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Comparing the effect of self-efficacy counselling and routine care on self-efficacy of breast-feeding in women with gestational diabetes

Protocol summary

Study aim
Evaluation of counselling on self-efficacy of breast-feeding in women with gestational diabetes
Design
This study is parallel, double blind clinical trial. A total of 100 mothers with gestational diabetes hospitalized at Emam Khomeini hospital, in Arak will be enrolled in this study. We will divide patients in 2 groups by simple randomization.
Settings and conduct
In this study, a total of 100 mothers with gestational diabetes hospitalized at Emam khomeini hospital in Arak will be enrolled in this study. This clinical trial is double blind in which outcome assessor and analyzer don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant mothers with gestational diabetes, being at the age of 18 to 40 years, single pregnancy, first and second births. Non-inclusion criteria: Lack of consent to participate in the study, infant hospitalized for more than 12 hours, infant with congenital malformations or metabolic disorders, illiterate mothers, severe postpartum complications, having prohibition of lactation.
Intervention groups
The intervention group will receive self-efficacy sessions as GATHER counseling in 6 sessions that will receive 2 sessions in the third trimester of pregnancy (first session between 32 to 33 weeks and the second session between 35 to 36 weeks and 4 postpartum sessions with intervals of 14 to 16 days, 28 to 30 days, two months and three months after delivery respectively). The control group will also receive routine care.
Main outcome variables
Self-efficacy, proper weight-bearing, fissure, mastitis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N139
Registration date: 2020-04-02, 1399/01/14
Registration timing: registered_while_recruiting

Last update: 2020-04-02, 1399/01/14
Update count: 0
Registration date
2020-04-02, 1399/01/14
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of self-efficacy counselling and routine care on self-efficacy of breast-feeding in women with gestational diabetes
Public title
The effect of counselling on self-efficacy of breast-feeding in gestational diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant mothers with gestational diabetes Ages 18 to 40 years Single pregnancy First and second births
Exclusion criteria:
Lack of consent to participate in the study Infant hospitalized for more than twelve hours Infant with congenital malformations or metabolic disorders Illiterate mother Severe postpartum complications Having prohibition of lactation
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization; randomization with envelopes and allocating into two groups A and B. In this method, we select a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards are mixed. One card is taken out and its ‎allocation is registered and the card is returned to the box near other cards. Then the cards ‎are mixed again and we take out another card. This process continues to reach a random sequence ‎according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind). Outcome assessor and analyzer don't aware from grouping. Groups are named as A and B and will be available to analyzer and outcome assessor using these codes
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij square ,Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-09-22, 1398/06/31
Ethics committee reference number
IR.ARAKMU.REC.1398.181

Health conditions studied

1

Description of health condition studied
Gestational diabetes
ICD-10 code
O24.4
ICD-10 code description
Gestational diabetes mellitus

Primary outcomes

1

Description
Self-efficacy of breast-feeding
Timepoint
Before consultation and then every month until 4 months later
Method of measurement
Self-efficacy of breast-feeding questionnaire

2

Description
neonate weight gain
Timepoint
Before consultation and then every month until 4 months later
Method of measurement
Scale

3

Description
Catching fissure
Timepoint
Before consultation and then every month until 4 months later
Method of measurement
Physical examination

4

Description
Mastitis
Timepoint
Before consultation and then every month until 4 months later
Method of measurement
Physical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will receive self-efficacy sessions as GATHER counseling in 6 sessions that will receive 2 sessions in the third trimester of pregnancy (first session between 32 to 33 weeks and the second session between 35 to 36 weeks and 4 postpartum sessions with intervals of 14 to 16 days, 28 to 30 days, two months and three months after delivery).
Category
Treatment - Other

2

Description
Control group: The control group will also receive routine care.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Dr Katayon Vakilian
Street address
Imam Khomeini Hospital, South Belt Road in front of Razavi town
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3278 2021
Email
catty.v@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Mahbobeh Khorsandi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Midwifery and nursing department, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Fax
Email
khorsandi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Katayon Vakilian
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Midwifery and nursing department, Payambar Azam complex, Basij sqaure, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Fax
Email
cattyv@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Rezvan Purghasemian
Position
Master student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
rez1.pourghasemian@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
Data results
When the data will become available and for how long
After the article is published
To whom data/document is available
Researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Dr Katayon Vakilian
What processes are involved for a request to access data/document
They have to write letters to the professors and the university
Comments
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