Among high risk pregnant women 180 cases that their scores from Peterborough Sleep Quality Index questionnaire are 5 or more will be selected. The subjects are randomly divided into 2 groups (intervention and control group). Relaxation techniques will be taught to intervention group.
The intervention group will carry out the relaxation techniques for 8 sessions while the control group will be received routine care only. In the end of intervention, both the intervention and the control group will fill Peterborough Sleep Quality Index questionnaire again. Furthermore such variables like newborn weight and apgar score, PH and Interleukin concentration of umbilical blood samples will be measured after delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013092310327N5
Registration date:2014-09-13, 1393/06/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-13, 1393/06/22
Registrant information
Name
Farideh Vaziri
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 9131
Email address
vazirif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2013-12-21, 1392/09/30
Expected recruitment end date
2014-08-21, 1393/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of relaxation techniques on fetal outcomes in high risk pregnant women with sleep breathing disorders
Public title
the effecst of relaxation techniques on fetal outcomes in high risk pregnant women with sleep breathing disorders
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: people tend to have the cooperation;19 to 35 year old pregnant women ; pregnant women with sleep breathing disorder diagnosed by Pitsburg questionnaire; third trimester pregnant women admitted with the diagnosis of gestational diabetes requires insulin; type II diabetes and preeclapsia; having pregnancy more than 28 weeks; not to be drug and substance abuser; singleton l pregnancy
- exclusion criteria: having chronic disease; fetal abnormalities in ultrasound; abnormal vaginal bleeding
Age
From 19 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Shiraz University of Medical Sciences
Street address
Central building Shiraz University of Medical Sciences, Zand Ave, Shiraz
City
Shiraz
Postal code
713451978
Approval date
2013-12-21, 1392/09/30
Ethics committee reference number
92-6814
Health conditions studied
1
Description of health condition studied
Fetal outcomes in high risk pregnant women with sleep disordered breathing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Interleukin 6
Timepoint
After Delivery
Method of measurement
Laboratory Kit
2
Description
Apgar score
Timepoint
Birth Time
Method of measurement
Apgar Score category
3
Description
newborn Weight
Timepoint
Birth Time
Method of measurement
Weight scales
4
Description
PH
Timepoint
After Delivery
Method of measurement
Laboratory Kit
Secondary outcomes
1
Description
Sleep Breathing Disorder
Timepoint
Before And After Intervention
Method of measurement
Pitsburg Sleep Disorder Index Questionnaire
Intervention groups
1
Description
In intervention group: Muscle relaxation techniques for 8 sessions
Category
Treatment - Other
2
Description
In the control group: routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Mona Dorakvandi
Street address
The beginning of Chamran Blv, Shiraz, Fars
City
Shiraz
2
Recruitment center
Name of recruitment center
Hazrat Zeinab Hospital
Full name of responsible person
Mona Dorakvandi
Street address
Defa Moqadas Square, Shiraz, Fars
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Gholam Reza Hatam
Street address
7th Floor, Shiraz University of Medical Sciences, Central building , Zand Ave, Shiraz
City
Shiraz
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 of Shiraz University of Medical Sciences
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
Faculty of Nursing and Midwifery
Full name of responsible person
Farideh Vaziri
Position
Master Of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Namazi Square, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 1647 4252
Fax
Email
vazirif@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty OF Nursing And Midwifery
Full name of responsible person
Farideh Vaziri
Position
Master OF Midwifery
Other areas of specialty/work
Street address
Faculty Of Nursing And Midwifery, Namazi Square, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 1647 4252
Fax
Email
vazirif@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty Of Nursing And Midwifery
Full name of responsible person
Mona Dorakvandi
Position
Master OF Midwifery
Other areas of specialty/work
Street address
Faculty Of Nursing And Midwifery, Namazi Square, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 1647 4252
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)