Impact of Auriculo-Acupuncture on situational anxiety and cardiac autonomic functions - A Randomised controlled trail.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluation of changes in parasympathetic activation using Heart Rate Variability (HRV) before and after the intervention among individuals experiencing situational anxiety. HRV measures the variation in time intervals between consecutive heartbeats and serves as a straightforward yet effective tool for assessing fluctuations in sympathetic and parasympathetic nervous system activity via neurocardiac and heart-brain interactions. It also provides insights into blood pressure (BP), gastrointestinal, cardiac, and vascular tone. The impact of auriculoacupuncture at point zero and the adrenal point on cardiac autonomic functions will be examined through HRV among individuals with situational anxiety. Collected data will be interpreted and analyzed to derive conclusions
研究概览
简要总结
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
- Primary Outcome: Changes in HRV, reflecting parasympathetic activation.
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Both genders
- •Individuals with the age group with 18 to 30 years.
- •Individuals who score above 50 in State Trait Anxiety Inventory.
- •Signing written informed consent.
- •Agreeing to participate in the study and adhere to doctors instructions.
排除标准
- •Individuals experiencing any chronic illness (e.g., CKD, Heart disease)
- •Individuals with a history of significant trauma.
- •Individuals with chronic medical or mental health conditions & Needle phobia.
- •Individuals using any psychotropic medications.
- •Individuals advised by physicians against participating in other therapeutic interventions.
- •Extensive ear rings.
- •Female during menstruation, pregnancy and lactation.
- •Open wounds, burns or scalds in the ears.
结局指标
主要结局
Evaluation of changes in parasympathetic activation using Heart Rate Variability (HRV) before and after the intervention among individuals experiencing situational anxiety. HRV measures the variation in time intervals between consecutive heartbeats and serves as a straightforward yet effective tool for assessing fluctuations in sympathetic and parasympathetic nervous system activity via neurocardiac and heart-brain interactions. It also provides insights into blood pressure (BP), gastrointestinal, cardiac, and vascular tone. The impact of auriculoacupuncture at point zero and the adrenal point on cardiac autonomic functions will be examined through HRV among individuals with situational anxiety. Collected data will be interpreted and analyzed to derive conclusions
时间窗: Baseline, After 14 days
次要结局
- The impact of auriculoacupuncture on Point Zero and the adrenal point among individuals experiencing situational anxiety was assessed using the State Trait Anxiety Inventory (STAI). This scale consists of twenty questions designed to identify individuals with anxiety issues and to guide interventions aimed at reducing anxiety. The items on the scale assess self-reported anxiety symptoms and cognitive factors that may hinder performance in students. Due to its simplicity and brevity, the STAI scale is recommended for screening anxiety-related impairments and guiding intervention strategies. Respondents rate the extent to which each statement applies to them, ranging from "not at all" to "very much so," using a 4-point scale.(Baseline, After 14 Days)
研究者
Dr T Manikandan
International Institute of Yoga and Naturopathy Medical Sciences,