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The effect of intervention based on the theory of planned behavior on the breastfeeding pattern of mothers with preterm infants hospitalized in selected hospitals in Isfahan in 2021

Protocol summary

Study aim
Determining the effect of intervention based on the theory of planned behavior on the breastfeeding pattern of mothers with preterm infants hospitalized in selected hospitals in Isfahan in 2021
Design
Field trial study (with control and intervention group) with parallel groups, 72 participants and randomized
Settings and conduct
The research will be conducted in two groups of intervention and control. Pre-test in both groups is done by a researcher-made questionnaire. Training for the intervention group is provided in 4 sessions (each session for 60 to 90 minutes) through lectures, brainstorming, role-playing, training videos and pamphlets. The intervention and control groups will be followed for 4 months. Post-test will be performed immediately, 2 and 4 months after the intervention by completing a researcher-made questionnaire.
Participants/Inclusion and exclusion criteria
The baby is the result of a single pregnancy, mother's literacy, neonatal hospitalization due to preterm, Having Iranian nationality, living in Isfahan, no maternal and neonatal contraindications for breastfeeding
Intervention groups
During the research, the control and intervention group will receive the usual care and training by the researcher, and in addition, the intervention group will participate in 4 training sessions based on the theory of planned behavior.
Main outcome variables
Attitude score, Subjective norms, perceived behavioral control, behavioral intention; Breastfeeding pattern type

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210524051392N1
Registration date: 2021-06-13, 1400/03/23
Registration timing: prospective

Last update: 2021-06-13, 1400/03/23
Update count: 0
Registration date
2021-06-13, 1400/03/23
Registrant information
Name
Shirin Okhovat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3338 2219
Email address
shirinokhovat98@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intervention based on the theory of planned behavior on the breastfeeding pattern of mothers with preterm infants hospitalized in selected hospitals in Isfahan in 2021
Public title
Breastfeeding pattern
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a desire to participate in the study Having literacy Having Iranian nationality Having a stable condition for the baby to start breastfeeding according to the doctor's instructions (no cyanosis, tachypnea, tachycardia) The baby is the result of a single pregnancy The gestational age according to the case documents is 34 to 36 weeks and 6 days Permanent marriage of the infant's parents Living in Isfahan
Exclusion criteria:
Using a surrogacy Employing mother in the medical and paramedical professions Having contraindications to breastfeeding according to medical records Presenting disorder affecting breastfeeding in the baby's mouth and tongue Having psychiatric problems and taking antidepressants based on the case document and the mother's statement Mother addiction based on dossier medical
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are divided into two groups of control or intervention based on simple random allocation method. In order to randomize, the researcher will put two samples of cards, which in one page two word “control” and in other page the word “intervention” is written, in a large envelope, and asked participants to choose one of them without observing the cards in the envelope, which is determined according to the selected order of the participants participating in the test or 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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib St.,
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-05-24, 1400/03/03
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.012

Health conditions studied

1

Description of health condition studied
Breastfeeding pattern
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Attitude score in a researcher-made questionnaire in two groups of intervention and control
Timepoint
Complete the questionnaire before, immediately, 2 and 4 months after the intervention
Method of measurement
Researcher-made questionnaire

2

Description
The score of mental norms in a researcher-made questionnaire in two groups of intervention and control
Timepoint
Complete the questionnaire before, immediately, 2 and 4 months after the intervention
Method of measurement
Researcher-made questionnaire

3

Description
Perceived behavioral control score in a researcher-made questionnaire in two groups of intervention and control
Timepoint
Complete the questionnaire before, immediately, 2 and 4 months after the intervention
Method of measurement
Researcher-made questionnaire

4

Description
Behavior intention score in a researcher-made questionnaire in two groups of intervention and control
Timepoint
Complete the questionnaire before, immediately, 2 and 4 months after the intervention
Method of measurement
Researcher-made questionnaire

5

Description
Frequency of lactation pattern in two groups of intervention and control
Timepoint
Ask questions before, immediately, 2 and 4 months after the intervention
Method of measurement
ask question

Secondary outcomes

1

Description
Neonatal growth indices (height, weight, head circumference) between the intervention and control groups
Timepoint
Measurement of indicators before, immediately, 2 and 4 months after the intervention
Method of measurement
Meters / scales

Intervention groups

1

Description
Intervention group: Holding 4 session that it takes about 60-90 minutes and they include: expressing the positive consequences of breastfeeding and playing an educational video on proper breastfeeding, training on breastfeeding ability and holding sessions based on gaining the support of others in breastfeeding, training on barriers to breastfeeding and solving problems in this regard.
Category
Behavior

2

Description
Control group: Receive routine care and training by the researcher.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Shirin Okhovat
Street address
Ostad Motahari St., metal bridge
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3236 7001
Fax
+98 31 3236 4210
Email
beheshti@mui.ac.ir
Web page address
https://beheshti.mui.ac.ir/

2

Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Shirin Okhovat
Street address
Ibn Sina Street, Shohada Square
City
Esfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3445 5051
Email
amin@mui.ac.ir
Web page address

3

Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Shirin Okhovat
Street address
Sefeh Boulevard, Shahid Keshvari Highway
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
alzahra@mui.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoy Javanmard
Street address
Isfahan University of Medical Sciences, Hezar Jerib St.
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3792 3060
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shirin Okhovat
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 18, Alley 10, Shams Tabrizi Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817936363
Phone
+98 38 3338 2198
Email
shirinokhovat95@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojgan Jani Ghorban
Position
Assistant Professor of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Isfahan University of Medical Sciences, Hezar Jerib St.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 2914
Email
janighorban@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirin Okhovat
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 18, Alley 10, Shams Tabrizi Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817936363
Phone
+98 38 3338 2198
Email
shirinokhovat95@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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