Protocol summary
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Study aim
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1. The effect of yoga on premenstrual syndrome
2. The effect of yoga on sleep quality in women with premenstrual syndromeyoga on premenstrual syndrome
3.Yoga effect on anxiety in women with premenstrual syndrome
4.Yoga effect on depression and Blood Pressure in women with premenstrual syndrome
5. The effect of yoga on quality of life in women with premenstrual syndrome
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Design
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This is a double-blind, randomized controlled trial. Allotment in the yoga and control group will be done randomly in blocks 4 and 6 with an assignment ratio of 1 to 1. The sample size will be 62, which will be selected in each group of 31
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Settings and conduct
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In this double-blind randomized clinical trial, among women referring
At the private clinics of Tabriz women and delivery, those who were admitted to study with their desire to ask for a PSN PSK screening questionnaire for one month, and asked those who were diagnosed with PSAs with premenstrual syndrome, after obtaining informed consent, 61 Persons selected in a class and randomly assigned 4 and 6 blocked blocks to 31 yoga groups and 31 control group. Yoga moves for 10 weeks and each week in 3 60-minute sessions. Finally, the data on the variables of mood, behavior, physical and pms effects on the life of the questionnaires were analyzed using covariance analysis.
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Participants/Inclusion and exclusion criteria
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1. Women aged 18 to 45
2. Having a regular menstrual period
3.Catching PMS
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Intervention groups
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Yoga exercises are conducted by a yoga instructor for a period of 10 weeks and each week for 3 sessions of 60 minutes.
The samples will be applied and no intervention will be performed for the control group.
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Main outcome variables
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Yoga affects mood, behavior and physical symptoms in women with premenstrual syndrome.
General information
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Reason for update
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Acronym
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PMS
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IRCT registration information
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IRCT registration number:
IRCT201501216582N9
Registration date:
2015-03-15, 1393/12/24
Registration timing:
prospective
Last update:
2019-01-26, 1397/11/06
Update count:
1
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Registration date
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2015-03-15, 1393/12/24
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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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Tabriz university of medical sciences branch aras
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Expected recruitment start date
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2015-03-20, 1393/12/29
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Expected recruitment end date
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2015-04-09, 1394/01/20
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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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The effect of yoga on women’s premenstrual syndrome
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Public title
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The effect of yoga on premenstrual syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion criteria: age range of 20 till 45 years old
Having regular history of menstruation
Suffering from PMS according to the results of PSST questionnaire in two periods before intervention
No consumption of effective medication on premenstrual syndrome and anti-pregnancy drugs three months before entering the study
No history of depression based on the patients’ self representation
No history of diseases related to genital organs based on the patients’ own representation
No consumption of herbal drugs effective for premenstrual syndrome during last three months
No consumption of alcohol, cigars and other impermissible materials based on the patients’ own representation
No history of joints diseases and arthritis based on the patients’ own representation
No history of surgery in body organs preventing individual from doing yoga practices
No athletes; No consumption of caffeine; Tendency to participate in the research
Exclusion criteria:
No tendency to remain in the study
Having a history of yoga practices
Occurrence of any influential incidence to the study trend, occurrence of stressful incidents like the death of close relatives during last 6 months
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Age
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From 20 years old to 45 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Investigator
- Data analyser
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Sample size
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Target sample size:
62
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Allocations in yoga and control groups will be done randomly in blocks 4 and 6 with a 5: 5 assignment ratio. In order to hide the allocation of opaque envelopes, which will be numbered sequentially. These packs are already prepared by the non-involved researcher in the data collection and the first envelope will be given to the first person with the inclusion criteria and will continue to complete the sample volume.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This study was an interventional study of double-blind randomized controlled clinical trial, in which the data collector and analyzer were blind.
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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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no
Ethics committees
1
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Ethics committee
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Approval date
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2015-02-20, 1393/12/01
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Ethics committee reference number
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IRCT201501216582N9
Health conditions studied
1
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Description of health condition studied
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Depression
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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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Symptoms of premenstrual syndrome
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Timepoint
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Before intervention and 10 weeks after intervention
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Method of measurement
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PSST Questionnaire
Secondary outcomes
1
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Description
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The Effect of Yoga on Quality of Sleep of Women with Premenstrual Syndrome
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Timepoint
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Before intervention and 10 weeks after intervention
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Method of measurement
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PSST Questionnaire
2
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Description
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Added at 2016-10-11: quality of sleep
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Timepoint
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Added at 2016-10-11: 2015/4/29 to 2015/7/11
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Method of measurement
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Added at 2016-10-11: Quality of Sleep Questionnaire
3
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Description
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The Effect of Yoga on Depression and Blood Pressure of Women with Premenstrual Syndrome
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Timepoint
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Before intervention and 10 weeks after intervention
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Method of measurement
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Beck Depression Questionnaire
4
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Description
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The Effect of Yoga on Anxiety and Vital Signs of Women with Premenstrual Syndrome
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Timepoint
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Before Intervention and 10 Weeks After Intervention
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Method of measurement
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Hamilton Anxiety Rating Scale
5
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Description
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The Effect of Yoga on Quality of Life of Women with Premenstrual Syndrome
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Timepoint
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Before Intervention and 10 Weeks After Intervention
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Method of measurement
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Quality of Life SF36 Questionnaire
Intervention groups
1
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Description
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The yoga group will exercise the designed movements under supervision of the yoga coach for 10 weeks in three sessions and each session for 60-minute every week.
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Category
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Treatment - Other
2
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Description
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The control group will not receive intervention.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Deputy of Scientific and Research of Nursing and Midwifery Faculty
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Grant code / Reference number
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N/A
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Tabriz University of Medical Sinence
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Proportion provided by this source
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100
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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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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Information on the main outcome
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When the data will become available and for how long
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2016
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To whom data/document is available
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People working in academic institutions
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Under which criteria data/document could be used
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To check the results and the relationship of data
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From where data/document is obtainable
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00989144058245
Ghafoureh ghaffarilaleh
ghafoureh@gmail.com
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What processes are involved for a request to access data/document
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Email or mobile will be sent within two weeks.
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Comments
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I would share my scientific information.