It is a Randomized Controlled Trial study. Research population will be 100 pregnant women 20-40 years old with the pregnancy age of 16-20 weeks that visit a two chosen health care center of Mako Township from Euromie University of Medical Science and have inclusion criteria. We will use convenience sampling to recruit people to the study. After completing the informed consent form the demographic questionnaire and Pittsburg sleep quality index will be completed by the participants. The pregnant women with sleep score over five will complete Quality of life questionnaire (WHOQOL: BREF) after that they will randomly divide into case and control groups. Cases will divide into five groups based on the gestational age. They will receive Health behavior education in four one- hour meeting from the 22th to 25th week of pregnancy. Control group will receive routine prenatal care. Follow-ups will assess by completing Quality of life questionnaire (WHOQOL: BREF) in both groups in 29, 33 and 37 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204149463N1
Registration date:2012-06-15, 1391/03/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-15, 1391/03/26
Registrant information
Name
Zahra Behboodi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
behboodi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science, vice chancellor for research(primary sponsor)
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-07-19, 1391/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of behavioral health sleep education on the quality of life in the pregnant women with sleep disorder
Public title
The impact of behavioral health sleep education on the quality of life in the pregnant women with sleep disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Iranian- pregnant women; Women with gestational age 16-20 weeks; Without known physical , mental and psychological illnesses; Ages 20 to 40 years; Able for reading and writing; Dont use of smoking, drugs, drinking, sleep and hormons drugs; Don’t exist abortion in previous pregnancy.
Exclusion criteria: During the study, mothers who are involved in adverse events such as death of loved ones; Mothers who don’t desire to continue; Appearance of psychological and physical illness during study; Change of sleep condition with trip; chang of diet and habitat; use of drugs in during study.
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:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and Midwifery,Tehran Univercity of Medical Science
Street address
Near Ghods Street on keshavarz Boulevard
City
Tehran
Postal code
Approval date
2012-05-19, 1391/02/30
Ethics committee reference number
54839
Health conditions studied
1
Description of health condition studied
Quality of life
ICD-10 code
z34.8
ICD-10 code description
Supervision of other normal pregnancy
Primary outcomes
1
Description
sleep quality
Timepoint
16-20 weeks of pregnancy
Method of measurement
Pittsburgh Sleep Quality Index questionare
2
Description
Quality of life
Timepoint
16-20 weeks of pregnancy
Method of measurement
Quality of life questionnaire of WHO(WHOQOL: BREF)
Secondary outcomes
1
Description
Physical health OF Quality of life
Timepoint
29, 33 and 39 weeks of pregnancy
Method of measurement
Quality of life questionnaire OF WHO(WHOQOL: BREF)
2
Description
Psychological Health OF Quality of life
Timepoint
29, 33 and 39 weeks of pregnancy
Method of measurement
Quality of life questionnaire of WHO(WHOQOL: BREF)
3
Description
Social Relationships OF Quality of life
Timepoint
29, 33 and 39 weeks of pregnancy
Method of measurement
Quality of life questionnaire of WHO (WHOQOL: BREF)
4
Description
Environmental Quality of life
Timepoint
29, 33 and 39 weeks of pregnancy
Method of measurement
Quality of life questionnaire OF WHO(WHOQOL: BREF)
Intervention groups
1
Description
Intervention group: health behavior education will educate on one hour duration in four meeting, start 22week , end25week and different content in each meeting
Category
Other
2
Description
Control group: Routine normal care on prenatal care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Maku Township, Euromiea University of Medical Science
Full name of responsible person
Elham Rezai
Street address
Maku
City
Euromiea
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science, vice chancellor for research(primary sponsor
Full name of responsible person
Dr. Akbar Fotuhi
Street address
khods street, keshavarz boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science, vice chancellor for research(primary sponsor
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
Tehran University of Medical Science
Full name of responsible person
Elham Rezaei
Position
master of science student of midwifery
Other areas of specialty/work
Street address
Tohid squar, School of Midwifery and Nursing
City
Tehran
Postal code
Phone
+98 989144633116
Fax
Email
rezai520@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Zahra Behboodi Moghadam
Position
PHD of Reproductive Health
Other areas of specialty/work
Street address
Tohid squar, School of Midwifery and Nursing
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
bahar_behboodi@yahoo.com
Web page address
bahar_behboodi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Elham Rezaei
Position
Master of Science Student
Other areas of specialty/work
Street address
Tohid squar, school of midwifery and nursing
City
Tehran
Postal code
Phone
+98 989144633116
Fax
Email
rezai520@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)