Protocol summary
-
Study aim
-
The Effect of couples counseling on improving breastfeeding in women with unwanted pregnancies
-
Design
-
Phase 3 of a randomized clinical trial, has a control group with parallel groups. That will be performed on 60 couples(30 Interventions and 30 Control). We do not have blinding. Eligible women will be selected by convenience sampling method and will be assigned to two intervention and control groups using 4 random blocks.
-
Settings and conduct
-
Sampling will be done from four health centers In Zanjan city. Sixty eligible couples will be selected using the convenience method then they will be allocated into the intervention and control groups based on the four block design. The number of blocks will be selected from the random number table.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Obtaining less than 3 scores based on the London unplanned pregnancies questionnaire; gestational age 36-34 weeks ; obtaining a score of 18-36 based on the Cohen perceived stress questionnaire.
Exclusion Criteria: Breastfeeding contraindication; absence of more than two sessions in counseling sessions;not desire to continue participation; simultaneous participation in similar training classes, history of known mental disorder, history of chronic debilitating illness
-
Intervention groups
-
The Intervention Group Six sessions of breastfeeding counseling will beheld using Bandura self-efficacy approach with the participation of couples. It will be Individually, Twice a week and each session for 45 to 60 minutes.
The control group will only receive routine care.
-
Main outcome variables
-
Breastfeeding Self-efficacy In Unwanted Pregnancy
General information
-
Reason for update
-
Change the sampling date
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20150731023423N18
Registration date:
2020-11-09, 1399/08/19
Registration timing:
prospective
Last update:
2020-11-28, 1399/09/08
Update count:
1
-
Registration date
-
2020-11-09, 1399/08/19
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-11-10, 1399/08/20
-
Expected recruitment end date
-
2021-02-19, 1399/12/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The Effect of couples counseling on improving of breastfeeding among women with unwanted pregnancy
-
Public title
-
The Effect of couples counseling on improving of breastfeeding among women with unwanted pregnancy
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
A score of less than 3 based on the London unplanned pregnancy scale
Gestational age 36-34 weeks
Score 18-36 based on the Cohen perceived stress questionnaire
Exclusion criteria:
Breastfeeding contraindication
Absence in counseling sessions more than two sessions
Not desire to continue the participation
Simultaneous participation in similar training classes
History of known mental disorder
History of chronic debilitating disease
-
Age
-
No age limit
-
Gender
-
Female
-
Phase
-
3
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
60
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Eligible women will be selected using the convenience sampling method. According to the sample size, they will be randomly allocated to the intervention and control groups using randomized 4-Block by table of random number.The sequence of blocks will be placed on a separate sheet inside the matte envelope. In the present study, we do not have blinding.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-07-16, 1399/04/26
-
Ethics committee reference number
-
IR.ZUMS.REC.1399.137
Health conditions studied
1
-
Description of health condition studied
-
Unplanned Pregnancy
-
ICD-10 code
-
-
ICD-10 code description
-
Primary outcomes
1
-
Description
-
Breastfeeding Self-efficacy
-
Timepoint
-
Before ; Immediately After The Consultation Sessions; Six Weeks After Delivery
-
Method of measurement
-
Dennis Breastfeeding Self-Efficacy Questionnaire
Secondary outcomes
1
-
Description
-
Stress is perceived
-
Timepoint
-
Before immediately after the consultation sessions and six weeks after delivery
-
Method of measurement
-
Cohen Perceived Stress Questionnaire
Intervention groups
1
-
Description
-
Intervention group will be received 6 sessions of couples counseling according to the Bandura' Self-efficacy Protocol, twice a week and each session for 45 to 60 Minutes. The Content of the sessions includes: breastfeeding self-efficacy, factors Affecting of breastfeeding self-Breastfeeding education, discussion about couples' attitudes toward pregnancy, accepting unwanted pregnancies, the role of spouse participation in controlling women's emotions and stress, self-efficacy and its role in breastfeeding, anti-self-efficacy drug, emotion management, improving attitudes toward pregnancy, the role of spouse participation Breastfeeding.efficacy, emotion management in dealing with breastfeeding and pregnancy related stressors, attitudes toward pregnancy, increasing spouse participation in stress management and breastfeeding.
-
Category
-
Prevention
2
-
Description
-
Pregnancy routine care control group that will receive 8 routine sessions during pregnancy, including nutrition, breastfeeding, personal hygiene, etc.
-
Category
-
Prevention
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Zanjan 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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
Possibility of dissatisfaction of participants
-
Study Protocol
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available