Evaluation the the effect of Orem’s self-care counselling on the post partum self- evaluation of primiparous women
Design
A randomized controlled clinical trial with a parallel group design of 58 participants
Settings and conduct
Research population comprise postpartum women of Mohammadshahr in the Alborz province. A sample of 58 eligible mothers will be selected by simple random. In intervention group, participants will attend weekly in group counselling session for 3 sessions (90 minutes) in groups of six people, according the Orem’s model. The participants will be evaluated before and 6 weeks after the intervention by postpartum self-evaluation questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being Iranian, being literated, primipara, low risk pregnancy, absence of physical and mental illness, absence of postpartum Depression, absence of postpartum complications, being interested to contribute in the study. Exclusion criteria: Neonatal illness, Neonatal Hospitalisation.
Intervention groups
"Intervention group" will receive group counselling in 3 sessions (90 minutes)weekly. "Control group" will not receive any counselling.
Main outcome variables
Postpartum self-evaluation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160424027557N8
Registration date:2018-10-13, 1397/07/21
Registration timing:registered_while_recruiting
Last update:2018-10-13, 1397/07/21
Update count:0
Registration date
2018-10-13, 1397/07/21
Registrant information
Name
Mahnaz Akbari Kamrani
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6007
Email address
dr.akbarikamrani@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of Orem’s self-care counselling on the postpartum self- evaluation of primiparous women
Public title
Effect of counselling on the postpartum self- evaluation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian
Being literated
Being married
Being primiparous
Having single pregnancy
Having low risk pregnancy
Having term newborn
Absence of physical and mental illness
Absence of postpartum Depression
Absence of postpartum complications
Being interested to contribute in the study
Exclusion criteria:
Neonatal illness
Neonatal Hospitalisation
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
The block sampling was used for random allocation using Excel software to form the groups. Samples were divided into intervention and control groups by quadruple random blocks. There were six possibilities for blocking (BAAB, ABAB, AABB, ABBA, BBAA, BABA). First, one of the blocks was selected and four of the participants in that block were selected. As a result, the number A belongs to the intervention group and the number B belongs to the control group.
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 Alborz University of Medical Sciences
Street address
Vice-Chancellor for Research and Technology, Alborz University of Medical Sciences, above Taleghani Square, Taleghani Square
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2018-02-24, 1396/12/05
Ethics committee reference number
IR.ABZUMS.REC.1396.203
Health conditions studied
1
Description of health condition studied
Routine postpartum follow-up
ICD-10 code
Z39.2
ICD-10 code description
Routine postpartum follow-up
Primary outcomes
1
Description
Postpartum self-evaluation
Timepoint
Before and after intervention
Method of measurement
Postpartum self-evaluation questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants will attend in group counselling (90 minutes) for 3 sessions in groups of six people weekly, according the Orem’s model. Counselling content includes: the purpose of the study, general health, developmental health and illness.
Category
Lifestyle
2
Description
Control group: Participants will not receive any intervention. After the study, a booklet containing the content of the consultation will be given to them.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Alborz University of Medical Sciences
Full name of responsible person
Maryam Chamangasht
Street address
Bakhtiari Ave., Tabatabaie Comprehensive Health Services Center
City
Mohammadshahr
Province
Alborz
Postal code
3198764653
Phone
+98 26 3631 2220
Email
khcalborz@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Noorisepehr
Street address
Vice-Chancellor for Research and Technology, Alborz University of Medical Sciences, above Taleghani Square, Taleghani Square
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3455 1034
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Maryam Chamangasht
Position
student
Latest degree
Master
Other areas of specialty/work
counseling in midwifery
Street address
Medicine Faculty., Nabovat Square., Booali Blvd
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3428 7463
Email
chamangasht2015@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Akbari Kamrani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Medicine Faculty., Nabovat Square., Booali Blvd
City
Karaj
Province
Alborz
Postal code
3149779543
Phone
+98 26 3428 7463
Email
Dr.akbarikamrani@abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Akbari Kamrani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Medicine Faculty., Nabovat Square., Booali Blvd
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3428 7463
Email
Dr.akbarikamrani@abzums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected variables
When the data will become available and for how long
From 2019
To whom data/document is available
It will be available only for people working in academic institutions.
Under which criteria data/document could be used
No Criterion
From where data/document is obtainable
By Email: Dr.akbarikamrani@abzums.ac.ir and Dr. Mahnaz Akbari Kamrani would be responsive
What processes are involved for a request to access data/document