| 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
|
|
|
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
|
|
|
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
|
|
|
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 qiâ€: 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - The data will be available in the manuscript in the form of numerical value.
- 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.
- 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. |