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 [manikandan.benjamin@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

Anxiety is a complex emotional and physiological response that often impairs individuals’ performance, particularly in young adults in competitive environments. Medical students are disproportionately affected, with a high prevalence in India (66.8%), often linked to academic pressure and workload. While Auriculo-acupuncture (AA) has shown promise in modulating the autonomic nervous system and reducing anxiety, its impact on situational anxiety through heart rate variability (HRV) and the State-Trait Anxiety Inventory (STAI) needs further investigation.

Aim and Objectives

• Aim: To evaluate the effects of Auriculo-acupuncture on situational anxiety and cardiac autonomic function.
• Primary Objective: Assess the impact of Auriculo-acupuncture on HRV parameters.
• Secondary Objective: Evaluate its effect on STAI scores.

Research Design
This randomized controlled study will involve 80 participants (18–30 years) with situational anxiety (STAI score >50). Participants will be divided into study (n=40) and control (n=40) groups.

• Study Group: Receives Auriculo-acupuncture at Point Zero and the adrenal point for 14 consecutive days.
• Control Group: Waitlisted without intervention.

Assessment Tools

• HRV: To measure parasympathetic activity and cardiac autonomic function.
• STAI: To evaluate anxiety levels pre- and post-intervention.

Inclusion and Exclusion Criteria
Eligible participants include males and females aged 18–30 with STAI scores >50. Individuals with chronic illnesses, mental health conditions, needle phobia, or contraindications for ear acupuncture are excluded.

Intervention

• Auriculo-acupuncture Group: Press needles (3x3 mm) will be inserted unilaterally at Point Zero (root of helix) and adrenal point (inferior tragus) for 30 minutes daily.
• Control Group: No intervention during the study period.

Ethical Considerations
The study will be approved by the Institutional Ethics Committee, with informed consent obtained from participants.

Outcome Measures

1. Primary Outcome: Changes in HRV, reflecting parasympathetic activation.
2. Secondary Outcome: Changes in STAI scores, assessing anxiety levels.

Significance
The study aims to provide evidence for using Auriculo-acupuncture as a non-invasive, holistic approach to managing situational anxiety, with a focus on improving cardiac autonomic balance and reducing anxiety symptoms