Fax
Email
shirinhasanpoor@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)