| 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
|
|
|
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
|
|
|
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
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - online access
- 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.
- 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. |