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CTRI Number  CTRI/2025/12/099684 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 19/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Creating and Testing a Tool to Measure the Harmful Effects of Excessive Screen Use on Eyes and Ears in Participants, and Comparing It with a Standard Anxiety and Depression Scale (DASS-21) in People with anxiety and depression Who has a lot of screen exposure. 
Scientific Title of Study   Development and Validation of an Asatmyaindriyartha Samyoga(Chakshu indriya - Shravanindriya) Assessment Tool and A Cross-sectional comparitive study with DASS 21 w.s.r Screen time related Anxiety and Depression 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Natisha Sharma 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda ,Jaipur 
Address  National Institute of Ayurveda,madhavvilas palace Amer road,Jaipur.Rajesthan,302002
OPD 6 and 17 and SSBH OPD 3, Department of Roga Nidana Evam Vikriti Vigyana, National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India 
Phone  8219092652  
Fax    
Email  natishasharma339@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Surendra Kumar Sharma 
Designation  Professor and HOD of Dept. of Roga nidana and Vikriti Vigyana 
Affiliation  National Institute of Ayurveda Jaipur 
Address  Room no. 129, National Institute of Ayurveda,madhavvilas palace Amer road,Jaipur.Rajesthan,302002

Jaipur
RAJASTHAN
302002
India 
Phone  9414361874  
Fax    
Email  ssurendra452@gmail.com  
 
Details of Contact Person
Public Query  
Name  Natisha Sharma 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda ,Jaipur 
Address  National Institute of Ayurveda,madhavvilas palace Amer road,Jaipur.Rajesthan,302002
OPD 6 and 17 and SSBH OPD 3, Department of Roga Nidana Evam Vikriti Vigyana, National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India 
Phone  8219092652  
Fax    
Email  natishasharma339@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur, 302002, Rajasthan 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Jorawar Singh Gate, Amer Road, Jaipur, 302002, Rajasthan 
Type of Sponsor  Government medical college 
 
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 
DrNatisha Sharma  National Institute of Ayurveda Hospital ,SSBH jaipur  OPD 6 and 17 and SSBH OPD 3, Department of Roga Nidana Evam Vikriti Vigyana, National Institute of Ayurveda
Jaipur
RAJASTHAN 		 08219092652

natishasharma339@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECNIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: MANOVAHASROTOVIKARAH, (2) ICD-10 Condition:F321||Major depressive disorder, singleepisode, moderate. Ayurveda Condition: MANOVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Anxiety , depression diagnosed patients (based on ICD -10 criteria)
Individuals with daily screen time of 6 hours or more.
Individuals aged between 18- 60 Years
Willing To Provide informed consent. 
 
ExclusionCriteria 
Details  Individuals with dementia , intellectual impairment , psychotic illness
Individuals With Visual or Cognitive Impairments Affecting Screen Use
Patients on ongoing substance abuse.
Individuals with inability to understand or complete the study questionnaire 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of Extent of Asatmya Indriya Artha Samyoga among individuals with excessive screen time.

Assessment of Association between AIS tool and DASS-21 scores results. 		 At the end of the study (12 Months) 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   10/08/2026 
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="1"
Months="0"
Days="0" 
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 - NO
Brief Summary  

This study aims to develop and validate a standardized questionnaire-based tool to assess Asatmya Indriyartha Samyoga—the improper or excessive use of the visual (Chakshu) and auditory (Shravana) senses—particularly in the context of excessive screen time, which modern research links to rising anxiety and depression. Phase 1 focuses on creating the Asatmya Indriyartha Samyoga (AIS) Assessment Tool through classical Ayurvedic literature review, expert evaluation, pilot studies, and statistical validation using content validity, construct validity, and reliability testing. Phase 2 is a cross-sectional analytical study involving 400 participants diagnosed with anxiety or depression, assessing the association between prolonged screen exposure, AIS scores, and DASS-21 results. The study fills a major research gap by integrating Ayurvedic sensory stress concepts with modern psychological assessment, aiming to establish a validated tool and determine its correlation with mental health outcomes related to screen overuse.

 
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