Concerning relatively high prevalence of premenstrual syndrome and its negative effects on women with this syndrome, current study aims to compare the impact of group consultation about stress management skills with that of vitamin B6 on premenstrual syndrome symptoms. The study population included students living in three dormitories of Zanjan University of Medical Sciences who suffered from moderate to acute premenstrual syndrome and were studied using a simple method. Subjects with psychiatric and mental problems were excluded using general health questionnaire (GHQ). Finally, 66 subjects with premenstrual syndrome entered the study and were randomly divided into two control and intervention groups. Interventions included four two-hour sessions for stress management skills for one group and prescribing 80 mg of vitaminB6 daily for two menstrual cycles for another intervention group. After two months, PSST questionnaire was completed by participants in order to investigate the results of interventions and the decreasing frequency of moderate and acute premenstrual syndrome and it was compared using statistical methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052127994N1
Registration date:2016-12-06, 1395/09/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-06, 1395/09/16
Registrant information
Name
Taraneh Emamgholi khooshehchin
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8318
Email address
khoosheh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of group counseling stress management skills with vitamin B6 on premenstrual syndrome
Public title
Effect of group counseling on premenstrual syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
written informed consent; suffering from moderate to acute premenstrual syndrome; having regular periods within 21-35 days intervals with 2-7 days of bleeding; obtaining a score lower than 23 in general health questionnaire; lack of known physical or psychiatric diseases according to the general health questionnaire; failure to use premenstrual syndrome treatment procedures in order to alleviate its symptoms; absence of stressful occasions such as parents’ divorce- severe financial failure- accident- death of a close relative- any surgical operations 3 months before the onset of this study; being at least 18 years old- lack of treatment of endocrine and metabolic disorders, epilepsy or any menstrual disorder from 3 months before the onset of this study; not following a special diet.
Exclusion criteria:
A terrible accident like intense family disputes- separation from parents- severe financial problems- death of a close relative during research period; being absent more than once from consultation sessions; establishment of side-effects during use of medication and being forced to withdraw it; leaving the study for any reason.
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
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
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azad Square,Zanjan
City
Zanjan
Postal code
4515613191
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
ZUMS.REC.1394.198
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
Mood symptoms of premenstrual syndrome
Timepoint
Before and two months after intervention
Method of measurement
questionnaire
2
Description
Physical symptoms of premenstrual syndrome
Timepoint
Before and two months after intervention
Method of measurement
questionnaire.
3
Description
Behavioral symptoms of premenstrual syndrome
Timepoint
Before and two months after intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The stress management’ group received four sessions of group consultation on stress management.
Category
Other
2
Description
Vitamin B6 group received 80 mg Vitamin B6 pill daily for two menstrual cycles, one week before their menstruation get started
Category
Treatment - Drugs
3
Description
No interference seen in the Control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan University of Medical Sciences
Full name of responsible person
Marzeh Eshaghi
Street address
Zanjan University of Medical Sciences,Azadi Square,Zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Doctor Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Azadi Square, Zanjan
City
Zanjan
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Taraneh Emamgoli Khooshehchin
Position
PhD
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Carmandan Boulevard,Zanjan
City
Zanjan
Postal code
Iran
Phone
+98 24 3314 8318
Fax
Email
t_khooshehchin@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)