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Effect of Midwifery Counseling on postpartum Quality of Life of Primiparous Women With Body image Concerns

Protocol summary

Study aim
Determining The Effect of Consultation on Postpartum Quality of Life in Primiparous Women with Body image Concern
Design
Clinical trial is a randomized, with Control group and paralle groups, not blinded,
Settings and conduct
After obtaining informed consent of participants samples based on quarterly block randomization will be divided into two intervention and control groups. In This study blinding is impossible
Participants/Inclusion and exclusion criteria
Having a score lower than 138 from a body image questionnaire, be Iranian, First pregnancy. Exit criteria: Non-participation in 1 Full Sessions of Weekly Counseling,
Intervention groups
Intervention group: Primiparous Women with Body image concerns with entry criteria; who will receive weekly counseling in 3 sessions (60-90 minutes). And the control group will not receive any advice
Main outcome variables
Quality of life; Body image Concern;

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150119020719N8
Registration date: 2018-05-14, 1397/02/24
Registration timing: retrospective

Last update: 2018-05-14, 1397/02/24
Update count: 0
Registration date
2018-05-14, 1397/02/24
Registrant information
Name
Sara Esmaelzadeh Saeieh
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6007
Email address
s-esmaelzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-19, 1396/11/30
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Midwifery Counseling on postpartum Quality of Life of Primiparous Women With Body image Concerns
Public title
The Effect of Consultation on Postpartum Quality of Life in Primiparous Women with Body image Concern
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a score lower than 138 from the body image questionnaire Iranian nationality The interval betwen 6-12 months after Delivery, At least the reading and writing skills no addiction, or smoking Non-exclusive nutrition with powder milk, fluent in Persian, First pregnancy, Full Term pregnancy, Baby without anomaly, single pregnancy and live birth fetus, without pregnancy complications, (Diabetes, preeclampsia, etc.), without known medical illness and mental problems according to one's own words
Exclusion criteria:
Non-participation in 1 Full Sessions of Weekly Counseling Having hormonal problems Use of drugs Psychological problems Having burning scar or lesion on the body Body mass index more than 30
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Use the quadruple random block
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
Alborz University of Medical Sciences, Azimieh, Alborz, Iran
City
Alborz
Province
Alborz
Postal code
3186947535
Approval date
2018-01-19, 1396/10/29
Ethics committee reference number
Abzums.Rec.1396.167

Health conditions studied

1

Description of health condition studied
Quality of life after childbirth
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Body Image concern after delivery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Quality of life after childbirth
Timepoint
Before intervention, After intervention and two weeks After intervention
Method of measurement
Quality of Life Questionnaire (SF-36)

2

Description
Body Image concern after delivery
Timepoint
Before intervention, After intervention and two weeks After intervention
Method of measurement
Multidimensional Body- Self Relationship Questionnaire (MBSRQ)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The intervention group in 3 sessions (60-90) minutes will be advised. Session1: explaining the purpose of the study, Introduction, definition of body image and the problems arising from body dissatisfaction and Quality of Life, group discussion about appearance changes related to pregnancy, delivery, and postpartum; body image self-assessment tests, recommendation for exercise. Session 2: Recognizing negative body image roots; training to write daily diary of body image; training Postpartum exercise; Session 3: Reviewing Past meetings, remembering and practicing the techniques described, question and answer at the end of the session. Quality of Life Questionnaire, and Multidimensional Body- Self Relationship Questionnaire will be completed before and after the counseling sessions and two weeks later in both intervention and control groups.
Category
Behavior

2

Description
Control group: Receive routine care
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Selected health care centers of Alborz
Full name of responsible person
Sedigheh Salehi
Street address
Attached to Mehrshahr Health Center, later the crossroads of the Mellat Bank,Phase 4 of Mehrshahr, Karaj, Alborz
City
Alborz
Province
Alborz
Postal code
3186947535
Phone
+98 26 3334 0654
Email
sadighehsalehi6@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The Research choncellor Department Of Alborz University of Medical Sciences
Full name of responsible person
Mohammad Noorisepehr
Street address
The Research choncellor Department Of Alborz University of Medical Sciences, Azimieh, Alborz, Iran
City
Alborz
Province
Alborz
Postal code
3186947535
Phone
+98 26 3255 8920
Email
sadighehsalehi6@gmail.com
Grant name
Alborz University of Medical Sciences-vice President of Research
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Research choncellor Department Of 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
Sara Esmaelzadeh Saeieh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, first Golestan,Alborz
City
Alborz
Province
Alborz
Postal code
3186947535
Phone
+98 912 623 2569
Email
esmaelzadeh1360@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Sara Esmaelzadeh saieh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, first Golestan, Baghestan,Alborz, Iran
City
Alborz
Province
Alborz
Postal code
3186947535
Phone
+98 912 623 2569
Email
esmaelzadeh1360@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Sara Esmaelzadeh saieh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery,first Golestan,Alborz
City
Alborz
Province
Alborz
Postal code
3186947535
Phone
+98 912 623 2569
Email
esmaelzadeh1360@gmail.com

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 participant data can be shared after being unidentified
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
Public
Under which criteria data/document could be used
For use in studies allowed.
From where data/document is obtainable
Sedigheh Salehi, sadighehsalehi6@gmail.com
What processes are involved for a request to access data/document
The application will be sent to the project implementer by email and within 24 hours will receive the necessary items.
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