This study aims to investigate the effectiveness of posture reform self-care education on physical and mental health of pregnant women. Design: A randomized multicenter non-blinded controlled trial. Setting and conduct: The overall aim and setting of the study are explained for eligible people. Samples will be allocated to intervention and control groups through block randomization with block size of 4 and informed consents are completed. The control group will receive routine care. The intervention group will participate in training sessions (3 sessions) as well as receiving routine care. Sessions are held weekly. Training by multimedia such PowerPoint, role playing, group discussions, pamphlets and educational CDs will be performed. Content includes: anatomic and physiologic changes during pregnancy, the most common pregnancy complaints and posture reform in pregnancy. Then they are followed by phone until the end of the pregnancy. Inclusion criteria: gestational age between 20 and 24 weeks; low back pain; chest pain and lumbar pain, non-pathological; maximum number of pregnancy is 2; maternal age between 18 and 35 years; singleton pregnancy; healthy and normal fetus; negative history of disease; no history of uterine bleeding; no history of orthopedic disease and low back pain; pathological chest pain and lumbar pain before and during pregnancy; no history of accidents that have been caused musculoskeletal problems; no history of congenital musculoskeletal problems; having at least primary education.
Exclusion criteria:refuse the training program; development of the disease (hypertension, diabetes, etc.) and complications of pregnancy (oligo /polyhydramnios, fetal abnormalities, intrauterine fetal death, etc.); abnormal bleeding such as placenta previa,; losing their own or husband's jobs during pregnancy; relatives' death
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070425480N2
Registration date:2016-08-03, 1395/05/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-03, 1395/05/13
Registrant information
Name
Masoumeh Sharifzadeh
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4466 6828
Email address
sharifzade@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research; Shahroud University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-04-19, 1396/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of posture reform self-care education on physical and mental health of pregnant women
Public title
The effectiveness of posture reform self-care education on physical and mental health of pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: gestational age between 20 and 24 weeks; low back pain; chest pain and lumbar pain, non-pathological; maximum number of pregnancy is 2; maternal age between 18 and 35 years; singleton pregnancy; healthy and normal fetus; negative history of disease; no history of uterine bleeding; no history of orthopedic disease and low back pain; pathological chest pain and lumbar pain before and during pregnancy; no history of accidents that have been caused musculoskeletal problems; no history of congenital musculoskeletal problems; having at least primary education.
Exclusion criteria:refuse the training program; development of the disease (hypertension, diabetes, etc.) and complications of pregnancy (oligo /polyhydramnios, fetal abnormalities, intrauterine fetal death, etc.); abnormal bleeding such as placenta previa,; losing their own or husband's jobs during pregnancy; relatives' death
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:
116
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 Shahroud University of Medical Sciences
Street address
Central building of Shahroud University of Medical Sciences, Tir Square, Shahroud
City
Shahroud
Postal code
3614773955
Approval date
2016-06-25, 1395/04/05
Ethics committee reference number
IR. SHMU.REC.1395.30
Health conditions studied
1
Description of health condition studied
Mental health of pregnant
ICD-10 code
O99
ICD-10 code description
Other mental disorders complicating the puerperium
2
Description of health condition studied
Physical health of pregnant
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
physical health
Timepoint
Gestational age between 20 and 24 weeks and then 36 weeks
Method of measurement
Roland-Morris Disability Questionnaire- Iranian Version, Body Map, Ware and Sherbourne -MOS 36-Item Short-Form Health Survey (SF-36)
2
Description
mental health
Timepoint
Gestational age between 20 and 24 weeks and then 36 weeks
Method of measurement
well being, Ware and Sherbourne -MOS 36-Item Short-Form Health Survey (SF-36)questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
The control group will receive routine care.
Category
Lifestyle
2
Description
The intervention group will participate in training sessions (3sessions) as well as receiving routine care. Sessions are held weekly. training by multimedia such PowerPoint, role playing, group discussions, pamphlets and educational CDs is perform. Content includes: anatomic and physiologic changes during pregnancy, the most common pregnancy complaints and reform posture in pregnancy. Then they are followed by phone call.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Urban Health Center of Sabzevar University of Medical Sciences
Full name of responsible person
Masoumeh Sharifzadeh
Street address
Central building of Shahroud University of Medical Sciences, Tir Square,Shahroud. Semnan Iran, Islamic Republic Of
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahroud University of Medical Sciences
Full name of responsible person
Dr Mohammadhasan Emamian
Street address
Central building of Shahroud University of Medical Sciences, Tir Square,Shahroud. Semnan Iran, Islamic Republic Of
City
Shahroud
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 Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Masoumeh Sharifzadeh
Position
Master science of student counseling midwiferys
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences,Hafte Tir Square, Shahroud
City
Shahroud
Postal code
Phone
00
Fax
Email
msharifzade@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Nahid bolbol haghighi
Position
Faculty member
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences, Hafte Tir Square
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 4499
Fax
Email
Nbhaghighi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud university of medical sciences
Full name of responsible person
Masoumeh Sharifzadeh
Position
Master science of student counseling midwifery
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences,Hafte Tir Square, Shahroud. Shahroud Semnan Iran, Islamic Republic Of
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 4499
Fax
Email
msharifzade@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)