Protocol summary

Study aim
A comparative study on the effect of self-awareness and problem-solving skills training on marital satisfaction of married women referring to health centers in Gorgan, 2019
Design
Clinical Trial with parallel group, Single blind, randomization
Settings and conduct
In this experimental study, pre-test and post-test with control group, 120 married women who spend up to 5 years of their life together and receive Pap smears and care for infants' care or vaccination. They will be selected, randomly divided into two intervention groups and one control group.
Participants/Inclusion and exclusion criteria
All women of childbearing age with a cohabitation of 6 months to 5 years
Intervention groups
Women in intervention group 1 participated in self-awareness training sessions and women in intervention group 2 participated in problem solving skills training and the control group did not receive any intervention.
Main outcome variables
marital satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190721044290N1
Registration date: 2020-12-24, 1399/10/04
Registration timing: retrospective

Last update: 2020-12-24, 1399/10/04
Update count: 0
Registration date
2020-12-24, 1399/10/04
Registrant information
Name
Saba Moodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3225 8357
Email address
mw.moodi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the Effect of Self-awareness and Problem-solving Skills Training on Marital Satisfaction of Married Women
Public title
"The Effect of Self-awareness Skill Training on Marital Satisfaction of Married Women" "The Effect of Problem-solving Skill Training on Marital Satisfaction of Married Women"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Residing in Gorgan High school education and higher The marriage being permanent The first marriage of each couple The duration of marriage (cohabitation under one roof) is six months to five years Reproductive age Earn less than the quorum of the Enrich Marital Satisfaction Questionnaire
Exclusion criteria:
Surgical history of hysterectomy, ophorectomy Existence or history of malignancies of the reproductive system (uterus, ovaries) and breasts Chronic medical conditions (such as diabetes, kidney (dialysis), multiple sclerosis) or debilitating diseases Nervous and mental illnesses such as anxiety and depression or the use of medications associated with it Studying psychology, counseling and attending other psychotherapy sessions A history of infertility Addicting each couple History of the accident in the past six months Menopause
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are asked to complete the informed consent form to participate in the research, the Enrich Marital Satisfaction Questionnaire, the Self-Awareness Questionnaire, and the Problem Solving Questionnaire. Then based on the marital satisfaction score, the block allocation will be done by random method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Based on the marital satisfaction score, the researcher will perform randomized block allocation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Gorgan University of Medical Sciences
Street address
first Shastkola road, Gorgan
City
Gorgan
Province
Golestan
Postal code
1
Approval date
2019-09-21, 1398/06/30
Ethics committee reference number
IR.GOUMS.REC.1398.187

Health conditions studied

1

Description of health condition studied
marital satisfaction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Marital satisfaction score in the Enrich Marital Satisfaction Questionnaire
Timepoint
Before intervention, immediately and one month after intervention
Method of measurement
Enrich Marital Satisfaction Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Behavior

2

Description
Intervention group:
Category
Behavior

3

Description
Control group:
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Golha Health Center
Full name of responsible person
Saba Moodi
Street address
No. 1 Golbarg Alley, Golha Street
City
Gorgan
Province
Golestan
Postal code
4915643316
Phone
+98 17 3215 8236
Email
midwife.moodi@ymail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr GH Roshandel
Street address
No. 10, Tahmasebi AVE, Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4919655481
Phone
+98 17 3245 8056
Email
midwife.moodi@ymail.com
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
Saba Moodi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 10, Tahmasebi AVE, Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4919655481
Phone
+98 17 3245 8056
Email
midwife.moodi@ymail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Saba Moodi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 10, Tahmasebi AVE, Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4919655481
Phone
+98 17 3245 8056
Email
midwife.moodi@ymail.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Saba Moodi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 10, Tahmasebi AVE, Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4919655481
Phone
+98 17 3245 8056
Email
midwife.moodi@ymail.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
Individual data can be shared after unidentifiable.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
researchers
Under which criteria data/document could be used
researchers
From where data/document is obtainable
midwife.moodi@ymail.com
What processes are involved for a request to access data/document
midwife.moodi@ymail.com
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