Protocol summary
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Study aim
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Determination of effect of ariculotherapy and mefenamic acid on the severity of primary dysmenorrhea and associated with it
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Design
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Randomized clinical trial with control group
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Settings and conduct
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This study is a clinical trial study on 90 students of Qom University of Medical Sciences. In recall of students who have criteria for entering the study, they are continuously enrolled in the study. They were recruited by quadruple blocking method in two groups is randomly assigned. A demographic questionnaire and menstrual status are completed first by all samples. Individuals in both groups are initially examined in a basic cycle and are not involved in this intervention cycle, and only all individuals complete the course registration form. Then interventions are performed in two groups in two menstrual cycles, and the form for recording the course information, including menstruation, verbal multi-dimensional scoring system, and pain ruler, is completed.
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Participants/Inclusion and exclusion criteria
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Single, Iranian, 18-35 years old, Dysmenorrhea with degrees 2- 3 according to verbal multi-dimensional criteria, absence of chronic disease , non-use of pill prevention and weight loss, lack of exercise history,lack of body mass over 30, no smoking, earlessness in ariculotherapy, lack of history of ariculotherapy.
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Intervention groups
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In auriculotherapy group, intervention is done once a week in 2 cycles of menstruation. At the end of the closing session, the menstrual period is placed seeds at 4 points, and squeezing the seeds 4-6 times a day initially begins the onset of menstrual pain. In the mefenamic acid group, taking the 250 mg capsule first takes 2 capsules for the first menstrual symptom, followed by a capsule every 6 hours, and continues until pain is reduced.
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Main outcome variables
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Severity of primary dysmenorrhea and general symptoms associated with it
General information
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Reason for update
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- Due to the prolonged approval and coding process, start and end date recruitment were changed.
-The random allocation to each group performed using a four-block size, which explained previously in the section Randomization description. But in protocol abstract, there is a double block, a typographical error that was changed to four-block size.
- Overall, for people with different menstrual cycles according to the previously mentioned inclusion criteria (menstrual cycle 24-32 days with menstrual length 3-7 days), auriculotherapy is performed between a minimum of 2-3 and a maximum of 3-4 sessions per cycle. during implementation, we noticed that in the relevant section was corrected.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181207041873N1
Registration date:
2019-02-24, 1397/12/05
Registration timing:
prospective
Last update:
2020-02-06, 1398/11/17
Update count:
1
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Registration date
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2019-02-24, 1397/12/05
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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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2019-03-01, 1397/12/10
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Expected recruitment end date
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2019-07-11, 1398/04/20
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Actual recruitment start date
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2019-03-03, 1397/12/12
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Actual recruitment end date
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2019-07-15, 1398/04/24
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Trial completion date
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2019-07-15, 1398/04/24
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Scientific title
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Comprasion of the Effect of Auriculotherapy and Mefenamic Acid on Primary Dysmenorrhea Severity and Systemic Symptoms associated with it in students
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Public title
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Effect of Auriculotherapy a on Primary Dysmenorrhea Severity and Systemic Symptoms associated with it
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Being single
Iranian nationality
Age of 35-18 years
Having regular menstrual periods (length of 3-7 days and the interval between two menstrual periods 32-32 days) in the last two cycles
Having primary dysmenorrhea with rejection of secondary dysmenorrhea with the diagnosis of a specialist
Having menstrual pain as a colic or crampy pain in the suprapubic line, sometimes spreading to the lower back and groin that begins with menstruation and lasts for 2-3 days
Primary dysmenorrhea with degrees 2 and 3 according to verbal multi-dimensional criteria
Experience primary dysmenorrhea in most menstrual cycles
External ear on both sides without lumps, swelling, infection or ulcers in the group of Auriculotherapy
Exclusion criteria:
Lack of any known chronic disease and absence of a pacemaker
No history of anemia, weakness
Non-use of contraceptive pills over the past three months
Failure to lose weight during the study
Not having a regular exercise activity during the 3 months before the start of the study
Lack of body mass index of more than 30 kg per square meter
Not having a history of pelvic inflammatory diseases, endometriosis, myoma, and pelvic tumors with the diagnosis of a doctor
Non-use of tobacco (cigarettes, hookahs and narcotics) and alcohol
No history of any abdominal and pelvic surgery or abnormal ultrasound of the uterus
Non-occurrence of severe psychological stress in the last 6 months, such as parental separation, death of first degree relatives and surgical procedures
Having no history of mood disorders with expert diagnosis
No history of treatment with Auriculotherapy in the last 6 months
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Age
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From 18 years old to 35 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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No information
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Sample size
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Target sample size:
90
Actual sample size reached:
83
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A researcher at a recall in Qom University of Medical Sciences, after his introduction, explains the sufficient information about the research, including the title of research, the goals of the study, the criteria for entering and leaving the study, the manner and manner of conducting the study for students. Individuals who wish to participate in research with primary dysmenorrhea and inclusion criteria are referred to the researcher by telephone for their research, and are included in the continuous sampling method. The research units are then assigned to the two groups of Auricolotherapy and Mefenamic acid by randomization. In a block random method, quadrilateral blocks are created, in which randomly, half of each block is placed in one group and the other half in the other group. In this study, we want to identify 90 people in two groups of 45 patients with Auricolotherapy and Mefenamic acid, first we identify all four-state states in which half of the people are assigned in the Auricolotherapy group and the other half in the Mefenamic acid group. Then, to each of these four-state combinations that include six modes, we assign one of the digits 1-6. Then we select 25 randomly random numbers from 1 to 6, and we write the combinations of it in succession, and the subjects enter into two groups.
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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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2018-09-29, 1397/07/07
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Ethics committee reference number
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IR.IUMS.REC.1397.550
Health conditions studied
1
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Description of health condition studied
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Primary Dysmenorrhea and Systemic Symptoms associated with it
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Severity of primary dysmenorrhea
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Timepoint
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Measurement in three cycles of menstruation including basal cycle, first and second cycle of menstruation in intervention
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Method of measurement
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Visual Analogue Scale
2
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Description
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General symptoms associated with dysmenorrhea
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Timepoint
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Measurement in three cycles of menstruation including basal cycle, first and second cycle of menstruation in intervention
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Method of measurement
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Verbal Multidimensional Scoring system
Intervention groups
1
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Description
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Intervention group: In the auriculotherapy group, it was explained to each person that auriculotherapy is started once every 6 days for 2 cycles of menstruation for each person, and the intervention begins at the end of a menstrual period and continues until the end of the menstrual period. . Totally, for women with different menstrual cycles, the ariculotherapy was performed from at least 2-3 to a maximum of 3 to 4 sessions per cycle each intervention cycle. This practice was carried out by a trained researcher with a degree in auriculotherapy, in a private environment that was designed for this purpose. At the last session of near-menstrual at 4 drops, both ears of herbs were inserted into the ear and explained to people that initiating the onset of the syndrome initially began the onset of menstrual pain, and each point for 1 minute 6 to 4 times a day Press at intervals of at least 1 hour and continue pressing the dots until the end of the menstrual period, and then remove the acne from the pain for 24 hours after relieving pain. Seed in place could stay for 7 days. To avoid forgetting, squeezing the syndas was reminded by telephone and through the virtual group. The strength of the seizures should be such as to cause pain and burning in the outer ear. They were also informed that various feelings might be felt by the pressure of the blood vessels, such as numbness, swelling, mild pain, or heat. People were told that the cheeks were not easily removed and their adhesives relative to body oil They do not react and can not be easily removed from the ear. In the case of going to the bath, the ears should only be washed with water, and until the drying of the ears, do not touch the syringes and inform the researcher if Seyed is detached. To remove the worms, it is best for the patient to put his ears down (ground) The 11 points used to relieve dysmenorrhea were used: the main points of my gravel, thalamic, ziro point and endocrine point, and the anatomical points of the uterus, genitals, ovaries, and the supporting regions of the kidneys, pelvis, vagus, and The prostaglandin is the point. Electric stimulation of the ear after ear disinfection with 70% alcohol and 1 minute of general massage of the ear for relaxation, through the skin at points with a 2-point pointer machine, with a frequency of 2 Hz and a current of 4-2 mA for 20 seconds. Each point was applied by the researcher. At the end of the closing session, the next menstrual period was placed at 4 points in my gravel, thalamic, uterus, and pelvic seated.
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Category
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Treatment - Other
2
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Description
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Control group: In the mefenamic acid group, people were told to use a 250 mg mefenamic acid capsule during the two menstrual cycles to make the Amin Pharmaceuticals company with the first symptom of menstrual start, such as cramp, pain or bleeding. How to use it was that the first time 2 capsules and then every 6 hours to take a capsule and continue until pain relief. The study units were told to follow this intervention for both menstruation cycles.
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Category
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Treatment - Drugs
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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Iran 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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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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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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Yes - There is 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
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Title and more details about the data/document
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Only part of the information, such as information on the main outcome or the like, can be shared
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When the data will become available and for how long
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Start the access period 6 months after publishing the results
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To whom data/document is available
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Data for researchers and people who are engaged in treatment can apply for them
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Under which criteria data/document could be used
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Data for researchers and people who are engaged in treatment can apply for them
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From where data/document is obtainable
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by Email
m.vahedi_89@yahoo.com
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What processes are involved for a request to access data/document
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by Email
m.vahedi_89@yahoo.com
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Comments
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6 months after publishing the results