Comparing the effects of relaxation and vitamin B6 on premenstrual syndrome, this clinical trial study will conduct that aim to compare the effect of relaxation and vitamin B6 on premenstrual syndrome on girls living in dormitory of Rafsanjun University of Medical Sciences. According to the inclusion criteria aged 18 to 25 years; normal menstruation (3 to 8 days of bleeding, and interval between two cycles of 26 to 31 days); no history of use of antidepressants, tranquilizers or hormones, and no crises (loss of dear ones, divorce, …), 250 girls will select and randomly assign to three groups (vitamin B6 recipients, relaxation trainee and control groups). Relaxation trainee group participate in two training sessions and will ask to do relaxation techniques every day a week before their menstruation. Also, the group receiving vitamin B6 will be asked to start 80 mg vitamin B6 pill three times per week from one week prior to the start of their menstruation. In the control group, there will not be any interference.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070518357N1
Registration date:2014-11-24, 1393/09/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-24, 1393/09/03
Registrant information
Name
Nahid Hassani
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 39 1522 3363
Email address
a_ansari@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2014-01-20, 1392/10/30
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial Comparing the effect of relaxation and vitamin B6 on pre-menstrual syndrome in dormitories
Public title
Comparing the effect of relaxation and vitamin B6 on pre-menstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 25 to 18 years; Normal menstruation (bleeding interval: 3 to 8 days and during cycle: 26 to 31 days); Single; no history of mental illness and depression; No history of use antidepressants and hormones drug; Did not have any event in past two months
Age
From 18 years old to 25 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
250
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, subjects were assigned randomly to one of three groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Nursing faculty, Jomhori street, Rafsanjan, Iran
City
Rafsanjan
Postal code
7718796755
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
938
Health conditions studied
1
Description of health condition studied
Premenstrual Syndrome
ICD-10 code
N.94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Premenstrual Syndrome Symptoms
Timepoint
Before the intervention and 3 months after intervention with monthly
Method of measurement
DSM-IV Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group (Relaxation trainee group): received relaxation training in two sessions over one month.These techniques were printed and made available to this group to practice every day, a week before their next menstruation
Category
Treatment - Drugs
2
Description
Second Intervention group (vitamin B6 recipients): A week before their menstruation, were asked to take 80 mg tablets of vitamin B6 (Iran Hormone Company) 3 times per week, for one month
Category
Treatment - Drugs
3
Description
The control group: received no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin's Residences
Full name of responsible person
Nahid Hassani
Street address
Nursing faculty, Jomhori street, Rafsanjan, Iran
City
Rafsanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Street address
Nursing faculty, Jomhori street, Rafsanjan, Iran
City
rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Rafsanjan 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
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Majid Kazemi
Position
Dr
Other areas of specialty/work
Street address
Nursing faculty, Jomhori street, Rafsanjan, Iran
City
Rafsanjan
Postal code
7718796755
Phone
+98 39 1522 5900
Fax
+98 39 1522 8497
Email
maj_kaz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Majid Kazemi
Position
Dr
Other areas of specialty/work
Street address
Nursing faculty, Jomhori street, Rafsanjan, Iran
City
Rafsanjan
Postal code
7718796755
Phone
+98 39 1522 5900
Fax
+98 39 1522 8497
Email
maj_kaz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Nahid Hassani
Position
Licence
Other areas of specialty/work
Street address
Nursing faculty, Jomhori street, Rafsanjan, Iran
City
Rafsanjan
Postal code
7718796755
Phone
+98 39 1522 5900
Fax
+98 39 1522 8497
Email
maj_kaz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)