The effect of educational package on functional status and maternal self-confidence of primiparous women in postpartum period: a randomized controlled clinical trial
The present randomized controlled clinical trial aims to evaluate the impact of training packages on functional status and maternal self- confidence in the postpartum period. The samples will be nulliparous pregnant women aged 18-35 years, singleton pregnancy and term birth. The women whose newborns are hospitalized or have congenital malformations or dead will be excluded. The study population will include nulliparous women at 10-15 days postpartum. The main sample size is determined to be 68 in each study groups. Then participants in control group will receive only routine postpartum care while the intervention group will be received necessary training. The first session will take place within 10-15 days after delivery. Thus, they will be scheduled to 30 minutes face-to-face training sessions. Moreover, educational booklets will be distributed among the participants at the end of the first session. Second, third and fourth sessions, lasting 20 minutes, will be conducted using telephone (respectively) two, three and four weeks after the first intervention session. Last 10 minutes of it will be dedicated to answering the participants' questions. There will be 3-week interval after initial intervention completion in order to illustrate the impact of education on improving functional status and self-confidence of the new mothers (primary outcome). Then, at the eighth week postpartum both groups (the women in intervention and control groups) will be invited to attend in the health center and complete a functional status and maternal self-confidence questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509283027N27
Registration date:2015-11-02, 1394/08/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-02, 1394/08/11
Registrant information
Name
Fahimeh Sehhatie Shafaie
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
sehhatief@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice chancellor Tabriz University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational package on functional status and maternal self-confidence of primiparous women in postpartum period: a randomized controlled clinical trial
Public title
The effect of educational package on functional status and maternal self-confidence of primiparous women in postpartum period: a randomized controlled clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
(Inclusion Criteria: Primiparous women; 18-35 years old; Having singleton pregnancy; Term birth (Between 37-42 weeks); Having desire to participate in this study; Having literacy tips and more; Having physical health according to the mother; Exclusion Criteria: In case of cancellation of continuing to work while completing the questionnaire; The accident occurred during the 3 months prior to the study ( death or serious illness of close relatives ); A history of mental illness and depression in women before pregnancy and during pregnancy according to the participant; Newborns are hospitalized due to illness in postpartum period; Have congenital malformations in the infant; Infant 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:
136
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
Research vice chancellor Tabriz University of Medical Sciences
Street address
Tabriz/Golgasht street/ Tabriz University of Medical Sciences/Research vice chancellor
City
Tabriz
Postal code
info@researchvice.tb
Approval date
2015-09-14, 1394/06/23
Ethics committee reference number
TBZMED.REC.1394.547
Health conditions studied
1
Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
O94
ICD-10 code description
Sequelae of complication of pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Functional status
Timepoint
15-10 days after childbirth and 8 week after childbirth
Method of measurement
The Inventory of Functional Status After Childbirth (IFSAC)
2
Description
Maternal self-confidence
Timepoint
15-10 days after childbirth and 8 week after childbirth
Method of measurement
(LMSCS= Lips Maternal Self-Confidence Score)
Secondary outcomes
1
Description
The relationship between the functional status and maternal self-confidence
Timepoint
15-10 days after childbirth
Method of measurement
The Inventory of Functional Status After Childbirth (IFSAC) and LMSCS= Lips Maternal Self-Confidence Score
2
Description
The relationship between personal- social characteristics and functional status
Timepoint
15-10 days after birth
Method of measurement
The Inventory of Functional Status After Childbirth (IFSAC) and personal- social questionnaire
3
Description
The relationship between personal- social characteristics and maternal self-confidence
Timepoint
10-15 days after birth
Method of measurement
LMSCS= Lips Maternal Self-Confidence Score and personal- social questionnaire
Intervention groups
1
Description
Intervention group: Educational package for the first session will take place within 10-15 days after delivery. Thus, they will be scheduled to 30 minutes face-to-face training sessions. Moreover, educational booklets will be distributed among the participants at the end of the first session. Second, third and fourth sessions, lasting 20 minutes, will be conducted using telephone (respectively) two, three and four weeks after the first intervention session. Last 10 minutes of it will be dedicated to answering the participants' questions
Category
Lifestyle
2
Description
Control group: Routine care after delivery on days 10-15 and 42-60
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Tabriz
Full name of responsible person
Fahimeh Sehhatie Shafaie
Street address
Tabriz, Sharieati street, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research vice chancellor Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Street address
Tabriz, Sharieati street, Faculty of Nursing and Midwifery
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice chancellor Tabriz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery of Tabriz
Full name of responsible person
Fahimeh Sehhatie Shafaie
Position
Assistant Professor
Other areas of specialty/work
Street address
Tabriz, Sharieati street, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
00
Fax
Email
sehhatief@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery of Tabriz
Full name of responsible person
Fahimeh Sehhatie Shafaie
Position
Assistant Professor
Other areas of specialty/work
Street address
Tabriz, Sharieati street, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
00
Fax
Email
sehhatief@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)