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CTRI Number  CTRI/2024/06/069177 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 18/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Correlation Of Mothers emotional intelligence with autistic children during dental treatments 
Scientific Title of Study   Correlation of Mothers Emotional Intelligence with the Dental behavior of Autistic children 
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 Sruthy Sreenivasan 
Designation  Post Graduate Student 
Affiliation  Institute of dental studies and technologies MODINAGAR 
Address  Institute of Dental Studies and Technologies Department of Pediatrics and Preventive dentistry(room no 5) KADRABAD MODINAGAR GHAZIABAD

Ghaziabad
UTTAR PRADESH
201201
India 
Phone  9496717113  
Fax    
Email  dr.sruthy1617@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nidhi Agarwal 
Designation  Professor and Head of the Department 
Affiliation  IDST MODINAGAR 
Address  Department of Pediatric and Preventive Dentistry Institute of Dental Studies and Technologies Kadrabad Modinagar

Ghaziabad
UTTAR PRADESH
201201
India 
Phone  9871262302  
Fax    
Email  doc.nagarwal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sruthy Sreenivasan 
Designation  Post Graduate Student 
Affiliation  IDST Modinagar 
Address  Institute of Dental Studies and Technologies Department of Pediatric and Preventive Dentistry Kadrabad Modinagar

Ghaziabad
UTTAR PRADESH
201201
India 
Phone  9496717113  
Fax    
Email  dr.sruthy1617@gmail.com  
 
Source of Monetary or Material Support  
Institute of Dental Studies and Technologies modinagar kadrabad ghaziabad  
 
Primary Sponsor  
Name  Dr Sruthy Sreenivasan 
Address  Institute of Dental Studies and Technologies Modinagar Kadrabad Ghaziabad 2021201 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
nil   
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 
drsruthy sreenivasan  Institute of Dental Studies and Technologies  Department of Pediatrics and Preventive Dentistry Room no 5 kadrabad modinagar
Ghaziabad
UTTAR PRADESH 		 9496717113

dr.sruthy1617@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F064||Anxiety disorder due to known physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  children of age group 8-12years having autism sprectrum disorder and requiring dental treatment 
 
ExclusionCriteria 
Details  mothers who are not willing to participate 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Utilizing the Emotional intelligence quotient as a non-invasive tool to assess the Anxiety and Behavior of the child in the dental operatory  1 day 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   01/07/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   Emotional Intelligence is the ability to monitor and manage ones own emotions and feelings and to be able to use it to guide ones thinking and actions. Autism spectrum disorder is a neuro developmental disorder that is characterized by recurrent difficulties with social communication, narrow interests and repetitive conduct. globally about 1 of 68 children have been diagnosed with autism. the behavior and anxiety levels of children is greatly impacted by emotional intelligence status of the mothers . mothers coping ability with dental treatment need of her autistic child may potentially add on to stress of imparting dental treatment by the dentist. mothers who have stable and positive moods are more supportive of functional improvements in their children. parents of children with autism . face several challenges that affect their quality of life.
the psychological assessment of emotional intelligence of mother and anxiety and behavior of child is an important parameter. As a pediatric dentist, it is essential to provide early intervention and prevention to develop better behavior and anxiety management strategies tailored to the need of the child. This study thus incorporates all the elements of pediatric triangle and utilizes a holistic approach towards improving lives of autistic children. thus the aim of the study is to evaluate the relation between mothers emotional intelligence with the behavior and anxiety of their autistic children in dental operatory.
 
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