Examine the effect of problem-solving skill training on marital satisfaction among primiparous breastfeeding mothers.
Design
Randomized controlled trial
Settings and conduct
This two-group pretest-posttest randomized controlled trial was held in 2015 on 68 primiparous breastfeeding mothers who referred to healthcare centers located in Babol, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Had a childbirth at 37th–42nd weeks of their pregnancy at least two months before the study.
- Had a low-to moderate marital satisfaction based on the results of the ENRICH questionnaire.
- Did not divorce.
- Possessed basic literacy skills.
- Only wife of her husband.
- Had a married life of 1–10 years.
- Did not have a baby with major congenital anomalies.
- Had a planned pregnancy.
- Neither experienced any serious stressful life event during the past three months prior to the study nor suffered from post-natal depression and psychosis.
- Lack of serious mental and physical illness (cancer) and advanced chronic diseases.
- Had no addiction to opioids, psychoactive agents, and alcohol among the mothers or their husbands.
exclusion criteria
- Failure to respond to more than 5% of the items of the study questionnaire.
- Voluntary withdrawal from the study.
- Two or more absences from training sessions.
- Development of serious health conditions or undergoing any type of surgery during the study.
- Participation in any personal or group psychotherapy programs during the study.
- A second pregnancy during the study.
Intervention groups
intervention group: problem solving skill training in six 80-minute sessions
comparison group: Not receiving problem solving skill training
Main outcome variables
problem solving skill training on marital satisfaction.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171209037794N2
Registration date:2018-10-04, 1397/07/12
Registration timing:retrospective
Last update:2018-10-04, 1397/07/12
Update count:0
Registration date
2018-10-04, 1397/07/12
Registrant information
Name
Parvaneh Mirabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 7958
Email address
parvaneh_mirabi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-08-03, 1394/05/12
Expected recruitment end date
2016-03-10, 1394/12/20
Actual recruitment start date
2015-08-05, 1394/05/14
Actual recruitment end date
2016-04-10, 1395/01/22
Trial completion date
2017-04-10, 1396/01/21
Scientific title
Problem-solving skill training and marital satisfaction: A study among primiparous breastfeeding mothers
Public title
Problem-solving skill training and marital satisfaction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Had a childbirth at 37th–42nd weeks of their pregnancy at least two months before the study.
Had a low-to moderate marital satisfaction based on the results of the ENRICH questionnaire.
Did not divorce.
Possessed basic literacy skills.
Only wife of her husband
Had a married life of 1–10 years.
Did not have a baby with major congenital anomalies.
Had a planned pregnancy.
Neither experienced any serious stressful life event during the past three months prior to the study nor suffered from post-natal depression and psychosis.
Lack of serious mental and physical illness (cancer) and advanced chronic diseases.
Had no addiction to opioids, psychoactive agents, and alcohol among the mothers or their husbands.
Exclusion criteria:
Failure to respond to more than 5% of the items of the study questionnaire.
Voluntary withdrawal from the study.
Two or more absences from training sessions.
Development of serious health conditions or undergoing any type of surgery during the study.
Participation in any personal or group psychotherapy programs during the study.
A second pregnancy during the study.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
68
Actual sample size reached:
68
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 68 breastfeeding mothers were randomly divided into two groups receiving problem solving skill training (intervention group) or comparison group, based on the blocked randomization with a block size of 4for the two groups
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 Golestan University of Medical Sciences
Street address
Gorgan Road to Sari, Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2015-08-03, 1394/05/12
Ethics committee reference number
Ir.goums.rec.1394.75
Health conditions studied
1
Description of health condition studied
Low to moderate marital satisfaction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Comparison marital satisfaction and its dimensions before and after problem solving skill training in experimental and comparison groups
Timepoint
before the intervention, immediately after the intervention and one month afterwards.
Method of measurement
ENRICH questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Problem solving skill training in the intervention group was provided in six 80-minute sessions, in 10–11-person groups.Training sessions focused mainly on breastfeeding-related problems. All sessions were held in one of the recruited healthcare centers which had better training facilities. All mothers in both groups completed the ENRICH inventory before the intervention, immediately after the sixth training session for the mothers in the experimental group, and one month afterwards.Different content at each session include: The first session: Familiarization of group members with each other; definition of life skills and PSS and the necessity for their training; emotion- and problems-focused coping; emotions and the importance of their management; the phases of PSS; The first step of problem solving (orientation to a problem). The second session: ways to improve orientation to the problem. The third session: the second step of problem solving (clear definition of the problem). The fourth session: The third step of problem solving (generating different solutions to the problem) and the fourth step of problem solving (eliminating unfeasible and irrational solutions and selecting the best one). The fifth session: The use of the ‘advantages-disadvantages’ technique for selecting the best solution. The fifth step of problem solving (implementation and reassessment of the solution). The sixth session: using the steps of problem solving for a selected problem; giving the posttest; determining the time for the next posttest at one month after the intervention.
Category
Behavior
2
Description
Control group: Mothers in the comparison group received no training.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
healthcare centers of Babol University of Medical Sciences
Full name of responsible person
Fatemeh Abedi
Street address
Babol University of Medical Sciences, Ganj Afrooz Avenue, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9594
Email
Fatemeabedi215@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad reza Honarvar
Street address
Gorgan Road to Sari, Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 71 3245 1660
Email
honarvar@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Fatemeh Abedi
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Gorgan Road to Sari, Golestan University of Medical Sciences
City
Gogan
Province
Golestan
Postal code
4918936316
Phone
+98 11 3221 0056
Email
Fatemeabedi215@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Fatemeh Abedi
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Gorgan Road to Sari, Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 11 3221 0056
Email
Fatemeabedi215@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Fatemeh Abedi
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Gorgan Road to Sari, Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 11 3221 0056
Email
Fatemeabedi215@gmail.com
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
All rights related to the data is for golestan University of Medical Sciences.
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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data will be shared after making characteristics of the persons, unrecognizable.
When the data will become available and for how long
Initiation of the data availability 6 months after publication of the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Using in the systematic review and meta-analysis
From where data/document is obtainable
Golestan University of Medical Sciences
What processes are involved for a request to access data/document
Providing a request and receiving the university approval letter