1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [sherylannie6@gmail.com].
   


6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Dysmenorrhea refers to painful menstruation and is classified into primary PD and secondary forms. Primary dysmenorrhea occurs without underlying pelvic pathology and is common in adolescents, manifesting as lower abdominal pain and associated symptoms like nausea, fatigue, and leg pain. It significantly affects daily activities, and its prevalence in India ranges from 50 to 87.8 percent. Secondary dysmenorrhea is linked to pelvic conditions like fibroids or endometriosis and often affects married women.

PD involves hormonal imbalances estradiol and progesterone, leading to elevated prostaglandin levels, which cause uterine muscle contraction, ischemia, and pain. Treatment options include pharmacological methods, like NSAIDs, but these have side effects, prompting interest in non-pharmacological treatments, such as acupuncture.

Acupuncture, particularly Electro-Acupuncture EA, is an effective side-effect-free alternative that can manage chronic pelvic pain and is endorsed by the National Institute of Health. EA involves stimulating acupuncture needles with electrical current to enhance autonomic nervous system activity and reduce pain. The Dai Mai meridian, a key acupuncture point associated with the liver, kidney, and spleen, plays a significant role in regulating pelvic pain, especially in PD cases.

The aim of the study is to assess the impact of Electro-Acupuncture at Dai Mai Meridian on pain severity in primary dysmenorrhea. The primary objective is to evaluate the role of EA on pain, using the Wong-Baker FACES pain scale, and the secondary objective is to assess its effect on heart rate variability HRV in women with PD.

Research Questions

Can Electro-Acupuncture at Dai Mai Meridian influence pain in Primary Dysmenorrhea

Hypothesis

Null Hypothesis: EA at Dai Mai Meridian may not significantly affect pain in PD. Alternate Hypothesis: EA at Dai Mai Meridian may impact pain in PD.

Materials and Methods

Study Design A randomized controlled trial with two groups: intervention n=30 and control n=30. The intervention group will receive electro-acupuncture on Dai Mai meridian points LIV13, GB26, GB27, GB28 using four needles 1-1.5 cun, depth 16-30 mm and electrical stimulation SDZ-V model with a 100 Hz frequency for 20 minutes. Intensity will be adjusted based on patient feedback. Sessions will be conducted twice weekly except during menstruation, totaling 18 sessions over 3 months. The control group will receive no intervention. Baseline and post-assessments will occur on Day 1 and Day 90, respectively.

Participants

Sample Size: 60 Study group: 30 Control group: 30 Sampling Technique: Convenience sampling Source: OPD and IPD of International Institute of Yoga and Naturopathy Medical Sciences College and Hospital, Chengalpattu Inclusion Criteria

Females aged 18-30 years History of primary dysmenorrhea for at least 6 consecutive cycles Moderate to severe dysmenorrhea impacting daily activities Willingness for electrical acupuncture intervention Exclusion Criteria

Conditions like immunodeficiency, malignancy, neurological diseases, or irregular cycles Pregnant lactating women, or those on contraceptives medications for dysmenorrhea in the last 6 months Other medical conditions e.g., cardiovascular diseases, diabetes Fear or unwillingness toward acupuncture Ethical Considerations IEC approval will be obtained. Participants will provide informed written consent.

Randomization and Blinding Participants will be randomized 1:1 ratio using a lottery method with allocation concealment via SNOSE. Subjects will not be blinded to interventions.

Screening Procedures Eligible participants will be screened based on inclusion exclusion criteria. After providing consent, the study will be conducted over 3 months with outcomes assessed using the Wong-Baker FACES Pain Rating Scale WBFS and Heart Rate Variability HRV.

Intervention Electro-acupuncture on the Dai-Mai Meridian LIV13, GB26, GB27, GB28 for 18 sessions over 3 months. Needles inserted unilaterally, stimulated for 20 minutes per session in supine position.

Control Group No intervention.

Primary Outcome

Wong-Baker FACES Pain Rating Scale WBFS: Assesses pain intensity using facial expressions and numerical scores 0-10. Secondary Outcome

Heart Rate Variability HRV: Evaluates autonomic nervous system balance and its impact on pain-related stress. Data Analysis Statistical analysis will be performed using SPSS v16.