| CTRI Number |
CTRI/2024/04/066071 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assesment of using of newer methods of calming dental anxiety children in dental clinic using combination of senses |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of a novel technique of dual sensory stimulation on dental anxiety and behaviour among pediatric patients- 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 |
Namrata Puri |
| Designation |
Post graduate student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Q block, Basement- room no. 9, Department of Pediatric & Preventive Dentistry
Manav Rachna Dental College, Sector 43, Faridabad, Haryana Q block, Basement- room no. 9, Department of Pediatric & Preventive Dentistry
Manav Rachna Dental College, Sector 43, Faridabad, Haryana Faridabad HARYANA 121004 India |
| Phone |
8527741494 |
| Fax |
|
| Email |
namratapuri@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Gauri Kalra |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Q block, Basement- room no. 9, Department of Pediatric & Preventive Dentistry
Manav Rachna Dental College, Sector 43, Faridabad, Haryana Q block, Basement- room no. 9, Department of Pediatric & Preventive Dentistry
Manav Rachna Dental College, Sector 43, Faridabad, Haryana Faridabad HARYANA 121004 India |
| Phone |
9910329898 |
| Fax |
|
| Email |
gaurikalra.sds@mrei.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Gauri Kalra |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Q block, Basement- room no. 9, Department of Pediatric & Preventive Dentistry
Manav Rachna Dental College, Sector 43, Faridabad, Haryana Q block, Basement- room no. 9, Department of Pediatric & Preventive Dentistry
Manav Rachna Dental College, Sector 43, Faridabad, Haryana Faridabad HARYANA 121004 India |
| Phone |
9910329898 |
| Fax |
|
| Email |
gaurikalra.sds@mrei.ac.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College
Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana 121004 |
|
|
Primary Sponsor
|
| Name |
Namrata Puri |
| Address |
Q block, Basement- room no. 9, Manav Rachna Dental College, Sector 43, Faridabad, Haryana |
| 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 Namrata Puri |
Manav Rachna Dental College |
department of pediatric and preventive dentistry, Q block, Basement- room no. 9, Manav Rachna Dental College, Sector 43, Faridabad, Haryana Faridabad HARYANA |
8527741494
namratapuri@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
dental decay |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Audio- visual sensory stimulation |
Visual - darkening curtains will be placed on the windows.
Slow moving visual color effects will be shown onto the ceiling in the childs visual field.
The dental practitioner will wear a head-mounted lamp directed into the childs mouth, reducing bright lights shining in the childs eyes
Auditory: rhythmic music will be played through portable speakers.
The dual sensory effect is created using the audio-visual sensory distraction.
After the child is familiar with the environment, the operating dentist will begin the restorative treatment.
Once the restorative treatment is completed, postoperative anxiety will be assessed. The duration of the teatment will be 30 minutes and first dental visit
|
| Comparator Agent |
tell show do |
The child will be seated comfortably on the dental chair for the restorative procedure.
Before initiating the procedure, the child will be explained about the procedure in a language they would comprehend and a demonstration will be given before the start of the procedure.
Following which, without deviating from what was explained and demonstrated, the procedure will be performed.
Once the child is comfortable, the operating dentist will start the procedure and on completion of the restorative procedure, the post-operative
anxiety will be assessed.
The duration of the treatment will be 30 minutes and first dental visit of the patient
|
| Intervention |
visual olafactory sensory stimulation |
Visual : Visual - darkening curtains will be placed on the windows.
Slow moving visual color effects will be shown onto the ceiling in the childs visual field.
The dental practitioner will wear a head-mounted lamp directed into the childs mouth, reducing bright lights shining in the childs eyes
Olfactory : The natural essential oil of jasmine will be used to perform the aromatherapy.
An electric diffuser will be employed to diffuse the essential oil in the dental operatory room, till a sufficient level of the pleasant smell of jasmine is achieved.
The dual sensory effect is created using the visual- olfactory sensory distraction.
The child will be seated on the dental chair, following which the dental procedure is initiated.
Once the restorative treatment is completed, postoperative anxiety will be assessed. The duration of the treatment will be 30 minutes and first dental visit of the patient
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children of age group 4-7 years
First dental visit
Children who are rated as Frankl +ve or Frankl –ve according to the Frankl Behaviour Rating Scale
Patient with class I and class II caries extending 1.5 to 2 mm into the dentin that qualifies for restoration.
|
|
| ExclusionCriteria |
| Details |
Children with special healthcare needs.
Children with sensory disabilities.
Subjects experiencing dental pain.
History of chronic illness.
Known allergy to an essential oil (jasmine).
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effectiveness of audio - visual distraction technique and visual- olfactory distraction technique in reducing anxiety among children undergoing a restorative procedure |
anxiety levels will be assessed pre and post operatively
no follow ups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to check the reduction in dental anxiety using audio visual & visual olfactory distraction technique by checking physiological parameters- pulse rate & anxiety levels using chota bheem chutki scale, veham picture test & frankle behaviour rating
|
the anxiety levels will be checked pre & post operatively.
no follow ups. |
|
|
Target Sample Size
|
Total Sample Size="138" Sample Size from India="138"
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)
|
01/05/2024 |
| 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)
|
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
|
Fear and anxiety toward the dentist and dental treatment are common problems faced by Paediatric dentist and therefore it is important to explore alternative methods to reduce them. Dental anxiety has been contemplated as an obstacle in rendering quality dental care. The successful management of these children depends on the ability of the dentist to guide the children through their dental experiences by selecting behavior managment strategies that will allay their fears and bring about a positive change. In a pediatric dental setup, the sight of needles, drilling sounds, bitter taste of anaesthesia, smells of cut dentin and eugenol along with the sensation of a high frequency of vibration, are usually anxiety provocation factors. It is necessary to overcome facets like anxiety-producing sounds , smell and taste the pediatric patients. In order to do so, understanding patient’s perspective is an important step, to formulate patient centric plan. In such situations, subjective evaluation by interviews and self-reporting on fear and anxiety scales and objective of pulse rates, pulse oximetry can greatly enhance the diagnosis and unable categorization of these children/ patients. In recent times, the attitude of parents as well as of dental professional with respect to traditional behavior management techniques such as immobilization in a papoose board is refurbishing. Parents are getting more and more apprehensive about pharmacological methods for behaviour management of their children due to unwanted medical risks associated with it. As a result of that, clinicians around the world have developed non-aversive techniques. Therefore, finding effective strategies to reduce anxiety during dental visits is clinically important for promoting the oral health and well-being of children. aim of study is to evaluate and compare the effect of a novel technique of dual sensory stimulation audiovisual versus visual olfactory on dental anxiety and behaviour for pediatric patients aged 4-7years. The selection of cases will be done based on inclusion and exclusion criteria. The treatment protocol will be explained to all the patients and their guardians. The study will be conducted among 138 children in age group 4-7 years visiting Out Patient Department of Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College, Faridabad. Demographic data including age, sex and education will be noted. Written informed consent will be taken from the guardians. ASSESSMENT OF PRE OPERATIVE ANXIETY The child’s pulse rate and oxygen saturation will be recorded manually with the help of pulse oximeter. The child will then be questioned using CBCS (Chota Bheem Chutki Scale) and Venham’s Picture Test EXAMINATION OF SUBJECT The subjects were made to sit comfortably. Intra-oral examination was done wearing mouth mask and sterile latex gloves. The clinical intra oral examination of the subjects will be done and behavior of the child was assessed using Frankl’s behavior rating scale. Children displaying Frankl’s 2 and 3 level of behavior will be selected for the study.The 138 study participants will be randomized using Graph Pad Prism online software in three different groups (N=46). The children will be grouped in Group A, B and C according to the distraction method to be used. Each group will have 46 children. The selected participants will then be taken into the dental operatory room prepared for the child. |