Role of relaxation and meditation in dysmenorrhea
- Conditions
- Primary dysmenorrhea. Ayurveda Condition: Kashtartava, (2) ICD-10 Condition: N944||Primary dysmenorrhea. Ayurveda Condition: VATAJA-ARTAVADUSHTIH,
- Registration Number
- CTRI/2022/07/044332
- Lead Sponsor
- National Institute Of Ayurveda Pharmacy Department
- Brief Summary
NEED OF STUDY:
Dysmenorrhea is commonest gynaecologicaldisorder. The prevalence of dysmenorrhea is varying from 45% to 95% and primarydysmenorrhea is about 40-50% in reproductive age group. Nearly 40% regularlyused medication and 8-15% stayed absent from work or school. Prevalence is highin adolescents about to 90%.It affects the quality of life in daily routinevery significantly. Haphazard life style pattern, stress and unhealthy foodhabits have positive correlation with dysmenorrhea. All these are parts ofmodern life style, so incidence and prevalence is rising day by day. Painbearing capacity varies from person to person but moderate and severecategories of dysmenorrhea need medication. So females generally prefer NSAIDsfor pain management. These drugs do not correct the morbid reproductivephysiology but subside the pain locally. Another aspect is that these drugshave their own side effects on long term use.
Yoga provides a better approach for themanagement of dysmenorrhea. It corrects root cause and makes the person tohandle the condition by improving mental attitude. It reduces the painsensation by progressive muscle relaxation. It also improves the mentalattitude by improving sattva level and reduces stress level. Most of the womenprefer non pharmacological remedies for their menstrual pain and discomfort.Yoga definitely will be helpful in this condition at physical, mental andemotional levels.
According to Acharya Charak satvavajayaand 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 willbe definitely useful in this condition.
Aim of the study
To evaluate the effect of relaxation and meditation in primarydysmenorrhea.
Objectives of the study:
Primary: Effect of yogic relaxation and meditation on pain inprimary dysmenorrhea.
Secondary:
1. Prevalenceof primary dysmenorrhea in sample population.
2. Evaluationof yogic relaxation and meditation techniques on associated symptoms in primarydysmenorrhea.
Research Question:
Does yogic relaxation and meditation play any role in the management ofprimary dysmenorrhea?
Null hypothesis:
Yogic relaxation and meditation do not have any effect in the managementof primary dysmenorrhea.
MATERIALS AND METHODS
Literature study: All theclassical and contemporary available literature will be searched and criticallyevaluated. The source of literature will be printed and online both.
Study setting: Department ofSwasthavritta and Yoga, Department of prasuti tantra and stri roga, Nationalinstitute of Ayurveda, Jaipur
Total duration of trial: 18 months
Recruitment Period: 12months
Treatment Period: 2 month
Follow up: Every month duringintervention and one month after completion of trial
Type of study: Intervention
Research design:
· Type:Open Randomized Controlled clinical trial.
· Methodof randomization: By generating random number sequence using related software
· Allocationconcealment method: SNOSE
· Numberof Groups: 2
· Typeof Groups: One controlled group and one test group.
Source of Data (Population ofinterest): Patients with primary dysmenorrhea fulfilling the inclusioncriteria.
Sample size: 60 patients will beregistered and they will be divided into group A and group B. Each group willhave 30 patients.
Sampling technique: Nonprobability method as sample frame is not available.
Inclusion criteria:
• Patientswith chief complaint of pain during menstruation for two consecutive cycles.
• Patientswilling for the trial and who will give consent.
• Patientsof age group between 14 to 30 years.
• Grade2 and 3 according to verbal multidimensional scoring system for dysmenorrhea(VMSS)
Exclusion criteria:
• Anymedical or gynaecological history
Discontinuation Criteria:
• Anymajor illness requiring any intervention.
• Therapycompliance less than 80 percent.
• Persondoes not want to continue trial.
• Personsnot following the instructions.
• Facingany complication during trial.
Dropouts: The reason for drop outswill be recorded and will be mentioned in dissertation.
Details of intervention:
Group A (Control): 5 gm *Ashwagandha churna* will be given BD withlukewarm water before meals for 2 month.
Group B (Test): This group will besupervised 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 practiceat home or the regular classes at NIA yoga hall. Yoga at home preferencepatients will be taken care of telephonically. Details of practice are asbelow:
Nadishodhan - 3-5 rounds which may be extended up to 10rounds
Yoganidra - 10-15 minutes
Meditation - 15-20 minutes
Patients will also be advised to take satvik food for total duration ofthe study.
Any illness duringtrial: Participants will be advised to take medicine from relatedconsultant.
Ethical aspects: Detailedinformation will be given to participants about therapy. Informed consent formwill be given and kept for record. Privacy of the participant’s informationwill be maintained.
OUTCOME MEASURE:
Primary outcome: Changesin menstrual distress questionnaire
Secondary outcome: Changes in theother associated symptoms in primary dysmenorrhea.
Assessment criteria: menstrualdistress questionnaire
Data will be recorded twice before andafter the intervention.
Statistical Software to be used: Graphpad
Statistical test to be used: asrequired
Statistical analysis: at 95%confidence interval, 5% Type I error and 80% power of the study
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 60
- 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).
Any medical or gynecological history.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in menstrual distress questionnaire 2months
- Secondary Outcome Measures
Name Time Method Changes in the associated symptoms in primary dysmenorrhea viz nausea, vomiting, fatigue, headache, fainting, sweat, diarrhoea, constipation, vaginal discharge, breast tenderness and giddiness 2months
Trial Locations
- Locations (1)
National Institute of Ayurveda hospital
🇮🇳Jaipur, RAJASTHAN, India
National Institute of Ayurveda hospital🇮🇳Jaipur, RAJASTHAN, IndiaDr Samidha SharmaPrincipal investigator9896336779amodrsamidha@gmail.com