| CTRI Number |
CTRI/2025/03/082043 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
09/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Color Therapy as a Non-Pharmacological Intervention for Managing Pediatric Dental Anxiety |
|
Scientific Title of Study
|
To Evaluate The Effectiveness Of Color Therapy In Managing Dental Anxiety In Children – A Randomized Control 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. Priyadharshini. S |
| Designation |
Post Graduate Student |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
6B, Paediatric and Preventive Dentistry,
Chettinad Dental College and Research Institute,
Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
9597650230 |
| Fax |
|
| Email |
dhanushpriya525@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Daya Srinivasan |
| Designation |
Professor, Head of the Department |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
6B, Paediatric and Preventive Dentistry,
Chettinad Dental College and Research Institute,
Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
9884476385 |
| Fax |
|
| Email |
dayaswathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Daya Srinivasan |
| Designation |
Professor, Head of the Department |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
6B, Paediatric and Preventive Dentistry,
Chettinad Dental College and Research Institute,
Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
9884476385 |
| Fax |
|
| Email |
dayaswathi@gmail.com |
|
|
Source of Monetary or Material Support
|
| 6B Paediatric and Preventive Dentistry
Chettinad Dental College and Hospitals
Kelambakkam
Chennai- 603103
India |
|
|
Primary Sponsor
|
| Name |
Chettinad Dental College |
| Address |
Chettinad Dental College and Research Institute
Kelambakkam
Chennai 603103 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Priyadharshini S |
Chettinad Dental College |
6B, Paediatric and Preventive Dentistry,
Chettinad Dental College and Research Institute
Kelambakkam
Chennai 603103
Chennai
TAMIL NADU |
9597650230
dhanushpriya525@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1: Blue Group |
Children will wear specially designed blue goggles. They will undergo 20 minutes of colour therapy before their dental treatment. |
| Intervention |
Group 2 :Red Colour |
Children will wear specially designed red goggles. They will undergo 20 minutes of colour therapy before their dental treatment. |
| Intervention |
Group 3: Yellow Group |
Children will wear specially designed yellow goggles. They will undergo 20 minutes of colour therapy before their dental treatment. |
| Intervention |
Group 4 : Standard Dental Environment |
Control group received no colour modification and underwent treatment in a standard dental operatory setting, providing a baseline for comparison. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients who provided with informed consent.
2)Patient diagnosed with mild to moderate dental anxiety.
3)Requiring pulpectomy or root canal treatment in mandibular teeth.
|
|
| ExclusionCriteria |
| Details |
1)Underlying medical conditions that may affect the treatment or sedation (e.g., uncontrolled asthma, heart conditions)
2)Inability to cooperate during the procedure due to developmental or behavioural issues
3)Requiring pulpectomy or root canal treatment in maxillary teeth.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in anxiety
|
Anxiety will be measured using the Dental Anxiety Scale, before baseline and after baseline, to assess any significant reduction in anxiety levels.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Salivary Amylase levels |
Saliva samples are collected from the patient before baseline & after baseline.
|
Heart Rate
|
Patient heart rate are measured before baseline & after baseline using a pulse oximeter. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/03/2025 |
| 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="0"
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
|
Introduction Dental anxiety is a common challenge among children, particularly those undergoing invasive procedures like pulpectomy or root canal treatment (RCT). Colour therapy, a non-invasive psychological intervention, has been explored as a potential method to alleviate anxiety in paediatric dental settings. This study assesses the effectiveness of colour therapy in reducing dental anxiety among children aged 6–12 years with mild to moderate anxiety undergoing treatment for mandibular teeth. Methods A randomized controlled trial will be conducted with 100 children aged 6–12 years requiring either pulpectomy or RCT in mandibular teeth. Participants will be assessed for anxiety levels using the Modified Dental Anxiety Scale (MDAS) and those categorized into mild or moderate anxiety groups will be considered. They will then be randomly assigned to either the colour therapy group (n = 75) or the control group (n = 25). The colour therapy group will be exposed to soothing colours (primary colours) in the dental operatory through coloured goggles. The control group will receive standard treatment without colour interventions. Heart rate will be measured using a pulse oximeter, and salivary samples will be collected before and after the procedure. Anxiety levels will be assessed through heart rate monitoring and salivary amylase levels to evaluate physiological stress responses.
|