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CTRI Number  CTRI/2024/10/074664 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of ear Acupuncture for participants with exam anxiety 
Scientific Title of Study   Effectiveness of Auriculotherapy for exam anxiety among Naturopathy Medical students. A Randomized Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M R Monicaasun 
Designation  PG Scholar, MD(AEM) 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  PG Classroom 3, First floor, Faculty Block, International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, Tamil Nadu, India

Kancheepuram
TAMIL NADU
603001
India 
Phone  9842697489  
Fax    
Email  drmonicaasun27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr N Prabu 
Designation  HOD, Department of Physiology 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  Department of Physiology, Ground Floor, Faculty Block, International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, Tamil Nadu, India

Kancheepuram
TAMIL NADU
603001
India 
Phone  9566351891  
Fax    
Email  drprabubnys91@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr N Prabu 
Designation  HOD, Department of Physiology 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  Department of Physiology, Ground Floor, Faculty Block, International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, Tamil Nadu, India

Kancheepuram
TAMIL NADU
603001
India 
Phone  9566351891  
Fax    
Email  drprabubnys91@gmail.com  
 
Source of Monetary or Material Support  
Dr.M.R.Monicaasun, PG classroom 3, Faculty Block, International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, Tamil Nadu, India, 603001 
 
Primary Sponsor  
Name  Dr M R Monicaasun 
Address  PG Classroom 3, First Floor, Faculty Block, International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, TamilNadu, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M R Monicaasun  International Institute of Yoga and Naturopathy Medical Sciences,  Room No 3, Department of Acupuncture and Energy Medicine, Ground Floor, Faculty block, Kamarajar Nagar, Chengalpattu,
Kancheepuram
TAMIL NADU 
9842697489

drmonicaasun27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  students with exam anxiety 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Auriculotherapy  The PCS PINPAI, Acupuncture Ear Needle, size 0.22 ×1.5mm, will be inserted at Shenmen and Point Zero on bilateral ears a day before the university exam, the needles will be retained in situ for 10 days  
Comparator Agent  Control   Control group participants will be observed without giving any intervention.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  20.00 Year(s)
Gender  Both 
Details  1) Age group: 18- 20 years
2) first year Undergraduate Naturopathy medical students
3) Without alcohol abuse or use of opioid or psychotropic medication within 24 hours prior and during the study
4) Students who are willing to give their consent.
 
 
ExclusionCriteria 
Details  1) Open wounds, burns or scalds in the ears.
2) Who had alcohol or psychotropic medication within 24 hours prior to the study,
3) Auricular infection and inflammation in the ear
4) Who have needle phobia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The Hamilton Anxiety Rating Scale will be used to measure the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), in the total score of less than 17 indicates mild, 18-24 moderate, 25-30 moderate to severe.  one day before exam and on completion of all the exams (after ten days) 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of sleep will be assessed using Pittsburgh Sleep Quality Index (PSQI). It consists of 19 self-reported questionnaires belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction   one day before exam and on completion of all the exams (after ten days) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="10" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  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
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  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 (Others) -  online access

  6. For how long will this data be available start date provided 10-10-2024 and end date provided 03-01-2025?
    Response - Immediately following publication. No end date.

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

Anxiety is an emotion characterized by feelings of tension, worries, and negative physiological reactions.(1) In educational settings, Students learning and understandings are assessed through Examination. This situation drives them into psychological disturbance leading to anxiety. (2)Exam or test anxiety is a stress response experienced before, during and sometimes after exams. If it becomes intense, that can impede academic performances. In comparing with other professional courses medical students reported higher prevalence of anxiety and depression. The vast materials of academic and clinical information to memorize, in a short period of time contributes their psychological state affecting the physical conditions, sleep pattern impairing the motivation, concentration, learning, and performance in the tests.(2,3) Although some levels of anxiety are necessary for academic success, tremendous anxiety such as overwhelming emotions, stressful thoughts, and increasing study load was negatively correlated to hinder the ability of students to understand, manage academic load and the ability to prepare for the examinations.(3)The Hamilton Anxiety Rating Scale identifies students with anxiety impairment.(4,5) It is reliable and valid for educational institutes and exam-anxiety evaluations of the students’ performance.

Acupuncture is a Chinese medical treatment involving in insertion of fine metal needles into the skin and underlying tissues at precise points on the body(6). Auriculotherapy is a branch of acupuncture, performing stimulation of specific points on external ear. Auriculotherapy will be conducted based on STRICTA guidelines.(7) Auriculotherapy is a less invasive method of stimulation of auricular branch of vagus nerve and trigeminal nerve (8)(9). Stimulation of specific points on external ear sends signals to central nervous system through the cranial/spinal nerves, inhibiting inappropriate reflexes and modulates the physiological response by increasing the neurotransmitters (norepinephrine and serotonin) release.(10) The vagus nerve regulates anxiety and anxiety perception areas such as thalamus, brainstem, insula, and, amygdala. Vagus nerve has parasympathetic control, visceral function and it involves in emotional expression, social communication, self-soothing behaviours, regulation of mood, anxiety, pain, hormone regulation.(7)

Previous studies observed that various measures like aromatherapy, relaxation, acupressure(11), and acupuncture are effectively used in managing the exam anxiety. This study aimed to measure anxiety levels and manage the student’s anxiety by activating the parasympathetic nervous system and downregulating the adrenergic activities through Shenmen and Zero point of auriculotherapy.

 
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