NEED OF STUDY: Dysmenorrhea is commonest gynaecological
disorder. The prevalence of dysmenorrhea is varying from 45% to 95% and primary
dysmenorrhea is about 40-50% in reproductive age group. Nearly 40% regularly
used medication and 8-15% stayed absent from work or school. Prevalence is high
in adolescents about to 90%.It affects the quality of life in daily routine
very significantly. Haphazard life style pattern, stress and unhealthy food
habits have positive correlation with dysmenorrhea. All these are parts of
modern life style, so incidence and prevalence is rising day by day. Pain
bearing capacity varies from person to person but moderate and severe
categories of dysmenorrhea need medication. So females generally prefer NSAIDs
for pain management. These drugs do not correct the morbid reproductive
physiology but subside the pain locally. Another aspect is that these drugs
have their own side effects on long term use. Yoga provides a better approach for the
management of dysmenorrhea. It corrects root cause and makes the person to
handle the condition by improving mental attitude. It reduces the pain
sensation by progressive muscle relaxation. It also improves the mental
attitude by improving sattva level and reduces stress level. Most of the women
prefer non pharmacological remedies for their menstrual pain and discomfort.
Yoga definitely will be helpful in this condition at physical, mental and
emotional levels. According to Acharya Charak satvavajaya
and Samadhi are the key principle for the treatment of manas disorders (Ch.
Su.1).Manas factor play a crucial role in causation of dysmenorrhea, so it will
be definitely useful in this condition. Aim of the study To evaluate the effect of relaxation and meditation in primary
dysmenorrhea. Objectives of the study: Primary: Effect of yogic relaxation and meditation on pain in
primary dysmenorrhea. Secondary: 1. Prevalence
of primary dysmenorrhea in sample population. 2. Evaluation
of yogic relaxation and meditation techniques on associated symptoms in primary
dysmenorrhea. Research Question: Does yogic relaxation and meditation play any role in the management of
primary dysmenorrhea? Null hypothesis: Yogic relaxation and meditation do not have any effect in the management
of primary dysmenorrhea. MATERIALS AND METHODS Literature study: All the
classical and contemporary available literature will be searched and critically
evaluated. The source of literature will be printed and online both. Study setting: Department of
Swasthavritta and Yoga, Department of prasuti tantra and stri roga, National
institute of Ayurveda, Jaipur Total duration of trial: 18 months Recruitment Period: 12
months Treatment Period: 2 month Follow up: Every month during
intervention and one month after completion of trial Type of study: Intervention Research design: · Type:
Open Randomized Controlled clinical trial. · Method
of randomization: By generating random number sequence using related software · Allocation
concealment method: SNOSE · Number
of Groups: 2 · Type
of Groups: One controlled group and one test group. Source of Data (Population of
interest): Patients with primary dysmenorrhea fulfilling the inclusion
criteria. Sample size: 60 patients will be
registered and they will be divided into group A and group B. Each group will
have 30 patients. Sampling technique: Non
probability method as sample frame is not available. Inclusion criteria: • Patients
with chief complaint of pain during menstruation for two consecutive cycles. • Patients
willing for the trial and who will give consent. • Patients
of age group between 14 to 30 years. • Grade
2 and 3 according to verbal multidimensional scoring system for dysmenorrhea
(VMSS) Exclusion criteria: • Any
medical or gynaecological history Discontinuation Criteria: • Any
major illness requiring any intervention. • Therapy
compliance less than 80 percent. • Person
does not want to continue trial. • Persons
not following the instructions. • Facing
any complication during trial. Dropouts: The reason for drop outs
will be recorded and will be mentioned in dissertation. Details of intervention: Group A (Control): 5 gm Ashwagandha churna will be given BD with
lukewarm water before meals for 2 month. Group B (Test): This group will be
supervised yoga practice at morning or evening (empty stomach or before meal)
for two weeks at NIA yoga hall. After that patients will be advised to practice
at home or the regular classes at NIA yoga hall. Yoga at home preference
patients will be taken care of telephonically. Details of practice are as
below: Nadi
shodhan - 3-5 rounds which may be extended up to 10
rounds Yoga
nidra - 10-15 minutes Meditation - 15-
20 minutes Patients will also be advised to take satvik food for total duration of
the study. Any illness during
trial: Participants will be advised to take medicine from related
consultant. Ethical aspects: Detailed
information will be given to participants about therapy. Informed consent form
will be given and kept for record. Privacy of the participant’s information
will be maintained. OUTCOME MEASURE: Primary outcome: Changes
in menstrual distress questionnaire Secondary outcome: Changes in the
other associated symptoms in primary dysmenorrhea. Assessment criteria: menstrual
distress questionnaire Data will be recorded twice before and
after the intervention. Statistical Software to be used: Graph
pad Statistical test to be used: as
required Statistical analysis: at 95%
confidence interval, 5% Type I error and 80% power of the study
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