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CTRI Number  CTRI/2025/08/092518 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 06/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Other 
Public Title of Study   Assessment of Cat-Assisted Therapy in management of dental anxiety in children 
Scientific Title of Study   Efficacy of Cat-Assisted Therapy for management of dental anxiety in children 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  Shaik Anjum 
Designation  Post Graduate 
Affiliation  AMES Dental college and Hospital 
Address  Room no 4, Department of Pedodontics and Preventive dentistry,AMES Dental college and Hospital,Bijangere Road,Raichur

Raichur
KARNATAKA
584103
India 
Phone  07093342785  
Fax    
Email  faisahanjum@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shrutha SP 
Designation  Professor 
Affiliation  AMES Dental college and Hospital 
Address  Room no 4, Department of Pedodontics and Preventive dentistry,AME S Dental college and Hospital,Bijangere Road,Raichur

Raichur
KARNATAKA
584103
India 
Phone  8660091861  
Fax    
Email  shruthavinit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Raghavendra Havale 
Designation  Professor and Head of the Department 
Affiliation  AMES Dental college and Hospital 
Address  Room no 4, Department of Pedodontics and Preventive dentistry,AME S Dental college and Hospital,Bijangere Road,Raichur

Raichur
KARNATAKA
584103
India 
Phone  9448407300  
Fax    
Email  raghavendrahavale@yahoo.co.in  
 
Source of Monetary or Material Support  
Room no 4, Department of Pedodontics and Preventive Dentistry,AMES DENTAL COLLEGE AND HOSPITAL, BIJANGERE ROAD,RAICHUR,584103,KARNATAKA,INDIA 
 
Primary Sponsor  
Name  DR SHAIK ANJUM 
Address  Room no 4, Department of Pedodontics and Preventive Dentistry,AMES Dental college and Hospital,Bijangere Road, Raichur,584103,KARNATAKA,INDIA 
Type of Sponsor  Other [[SELF]] 
 
Details of Secondary Sponsor  
Name  Address 
DR SHRUTHA SP  Room no 4, Department of Pedodontics and Preventive Dentistry,AMES Dental college and Hospital,Bijangere Road, Raichur 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SHAIK ANJUM  AMES Dental college and Hospital, Bijangere Road, Raichur  Room no 4, Department of Pedodontics and Preventive dentistry,AME S Dental college and Hospital,Bijangere Road,Raichur
Raichur
KARNATAKA 		 07093342785

faisahanjum@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AME DENTAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  DENTAL ANXIETY 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Children whose dental visit is first time.
Children who are willing to participate with informed consent.Children with no cognitive disorders.  
 
ExclusionCriteria 
Details  Children who have allergic history to cats.
Children under medication that affects the CNS. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
CAT assisted therapy in management of pediatric dental patients  15 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes may include improved cooperative behavior, reduced physiological stress markers, & increased parental satisfaction.
 		 15 DAYS 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   18/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  18/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Efficacy of Animal-Assisted Therapy in the management of dental anxiety in children: A Randomized Controlled Trial

Effective pediatric dental care prioritizes treating the child as a whole, not just addressing dental problems. To achieve this, dentists employ various non-pharmacological behavioral techniques designed to enhance cooperation. Many behavior management strategies emphasize building trust and understanding between the child and the pedodontist. A significant challenge in pediatric dentistry is communication barriers with young patients. However, incorporating animals into therapy can help capture children’s attention, ease communication, and foster comfort with the dentist. One such innovative method is Animal-Assisted Therapy (AAT), which integrates animals into therapeutic settings to alleviate stress. AAT may be a useful extension to the overall behavior guidance continuum in the search for nonpharmacological/nonrestrictive alternatives.. The study examined a therapy cat’s impact on children’s physiological stress markers, pain sensitivity, and cooperative behavior during procedures.

 

 

 

 
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