Protocol summary
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Study aim
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Determining the effect of vitamin D3 and positive group counseling on lifestyle changes in premenstrual women of reproductive age
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Design
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A parallel clinical trial with a parallel control group, randomized
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Settings and conduct
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Random sampling is performed on women of reproductive age in Arsanjan for all groups of premenstrual syndrome before the study, at 6 weeks and 10 weeks after the intervention. Satisfaction with intervention methods is complete in 6 and 10 weeks.
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Participants/Inclusion and exclusion criteria
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Criteria for the study included participants' self-report of no history of treatment or lack of contraceptive pills, any herbal remedies, or pre-menopausal, drug-treated; having two menstrual cycle after a year.
Criteria for exit are: stressful events, such as the death of relatives, parental separation, accidents, failure to attend two or more meetings.
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Intervention groups
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In the intervention group with positive group-based method, 6 group sessions are held once a week for 90 minutes in online counseling sessions because of covid 19 pandemic .
Intervention group consuming vitamin D3, met criteria and after determining 25-hydroxy vitamin D level, subjects with serum levels less than 30 ng / ml will be enrolled. Each person is given 6 doses of vitamin D3, 50,000 units to be taken 1 doses per week for 6 weeks. D is given 50,000 units and re-measured at the end of the intervention
For lifestyle change groups, sessions on appropriate physical activity, weight and fitness control, healthy eating, menstrual health, tobacco harm and familiarity with early detection methods of common female cancer (breast and cervical cancer) and during 6 The meeting will be held in 6 online sessions.
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Main outcome variables
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1-Premenstural syndrome, 2- Satisfaction with intervention methods
General information
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Reason for update
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1- Registration of the end of the trial, 2- Correction of the intervention, which was registered in combination of three face-to-face sessions three online sessions, but because of covid 19 pandemic all 6 sessions in 3 groups were held online.
3- As you can see in intervention in intervention section and other parts of trial PMS and satisfaction with intervention methods were mentioned as main outcome variables but in main outcome variables box only study applicable aim was mentioned, so main outcome variables should be corrected.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191231045967N1
Registration date:
2020-02-11, 1398/11/22
Registration timing:
prospective
Last update:
2021-06-15, 1400/03/25
Update count:
1
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Registration date
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2020-02-11, 1398/11/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-02-20, 1398/12/01
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Expected recruitment end date
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2020-04-02, 1399/01/14
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Survey the effect of vitamin D3 tablet intake, positivism group consulting with changing in life style in the treatment of premenstrual syndrome in women
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Public title
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Determining the effect of vitamin D3 and positive group counseling with lifestyle changes in premenstrual women of reproductive age
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Being a resident of Rafsanjan city
No history of treatment or depression or anxiety disorder
No history of treatment or eating disorder
No history of treatment or anemia disorder
No history of treatment or thyroid disorder
No history of treatment or presence of diabetes
Not taking birth control pills for medical reasons
Not taking any herbal medicine or medicine that affects premenstrual syndrome
Lack of treatment with psychiatric drugs and other non-pharmacological methods
Lack of treatment with other non-medicinal methods
Having two consecutive menstrual cycles a year with symptoms of premenstrual syndrome with at least five symptoms, one of which are mood disorders, which begin in the second half of the menstrual cycle and improve after menstruation, according to the self-report.
Having at least a 30% increase in symptom severity within 5 days before menstruation based on the PMS
Willingness to continue collaborating on tasks for 6 weeks
Failure to participate in another related study until the expiration of the current study
Exclusion criteria:
Severe form of premenstrual syndrome with a score of 35 and more from the premenstrual syndrome calendar
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Age
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From 20 years old to 40 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
84
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple random sampling
In this way, we first obtain the list of all members, then assign a score to each of them, and select the required number using the random number table.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-12-31, 1398/10/10
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Ethics committee reference number
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IR.SSU.REC.1398.157
Health conditions studied
1
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Description of health condition studied
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Women's premenstrual syndrome
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ICD-10 code
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N94.3
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ICD-10 code description
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Premenstrual tension syndrome
Primary outcomes
1
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Description
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1-Mean premenstrual syndrome scores, 2- Satisfaction with intervention methods
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Timepoint
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1-ّFor premenstrual syndrome before the intervention, complete the sixth week of the intervention and finish the tenth week.2- At the end of 6 and 10 weeks
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Method of measurement
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1-Premenstrual Syndrome Screening Tool , 2-Satisfaction tool
Intervention groups
1
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Description
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Intervention group: Intervention group consuming vitamin D3, with a criterion and after determining 25 hydroxyvitamin D level, subjects with serum level less than 30 ng / ml will be included in the study. Each person is given 6 capsules of vitamin D 50000, D3 to take 1 dose per week for 6 weeks. After 6 weeks of administration and determination of 25-جhydroxytryptamine serum level, the physician is instructed to take one vitamin D within 4 weeks. 50,000 units manufactured by the pharmaceutical company are disposed of and re-measured at the end of the intervention. The premenstrual syndrome form is completed before the study, at 6 weeks and 10 weeks after the intervention. Satisfaction with intervention methods is assessed in weeks 6 and 10.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: In the intervention group, 6 group sessions will be held online because of covid 19 pandemic once a week for 90 minutes in a positive-group group. After selecting the women for the meetings, we select the days of the two groups' meetings as suggested by the women on two different days of the week so that the two groups receiving the consultation do not interact with each other. , Second session, gratitude meeting, third session, constructive active response, fourth session, counting blessings, fifth session, sense of taste, sixth session, preservation of therapeutic effects. Pre-menstrual syndrome form before study, 6 weeks intervention and Week 10 was completed after the intervention. Satisfaction with intervention method is assessed in weeks 6 and 10.
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Category
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Behavior
3
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Description
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Control group: Lifestyle group sessions on appropriate physical activity, weight and fitness control, healthy eating, menstrual mental health, tobacco harm and familiarity with early detection methods of common female cancer (breast and cervical cancer) and during 6 sssions for 2 groups are held in two days, 6 sessions online because of covid 19 pandemic. The premenstrual syndrome form is completed before the study, at 6 weeks and 10 weeks after the intervention. Satisfaction with intervention method is assessed in weeks 6 and 10.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available