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IRCT20190318043086N1 IRCT 2019-06-14 Babol University of Medical Sciences The Effect of Rosa Foetida Extract with Self-care behavior Education on Primary Dysmenorrhea ندارد The Effect of Rosa Foetida Extract with Self-care behavior Education on Primary Dysmenorrhea in Female Students of Babol University of Medical Sciences 2019-05-22 anticipated 135 Complete https://irct.ir/trial/38551 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: does not have, Randomization description: The subjects are assigned to three groups by random blocking and , Students are homogeneous according to body mass index, age of first menstruation and education, and mean score of severity of menstrual pain before treatment and educational actions, Blinding description: Study will be single blind. according to the coding the medicine packs the Participants who receiving will not be aware of the type of the medicine.,. 2 Menstrual pain or Primary Dysmenorrhea. Intervention 1: Intervention group: Self-care behavior Education.This group will take dysmenorrhea self-care behaviors classes as two-days training sessions, the first and second part of the educational content in one day, and the third and fourth sections on the second day (60 to 90 minutes each day) as lectures and group discussion, practical demonstration. The content of the classes includes: - Anatomy and genital physiology education - Healthy nutrition during menstruation - Isometric exercises - Tips during menstruation - Relaxation techniques (relaxation and musical therapy and breathing) and heat and message therapy. We will ask the students in the group which got dysmenorrhea self care education only as intervention, that define their intensity of menstrual pain by visual analogue scale,1, 2, 4, 8, 12,24 hours after the start of their menstruation in two consecutive menstrual cycles in the first two days of each cycle, and also complete the measure of menstrual distress and the scale of self-care behaviors in dysmenorrhea at the end of the second day. Intervention 2: Control group:Self-care education along placebo. In the training group along placebo in addition to dysmenorrhea self-care education, 200 mg of placebo capsules will be given every 8 hours in the first two days of the cycle for two consecutive cycles, and the intensity of pain will be defined on the visual analog scale.1, 2, 4, 8, 12, 24, 48 hours after the start of treatment. The menstrual distress scale and the dysmenorrhea scale of self-care behaviors in at the end of the second day. Intervention 3: Intervention group: Dysmenorrhea Self-care education along Rosa foetida extract capsule.Capsules of Rosa foetida extract will be prepared in Pharmacology Laboratory of Babol Medical School.In the training group along Rosa foetida extract in addition to dysmenorrhea self-care education, 200 mg of the extract capsules will be given every 8 hours in the first two days of the cycle for two consecutive cycles, and the intensity of pain will be defined on the visual analog scale.1, 2, 4, 8, 12, 24, 48 hours after the start of treatment. The menstrual distress scale and the dysmenorrhea scale of self-care behaviors in at the end of the second day.Medications will be prepared in the form of placebo capsules and Rosa-foetida extract capsules. They will get coded in the same envelopes, along with the prescription for taking the medicine. Pharmaceutical will be prepared with the help of a medicinal plants specialist in Babol University of Medical Sciences. The medicine will be prepared in the laboratory under relevant rules. To do this, the fruit of Rosa foetida will get dried then by milling to powder and then extracted with 70% ethanol by massaging, then the extract is dispersed using a rotary evaporator under low pressure solvent .The obtained extract will be kept in a freezer in- 21 ° C for the preparation of capsules. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Hajar Pasha
Ganj Afrouz Avenue, Babol University of Medical Sciences, Mazandaran Province
babol Iran (Islamic Republic of) 47176-47754 +98 11 3219 7667 dhajarpasha@gmail.com Babol University of Medical Sciences scientific Shabnam Omidvar
Department of Midwifery, Babol University of medical sciences, Ganj afrooz Street, Babol- Iran
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 9592 sh.omidvar@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Single girls have clinical symptoms of primary dysmenorrhea with pain score (5 or more) based on visual analog scale Clinical symptoms of dysmenorrhea in at least 3 of 6 previous menstrual periods. being single Age of 18 to 24 years Signing Consent Form Body mass index between 19 - 30 Regular cycles with duration of 21- 35 days Length of bleeding 3- 7 days Not having any menstrual cycle disorder during the 3 months before the study Non-steroidal anti-inflammatory and anti-progestin at least a week before start of the period. Non-use of hormonal drugs and oral contraceptives Lack of special diet during the past 3 months The desire to participate in the study 18 years 24 years Female Pain score less than 5 based on visual analog scale History of genitourinary disease or history of abdominal and pelvic surgery History of blood diseases stomach ache Disorders of the kidney function Stressful accidents over the past six months Discontinue drug use History of allergic diseases History of allergy to medicinal herbs History of allergy with non-steroidal anti-inflammatory drugs Taking supplements and vitamins Unwilling to continue study incomplete questionnaire Probable event of complications History of a prominent physical and psychological problem. N94.4 Primary dysmenorrhea Lifestyle Placebo Treatment - Other Intervention group: Self-care behavior Education.This group will take dysmenorrhea self-care behaviors classes as two-days training sessions, the first and second part of the educational content in one day, and the third and fourth sections on the second day (60 to 90 minutes each day) as lectures and group discussion, practical demonstration. The content of the classes includes: - Anatomy and genital physiology education - Healthy nutrition during menstruation - Isometric exercises - Tips during menstruation - Relaxation techniques (relaxation and musical therapy and breathing) and heat and message therapy. We will ask the students in the group which got dysmenorrhea self care education only as intervention, that define their intensity of menstrual pain by visual analogue scale,1, 2, 4, 8, 12,24 hours after the start of their menstruation in two consecutive menstrual cycles in the first two days of each cycle, and also complete the measure of menstrual distress and the scale of self-care behaviors in dysmenorrhea at the end of the second day. Control group:Self-care education along placebo. In the training group along placebo in addition to dysmenorrhea self-care education, 200 mg of placebo capsules will be given every 8 hours in the first two days of the cycle for two consecutive cycles, and the intensity of pain will be defined on the visual analog scale.1, 2, 4, 8, 12, 24, 48 hours after the start of treatment. The menstrual distress scale and the dysmenorrhea scale of self-care behaviors in at the end of the second day. Intervention group: Dysmenorrhea Self-care education along Rosa foetida extract capsule.Capsules of Rosa foetida extract will be prepared in Pharmacology Laboratory of Babol Medical School.In the training group along Rosa foetida extract in addition to dysmenorrhea self-care education, 200 mg of the extract capsules will be given every 8 hours in the first two days of the cycle for two consecutive cycles, and the intensity of pain will be defined on the visual analog scale.1, 2, 4, 8, 12, 24, 48 hours after the start of treatment. The menstrual distress scale and the dysmenorrhea scale of self-care behaviors in at the end of the second day.Medications will be prepared in the form of placebo capsules and Rosa-foetida extract capsules. They will get coded in the same envelopes, along with the prescription for taking the medicine. Pharmaceutical will be prepared with the help of a medicinal plants specialist in Babol University of Medical Sciences. The medicine will be prepared in the laboratory under relevant rules. To do this, the fruit of Rosa foetida will get dried then by milling to powder and then extracted with 70% ethanol by massaging, then the extract is dispersed using a rotary evaporator under low pressure solvent .The obtained extract will be kept in a freezer in- 21 ° C for the preparation of capsules. Intensity of pain. Timepoint: 1،2، 4، 8، 12، 24، 48 The hour after the onset of menstrual pain. Method of measurement: Visual Analogue Scale. Menstrual distress score. Timepoint: One month before the intervention During the first two days of menstruation and in two Consecutive cycles. Method of measurement: Menstrual distress scales. Menstrual bleeding severity. Timepoint: One month before the intervention in two Consecutive cycles. Method of measurement: Pictorial Schedule Questionnaire. Side effects. Timepoint: During two cycles of taking drug. Method of measurement: Ask the participant. Number of absent days of class. Timepoint: One month before the intervention and two consecutive cycles. Method of measurement: Ask the participant. Babol University of Medical Sciences Approved 2019-01-29 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganj Afroz Street, babol, mazandaran babol Mazandaran Iran (Islamic Republic of)