Study of the effectiveness of happiness training on quality of life and negative and positive affection in women with premenstrual syndrome: a randomized controlled clinical trial
To determine the effectiveness of happiness training on quality of life and negative and positive affection in women with premenstrual syndrome
Design
Two-armed randomized controlled trial
Settings and conduct
This study will be conducted on women referring to Shahid Babaie Health Center of Tabriz. The researcher will refer to health center and will select women with age of 15 to 49 years according to their records, then will call them and they will be invited to participate in the study. In face to face session, the women who obtain a premenstrual syndrome score of over 28 (average and high score) will be included in study and written consent will be obtained. Then questionnaires of socio-demographic information, quality of life and positive and negative affection will be completed by the participants. Participants will be randomly assigned into two groups of counseling and control through block randomization. For the intervention group, educational counseling will be provided using the Fordyce method in eight 120-minute sessions. At the last session, the questionnaires will be completed again by the participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women who have symptoms of premenstrual syndrome with a normal menstrual cycle
Exclusion criteria: History of physical illness; Personality or mood disorders
Intervention groups
For the intervention group, educational counseling will be provided using the Fordyce method in eight 120-minute sessions.The control group will receive routine cares.
Main outcome variables
Quality of life and negative and positive affection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N47
Registration date:2018-12-08, 1397/09/17
Registration timing:registered_while_recruiting
Last update:2018-12-08, 1397/09/17
Update count:0
Registration date
2018-12-08, 1397/09/17
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-31, 1397/08/09
Expected recruitment end date
2018-12-30, 1397/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effectiveness of happiness training on quality of life and negative and positive affection in women with premenstrual syndrome: a randomized controlled clinical trial
Public title
The effectiveness of happiness training on quality of life and negative and positive affection in women with premenstrual syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women who have symptoms of premenstrual syndrome
Having age between 15 to 48
Having at least secondary education
Having a normal menstrual cycle (21-35 days).
Exclusion criteria:
History of physical illness
Taking psychoactive drugs
Suffering from personality disorder and mood disorders
Age
From 15 years old to 48 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be conducted using the website www.random.org and through blocking with block sizes of four and six and an allocation ratio of 1: 1 to the two groups of education and control.
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 Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2018-09-24, 1397/07/02
Ethics committee reference number
IR.TBZMED.REC.1397.540
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
Negative and positive affection
Timepoint
Before intervention, eight weeks after the intervention
Method of measurement
Negative and positive affection questionnaire
2
Description
Quality of life
Timepoint
Before intervention, eight weeks after the intervention
Method of measurement
Quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
For the intervention group, eight 120-minute sessions of group counseling once a week will be provided.
Category
Treatment - Other
2
Description
The control group will receive routine cares.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Babaei Health Center
Full name of responsible person
Khadije Hajizadeh
Street address
South Shariati
City
Tabriz
Province
East Azarbaijan
Postal code
56541-51338
Phone
+98 41 3479 6770
Email
hajizade_k@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6969
Email
mirghafourvandm@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Hajizadeh Khadije
Position
Ph.D student of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
56541-51338
Phone
+98 41 3479 6770
Email
hajizade_k@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
56541-51338
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hajizadeh Khadije
Position
Ph.D student of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
56541-51338
Phone
+98 41 3479 6770
Email
hajizade_k@yahoo.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