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CTRI Number  CTRI/2024/09/073366 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 22/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Immediate effect of Auriculotherapy on Exam anxiety 
Scientific Title of Study   Immediate effect of Auriculotherapy on 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  MR Monicaasun 
Designation  PG Scholar 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  International Institute of Yoga and Naturopathy Medical Sciences, PG Class Room 3, First floor, Faculty Block,Department of Acupuncture and Energy Medicine,Chengalpattu, Tamilnadu, India.

Kancheepuram
TAMIL NADU
603001
India 
Phone  09842697489  
Fax    
Email  drmonicaasun27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prabu 
Designation  Head of the Department(I/C) 
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, TamilNadu, India

Kancheepuram
TAMIL NADU
603001
India 
Phone  9566351891  
Fax    
Email  drprabubnys91@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prabu 
Designation  Head of the Department(I/C) 
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, TamilNadu, India

Kancheepuram
TAMIL NADU
603001
India 
Phone  9566351891  
Fax    
Email  drprabubnys91@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  MRMonicaasun 
Address  International Institute of Yoga and Naturopathy Medical Sciences, PG Class Room 3, First floor, Faculty Block,Department of Acupuncture and Energy Medicine,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  International Institute of Yoga and Naturopathy Medical Sciences, PG Class Room 3, First floor, Faculty Block,Department of Acupuncture and Energy Medicine,Chengalpattu, Tamilnadu, India.
Kancheepuram
TAMIL NADU 
9842697489

drmonicaasun27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu-603 001.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Students appearing for university examination 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Auriculotherapy  Auriculotherapy will be performed by an experienced doctor in Traditional Chinese Medicine using PCS PINPAI, Acupuncture Ear Needle, size 0.22 ×1.5mm, were inserted at Shenmen and Point Zero on bilateral ears a on the day university examination before 30 minutes, the needles were retained in situ for 3.30 hours and removed after completion of the exam. The needle will be sufficiently inserted to induce “de qi”: a dull ache, numbness, or tingling sensation characteristic to acupuncture. Total duration of the intervention will be last for 3.30 hours. 
Comparator Agent  No intervention  Participants will not receive any intervention during the intended study period  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  20.00 Year(s)
Gender  Both 
Details  First year undergraduate Naturopathy medical students with age group between 18-20 years, students who are appearing for the university examination, and willing to give their consent to participate were included 
 
ExclusionCriteria 
Details  Students who had alcohol or habit of using opioid or psychotropic medication within 24 hours prior to the study. Those who are having open wounds, burns, scalds, infection, inflammation in the ears and who have needle phobia were excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Hamilton Anxiety Rating Scale  The assessment will be made half an hour before the university Examination and after completion of the 3-hours of examination.  
 
Secondary Outcome  
Outcome  TimePoints 
Blood pressure and Pulse rate  The assessment will be made half an hour before the university Examination and after completion of the 3-hours of examination.  
 
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   N/A 
Date of First Enrollment (India)   23/09/2024 
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="1" 
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 - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  The data will be available in the manuscript in the form of numerical value.

  6. For how long will this data be available start date provided 15-10-2024 and end date provided 31-10-2024?
    Response - Immediately following publication. No end date.

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

According to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), anxiety is the future anticipation of unbalanced, associated with muscle tension and caution in preparation for future hazards. Its extreme condition triggers psychopathological events disturbing an everyday life.1 It is characterized by feelings of tension, worries, and negative physiological reactions.2 In educational settings, Students learning and understandings are assessed through Examination. This situation drives them into psychosomatic disturbance before, during and sometimes after exams leading to Exam anxiety. 3 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.3,4 Although some levels of anxiety are necessary for academic success, tremendous anxiety such as overwhelming emotions, stressful thoughts can hinder the ability of students to manage the stress response during writing and success in the examinations.4 The Hamilton Anxiety Rating Scale is an initial rating scales designed to assess the intensity of perceived anxiety symptoms which, identifies students with anxiety impairment 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 body6. Auriculotherapy is a branch of acupuncture, performing stimulation of specific points on external ear and balances the flow energy 7,8. Auriculotherapy is a less invasive method of stimulation of auricular branch of vagus nerve and trigeminal nerve 910. 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.11 Vagus nerve has parasympathetic control, visceral function, anxiety perception areas.7 Ear acupuncture at different points led to activation or deactivation brain structures, which seems to overlap regions belonging to the anxiety’s neurobiology.1

Previous studies observed that auricular acupuncture at tranquilizing points had induced the activation of parasympathetic nerve tone and kept the Lower Frequency /Higher Frequency ratio at lower levels in post operative patients.12 Thereby hypothesis is auriculotherapy at Shenmen and Point Zero will alleviate the exam anxiety. This study was aimed to measure immediate effect of auriculotherapy in alleviating the anxiety levels and manage the student’s stress level during the examination. Till today, there are many research study emphasising the effect of auriculotherapy on anxiety but this was to evaluate the immediate effect on exam anxiety.

 
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