| CTRI Number |
CTRI/2025/04/085763 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Which is better in reducing dental anxiety among Eye Movement Desensitization and Reprocessing Therapy and Cryotherapy in children age 6-12 years |
|
Scientific Title of Study
|
Evaluation of anxiety by eye movement desensitization and reprocessing therapy and cryotherapy in children aged 6-12 years: 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 |
Dr Chelsi Patel |
| Designation |
Post graduate student |
| Affiliation |
College of Dental Science and Hospital, Amargadh, Bhavnagar, Gujarat |
| Address |
Department of pediatric and preventive dentistry, Division P, Room No 6, College of Dental Science and Hospital, Bhavnagar Rajkot Highway, Amargadh Ta-Sihor, Dist- Bhavnagar
Bhavnagar
GUJARAT
364210
India |
| Phone |
9909977499 |
| Fax |
|
| Email |
chelsipatel236@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shital Kiran DP |
| Designation |
Professor and Head of Department in Pediatric and Preventive Dentistry |
| Affiliation |
College of Dental Science and Hospital, Amargadh, Bhavnagar, Gujarat |
| Address |
Department of pediatric and preventive dentistry, Division P, Room No 6, College of Dental Science and Hospital, Bhavnagar Rajkot Highway, Amargadh Ta-Sihor, Dist- Bhavnagar
Bhavnagar
GUJARAT
364210
India |
| Phone |
7016310949 |
| Fax |
|
| Email |
drskiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shital Kiran DP |
| Designation |
Professor and Head of Department in Pediatric and Preventive Dentistry |
| Affiliation |
College of Dental Science and Hospital, Amargadh, Bhavnagar, Gujarat |
| Address |
Department of pediatric and preventive dentistry, Division P, Room No 6, College of Dental Science and Hospital, Bhavnagar Rajkot Highway, Amargadh Ta-Sihor, Dist- Bhavnagar
Bhavnagar
GUJARAT
364210
India |
| Phone |
7016310949 |
| Fax |
|
| Email |
drskiran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, College of Dental Science and Hospital, Bhavnagar Rajkot Highway, Amargadh Ta-Sihor, Dist- Bhavnagar, Gujarat- 364210, India |
|
|
Primary Sponsor
|
| Name |
College of Dental Science and Hospital |
| Address |
College of Dental Science and Hospital, Bhavnagar Rajkot Highway, Amargadh Ta-Sihor, Dist- Bhavnagar |
| Type of Sponsor |
Private medical college |
|
|
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 Chelsi Patel |
College of Dental Sciences Amargadh |
Department of pediatric and preventive dentistry, Division P, Room No 6, College of Dental Sciences, Amargadh
Bhavnagar
GUJARAT |
9909977499
chelsipatel236@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cryotherapy |
A piece of sterile gauze will be used to dry the soft tissue site prior to intervention. Cryospray soaked cotton pellet will be kept on the site of injection for 60 seconds prior to LA administration. |
| Intervention |
Eye Movement Desensitization and Reprocessing therapy |
During dental extractions which require local anaesthesia (infiltration) in children aged 6-12 years |
| Comparator Agent |
Tender Love Care |
Behavior management will be conducted using the Tender Love Care (TLC) approach, during LA administration (infiltration) |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy children without any systemic disease
2. Children of both sexes
3. Children who require local anaesthesia (infiltration) for dental extractions
4. Children of age 6-12 years with bad memory.
|
|
| ExclusionCriteria |
| Details |
1.Children with Sinus, fistula or abscess
2.Children whose parents refuse to participate in the study.
3. The children who score more than or equal to 20 in PHQ9 (Patient Health Questionnaire).
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessment of dental anxiety in children |
before and after local anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate dental anxiety in children before & after local anaesthesia by RMS Pictorial scale & pulse oximeter in 6 to 12 years children |
2 years |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
A total of 150
children aged 6-12 year old reporting to the department of pediatric and
preventive dentistry College of Dental Sciences, Amargadh, Bhavnagar, Gujarat
to undergo dental treatment procedures which require administration of LA (infiltration)
prior to extraction after the diagnosis
and treatment plan.Written informed
consent will be obtained from the parent.
Group 1(Control
group): 50 children will be subjected to Tender Love Care therapy to
assess anxiety. Behavior management will be conducted using the Tender Love
Care (TLC) approach, during LA administration (infiltration). TLC is associated
with provision of care, attention and affection for children Group
2(Experimental 1): 50 children will be subjected to eye movement distraction
therapy to assess anxiety. Children will be asked to breathe deeply followed by
recalling their bad memory and side to side eye movement and not the neck
movement. Children will be instructed how to perform Eye Movement Desensitization and Reprocessing
therapy prior to the administration of LA (infiltration). Group
3(Experimental 2): 50 children will be subjected to cryotherapy to assess pain
perception. Cryospray soaked cotton pellet will be kept at the site of
injection for 60 seconds followed by LA administration (infiltration). This study is designed as a single blind (participants),
randomized controlled trial with two parallel groups. Sample will be randomly allocated to the study
groups by block randomization by pressure sensitive
paper envelop for equal distribution of sample size in study group.
In all the groups 2% of
lignocaine with 1:80,000
adrenaline [Lidyan, India] and 30 gauge needle [BD Microlane] will be used. In all
the study groups, anxiety will be assessed subjectively by pulse rate by using
pulse oximeter (DR VAKU) and objectively by the Raghavandera, Madhuri, Sujata
Pictorial Scale (RMS Pictorial Scale) before and immediately after LA
administration
|