| CTRI Number |
CTRI/2025/03/081826 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Reaction of cooperative versus non coperative children to stresses in dental clinic |
|
Scientific Title of Study
|
Comparative Evaluation of Ego Defense Mechanisms Among Cooperative and Uncooperative 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 |
Ashish Suresh |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental college, No 162, poonamalle high road, velappanchavadi, Chennai 600077, Tamil Nadu, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9884927585 |
| Fax |
|
| Email |
ashishamudha011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh R |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental college, No 162, poonamalle high road, velappanchavadi, Chennai 600077, Tamil Nadu, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9895725236 |
| Fax |
|
| Email |
drrameshravikumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramesh R |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental college, No 162, poonamalle high road, velappanchavadi, Chennai 600077, Tamil Nadu, India
TAMIL NADU
600077
India |
| Phone |
9895725236 |
| Fax |
|
| Email |
drrameshravikumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals, SIMATS University, No 162, Poonamalle High Road, Velappanchavadi, Chennai-600077, Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Ashish S S |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental college, No 162, poonamalle high road, velappanchavadi, Chennai 600077, Tamil Nadu, India |
| Type of Sponsor |
Other [Individual] |
|
|
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 |
| DrRamesh R |
Saveetha Dental College and Hospitals |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental college, No 162, poonamalle,high road, velappanchavadi, Chennai 600077, Tamil Nadu, India
Thiruvallur
TAMIL NADU |
9895725236
drrameshravikumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group/ Cooperative Children |
1.Structured play activity: where thev are asked to draw a person and explain the nature of the person in the drawing.
2.Puzzle solving activity: Children were asked to solve a difficult puzzle and asked how they felt to solve
3.Modified Comprehensive Assessment of Defence style Questionnaire was asked to fill by the parents.
4.Behaviour Challenge Test: Child was shown a syringe and were observed how they reacted to it.
5.Role Playing Activity: Patient was asked to think they are the doctor and treat the examiner as the patient
|
| Intervention |
Test group/ UnCooperative children |
1.Structured play activity: where thev are asked to draw a person and explain the nature of the person in the drawing.
2.Puzzle solving activity: Children were asked to solve a difficult puzzle and asked how they felt to solve
3.Modified Comprehensive Assessment of Defence style Questionnaire was asked to fill by the parents.
4.Behaviour Challenge Test: Child was shown a syringe and were observed how they reacted to it.
5.Role Playing Activity: Patient was asked to think they are the doctor and treat the examiner as the patient
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient reporting to the dental operatory for the first time to minimize behavioural bias
2.Patients from the age group 6 to 12
3.Children requiring pulp therapy procedures
4.Individuals without any cognitive or systemic disabilities |
|
| ExclusionCriteria |
| Details |
1.Children with prior dental experience
2.Patients with developmental or linguistic disorders who cannot communicate properly
3.Children with medications which affect behaviour
4.Medically and systematically compromised patients
5.Patients with cognitive impairments or special needs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ego defence mechanisms exhibited by children while subjected to various ego defence tests |
1.pre appointment in the waiting area
2.During treatment at chairside
3.1 week later during follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ego defense mechanisms exhibited by children |
1 week later during Recall & review |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
Final Enrollment numbers achieved (Total)= "98"
Final Enrollment numbers achieved (India)="98" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| Date of Study Completion (India) |
23/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Stress is a normal reaction to circumstances that are thought to be too much for a person to handle. Stress in young dental patients is frequently brought on by concern about being alone, fear of pain, and strange surroundings. Dental professionals may find it difficult to treat patients when they exhibit uncooperative conduct as a result of this stress.
Subconscious psychological techniques known as "ego defense mechanisms" (EDMs) are employed to control stress and anxiety. They can be roughly divided into three groups: The mechanisms are immature, neurotic, and mature. Adaptive mature defenses that facilitate successful coping include humor, sublimation, and suppression. Repression, displacement, and intellectualization are examples of neurotic strategies that are less adaptive but nonetheless effective and are frequently employed to avoid directly facing stresses. Maladaptive, immature defenses that might impede emotional growth or problem-solving include denial, regression, and projection. Since these mechanisms affect patient behavior and help practitioners customize efficient treatment techniques, it is crucial to comprehend them in healthcare settings. In times of stress, children use Ego Defense Mechanisms (EDMs) to manage their anxiety. These psychological techniques that operate subconsciously support emotional equilibrium. Denial, regression, and projection are common EDMs in children, and their use varies according to the age and emotional development of the kid. Certain processes may promote collaboration, but others may obstruct the course of treatment.
A popular instrument in pediatric dentistry for evaluating children’s cooperation and behavior during dental procedures is Frankl’s Behavior Rating Scale. The scale, which was created by Frankl et al. in 1962, assigns four different ratings to children’s behavior: Definitely Positive, Positive, Negative, and Definitely Negative. These scores are determined by the child’s general behavior in the dental office, communication with the dentist, and readiness to comply. The scale ensures a more efficient and comfortable dental experience for the child and the clinician by assisting practitioners in understanding the child’s emotional state and modifying their management techniques accordingly.
By identifying and comprehending these defense mechanisms, pediatric dentists can better customize their treatment plans to lower stress, build trust, and enhance patient results. In order to improve patient management techniques in clinical settings, this study examines the types and prevalence of EDMs used by pediatric dentistry patients according to the Frankl’s Behaviour Rating Scale.
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