The effect of counseling on relaxation on Sleep disturbances on third trimester of pregnancy in primigravida women attendent to health centers in Hamadan , 2015
Objective: This study is to determine the effect of counselling on relaxation on sleep disturbances on third trimester of pregnancy in primigravida women. This study is a semi experimental with two groups (experimental and control) with pre-test and post-test. This study comprised pregnant women attending to health care centers in Hamadan. Simple Random permutation block will be done. The sample size is 50 women in the intervention group and 50 women in control group. Inclusion criteria: First pregnancy; single fetus and gestational age 28-32 weeks; having sleep disturbance(Pittsburgh scale 5 or more) Exclusion criteria: Any problems in pregnancy during the study period. In the intervention group relaxation counseling will be trained by the researcher in two sessions. The intervention group each time, twice a day for 4 weeks for 20 minutes of relaxation will do. In this study primary outcome measure is sleep disturbances and secondary outcome measure is relaxation counseling.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509226888N12
Registration date:2015-10-02, 1394/07/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-02, 1394/07/10
Registrant information
Name
Fatemeh Shobeiri
Name of organization / entity
Hamadan Universiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
shobeiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of Research Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling on relaxation on Sleep disturbances on third trimester of pregnancy in primigravida women attendent to health centers in Hamadan , 2015
Public title
The effect of counseling on relaxation on Sleep disturbances on third trimester of pregnancy in primigravida women attendent to health centers in Hamadan , 2015
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of sleep disturbances; first pregnancy and wanted pregnancy; single fetus and gestational age 28-32weak; not having mental disorders, according to a psychiatrist; not having gestational diabetes, preeclampsia, bleeding, premature rupture of membrane...; having sleep disturbance(Pittsburgh scale 5 or more) exclusion criteria: Any problems in pregnancy during the study period (abruption, fetal abnormal situation, cord prolapse, bleeding, diabetes, hypertension, preterm labor and ...); Change Location; Failure to attend training classes
Age
No age limit
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
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
Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
65178
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
IR.UMSHA.REC.1394.208
Health conditions studied
1
Description of health condition studied
sleep
ICD-10 code
F51
ICD-10 code description
Nonorganic sleep disorders
Primary outcomes
1
Description
Sleep disturbance
Timepoint
weeks 28-32 and 32-36 of gestational age
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes
1
Description
relaxation
Timepoint
week 32-36 of gestational age
Method of measurement
Checklist
Intervention groups
1
Description
Relaxation training for 4 weeks twice a day for 20 minutes each time by the intervention group
Category
Other
2
Description
The control group will receive regular prenatal care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Healthcare center Samii 2
Full name of responsible person
Reyhaneh Ebrahimi
Street address
Taleghani street
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Research Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Bashirian Saeed
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Department of Research and Technology
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research Technology, Hamadan 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
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave, Hamadan
City
Hamadan
Postal code
6516845977
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
Hamadan University of Medical sciences, School of Nursing and Midwifery, Fahmideh Ave, Hamadan
City
Hamadan
Postal code
6516645977
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan Universiy of Medical Sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
Fahmideh Street, Hamadan Universiy of Medical Sciences
City
Hamedan
Postal code
6516645977
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)