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Evaluation of the effectiveness of midwifery counseling with the approach of acceptance and commitment on the mental image of the body and breastfeeding self-efficacy in pregnant mothers

Protocol summary

Study aim
Determining the effectiveness of midwifery counseling with an acceptance and commitment approach on body image and breastfeeding self-efficacy
Design
The clinical trial is a parallel type with two arms, one is the intervention group and the other is the control group. It is performed on 90 pregnant women who are eligible for the study. Block method with a volume of 4 to 45 people in the control group and 45 people in the intervention group are allocated.
Settings and conduct
90 pregnant women with inclusion criteria were included in the study from 8 comprehensive health service centers in Jajarm city and its suburbs, and randomly, 45 people were in the control group and 45 people were in the intervention group. The intervention group will then receive 8 sessions of admission-based counseling. The control group will receive only routine care. At the end of the counseling sessions, one month and three months after delivery, the questionnaires are completed by both groups and then the data analysis is performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: First pregnancy, gestational age 28 to 32 weeks, decision to exclusive breastfeeding, obtaining a cut-off score in the questionnaire, no smoking, no pregnancy problems, no major psychiatric illness Inclusion criteria: Not available to pregnant mothers
Intervention groups
The intervention group, at separate times, receives 8 sessions of counseling based on acceptance and commitment in such a way that the first 4 sessions twice a week and the second 4 sessions once a week receive 10 people in each session for 90 minutes. The control group only Will receive routine care.
Main outcome variables
The first initial consequence is the mental image of the body. The second primary consequence is the self-efficacy of breastfeeding.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210123050116N1
Registration date: 2021-03-04, 1399/12/14
Registration timing: prospective

Last update: 2021-03-04, 1399/12/14
Update count: 0
Registration date
2021-03-04, 1399/12/14
Registrant information
Name
Maryam sadat Hosini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3250 6146
Email address
hosinisadat370@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-11-06, 1400/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of midwifery counseling with the approach of acceptance and commitment on the mental image of the body and breastfeeding self-efficacy in pregnant mothers
Public title
Evaluation of the effectiveness of acceptance and commitment counseling on body image and breastfeeding self-efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
First pregnancy Single pregnancy Gestational age 28 to 32 weeks Decided to exclusive breastfeeding Obtain a cut-off score on the Multidimensional Body-Self Relationships Questionnaire At least literacy Familiarity with cyberspace No addiction to cigarettes, drugs and alcohol No problems during pregnancy (including pre Aklamsya, placenta previa, diabetes, Dklman) The lack of major psychiatric disease Lack of breast abnormalities Lack of medical prohibition on breastfeeding for mother and baby Previous non-participation in courses similar to this course Having the consent to enter the study Resident of Jajarm city and its suburbs
Exclusion criteria:
Absence for more than two sessions Relocation and unavailability of pregnant mothers
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Using the allocation sequence generated from the website www.sealedenvelope.com and based on the 4-volume block method, participants are randomly assigned to two groups. Because people enter the study over time and because This method was used over time to assign a proportion to the groups by accident, and also by assigning one person to a group, it is not possible to guess which group the next person will belong to. After generating the allocation sequence, each sequence letter (A, B) corresponds to a group. Since the participants enter the study from different centers, the central concealment method is used. The allocation sequence is in the hands of someone outside the research team. For each eligible person, after registering and entering the study, the desired person will be contacted and thus entered in a central list and will receive an identification code and assigned to the desired 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
Research Ethics Committee of Shahroud University of Medical Sciences
Street address
Shahroud, Haftam Tir Square, Shahroud University of Medical Sciences and Health Services
City
Shahrood
Province
Semnan
Postal code
36147-73947
Approval date
2021-02-07, 1399/11/19
Ethics committee reference number
IR.SHMU.REC.1399.165

Health conditions studied

1

Description of health condition studied
The effectiveness of midwifery counseling with acceptance and commitment approach on body image and breastfeeding self-efficacy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The score of the mental image of the body in the multidimensional body-self relations questionnaire
Timepoint
At the beginning of the study (before the intervention) and immediately after the intervention, one month and three months after delivery
Method of measurement
Based on the standard body-self multidimensional relationship questionnaire, which has 68 Likert-scale questions, each question is scored from 1 (completely dissatisfied) to 5 (completely satisfied), so the minimum total score of an individual 68 and the maximum total score of a person can be 340. The scoring of the questionnaire is such that people who have a more appropriate mental image of themselves get higher scores. The cut-off score in this questionnaire is 142.

2

Description
Breastfeeding self-efficacy score in the standard breastfeeding self-efficacy questionnaire
Timepoint
At the beginning of the study (before the intervention) and immediately after the intervention, one month and three months after delivery
Method of measurement
Based on the standard breastfeeding self-efficacy questionnaire, which has 33 options and is rated on a 5-point Likert scale from strongly agree (score 5) to strongly disagree (score 1). Scores range from 33 to 165, and higher scores indicate higher levels of breastfeeding self-efficacy. A score of 33 to 76 is considered low self-efficacy, a score of 77 to 120 is considered moderate self-efficacy and a score of 121 to 165 is considered high self-efficacy.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: At separate times, 8 sessions of counseling based on acceptance and commitment (in case of outbreak of Covid disease 19 virtually) so that the first 4 sessions twice a week and the second 4 sessions once a week, 10 sessions in each session for They receive 90 minutes at the training hall of the same comprehensive health service center. The content of the meetings is based on the protocol of acceptance and commitment based on the six processes (acceptance, failure, self as a context, living in the present, recognizing values and committed action). These meetings will be held professionally by the project manager.
Category
N/A

2

Description
Control group:Receives only routine care, and at the end (a placebo intervention) is formed as a training session for the control group to maintain ethical standards that does not interfere with the counseling intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive health service centers of Jajarm city and its suburbs
Full name of responsible person
Maryam Sadat Hosseini
Street address
Imam Reza Boulevard, Jajarm Health Network
City
Jajarm
Province
North Khorasan
Postal code
9431148348
Phone
+98 58 3227 6014
Email
hosinisadat370@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hassan Emamian
Street address
3rd Floor, Bahar Research Center, Bahar Haspital, In front of Children's Park, 22 Bahman Ave.
City
Shahroud
Province
Semnan
Postal code
3615739121
Phone
+98 23 3239 6714
Fax
+98 23 3239 4852
Email
emamian@shmu.ac.ir
Web page address
http://www.shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Maryam sadat Hosini
Position
Student superior council in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Side Passage Votary, Banke Mellat, Department Central, Street Martyr Artistic
City
Jajarm
Province
North Khorasan
Postal code
9431148348
Phone
+98 58 3250 6146
Fax
Email
hosinisadat370@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Maryam sadat Hosini
Position
Student superior council in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Side Passage Votary, Banke Mellat, Department Central, Street Martyr Artistic
City
Jajarm
Province
North Khorasan
Postal code
9431148348
Phone
+98 58 3250 6146
Fax
Email
hosinisadat370@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Maryam sadat Hosini
Position
Student superior council in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Side Passage Votary, Banke Mellat, Department Central, Street Martyr Artistic
City
Jajarm
Province
North Khorasan
Postal code
9431148348
Phone
+98 58 3250 6146
Fax
Email
hosinisadat370@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 data can be shared after identifying the names of individuals.
When the data will become available and for how long
Access period starts four months after the results are registered
To whom data/document is available
Researchers and students of medical universities
Under which criteria data/document could be used
The use of documents in all scientific and research activities is allowed, and to send a request for access to data and documents must be a student or researcher in the country's medical universities.
From where data/document is obtainable
To receive data, send an email to this address: hosinisadat370@gmail.com
What processes are involved for a request to access data/document
The student or researcher will send an email with the full content of the reason for requesting and using the data to the email mentioned, and it will be sent to them as soon as they see the email.
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