The effect of Fordyce happiness training on marital satisfaction and mental health in women with premenstrual syndrome
Design
This study is a not blinded clinical trial. The study population will be included all women with the premenstrual syndrome who will refer to private clinics in Kermanshah city.40 eligible patients will be selected conveniently and randomly assigned to intervention and control groups.
Settings and conduct
This study, which will be conducted at Kermanshah private clinics of obstetrics and gynecology and not blinded. Patients with the premenstrual syndrome will be in two intervention and control groups and the intervention group will receive cognitive-behavioral counseling based on the principles of happiness.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The menstrual period between 35-21 in the six recent periods; At least 5 years have passed since marriage
Exclusion criteria: No-participation in two or more sessions of training sessions; Acute or chronic physical and mental illnesses
Intervention groups
The intervention group will receive a cognitive-behavioral counseling based on the principles of Fordey's Happiness in six sessions of 60-90 minutes, with a 7-day interval.
The control group will not receive any training
Main outcome variables
Marital satisfaction; Mental health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N94
Registration date:2018-06-12, 1397/03/22
Registration timing:registered_while_recruiting
Last update:2018-06-12, 1397/03/22
Update count:0
Registration date
2018-06-12, 1397/03/22
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Fordyce happiness training on marital satisfaction and mental health in women with premenstrual syndrome
Public title
Effect of happiness training on marital satisfaction and mental health in women with premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Score 20 and above of the premenstrual syndrome screening questionnaire
Score lower than 142 of the shortened questionnaire (47 questions) Enrich marital satisfaction
Score 22 to 42 of the Goldberg Mental Health Questionnaire
The menstrual period is between 35-21 in the six recent periods
At least 5 years have passed since marriage
Exclusion criteria:
Non-participation in two or more sessions of training sessions
Acute or chronic physical and mental illnesses
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation (Individually) using random numbers table through of receiving code
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-05-08, 1397/02/18
Ethics committee reference number
ir.kums.rec.1397.047
Health conditions studied
1
Description of health condition studied
Premenstrual Syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Marital Satisfaction
Timepoint
The beginning of the study, the end of the study, and 45 days after the end of the study
Method of measurement
Using Enrich Marital Satisfaction Questionnaire
2
Description
Mental Health
Timepoint
The beginning of the study, the end of the study, and 45 days after the end of the study
Method of measurement
Using Mental Health Questionnaire (GHQ-28)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive a cognitive-behavioral counseling based on the principles of Fordey's Happiness in six sessions of 90-60 minutes, with a 7-day interval.
Category
Behavior
2
Description
The control group will not receive any training
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Personal office
Full name of responsible person
Fereshteh Abdolrahmi
Street address
Municipal Parking
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 6774
Email
A.fereshteh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Fereshteh Abdolrahmi
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
A.Fereshteh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Marzieh Kaboudi
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Reproductive Health
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
fkoboudim@kums.as.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fereshteh Abdolrahmi
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
A.Fereshteh@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 25-day period, the documents will be sent e-mail