- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04833478
Comparison of Efficacy of Little Lovely Dentist, Dental Song and Tell-show-do Techniques in Alleviating Dental Anxiety in Paediatric Patients
April 2, 2021 updated by: Hira Abbasi, Altamash Institute of Dental Medicine
Comparison of Efficacy of Little Lovely Dentist, Dental Song and Tell-show-do Techniques in Alleviating Dental Anxiety in Paediatric Patients -A Single Blind Randomized Controlled Trial
To evaluate the efficacy of different techniques for the reduction of dental anxiety in pediatric patients.
Generally, anxiety amongst paediatric patients is higher as compared to adult patients.
So different modalities are used by the dentists in order to reduce the anxiety of such patient to help to make treatment procedures easier and optimal.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Children who suffer from dental anxiety avoid any sort of dental treatment provided to them, which leads to poor oral hygiene, and if unaddressed, problems like missing teeth and decayed teeth further in life develop, and ultimately leading to problems making treatment planning intricate.
Children normally follow the footsteps of their parents so it is of importance to consider how to avoid creating dental anxiety among them.
If dental anxiety is left untreated, it might persist during adulthood, which eventually will deteriorate the oral health of such patients.
Due to the substantial effect of dental anxiety in paediatric patients, many methods have been devised to alleviate or eliminate such anxieties of the patients.
This study aimed to employ different strategies and measure heart rate and Facial Image Scale scores to determine their efficacy in reducing paediatric patient's dental anxiety by using these techniques before and after the procedure to compare the effectiveness of each of these techniques.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 75500
- Altamash institute of dental medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Only the children age ranged from 4 to 11 years with no positive medical history.
Exclusion Criteria:
- Rest were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Application
Measuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter
|
Techniques used to reduce anxiety in paediatric patients.
|
|
Experimental: Dental Song
Measuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter
|
Techniques used to reduce anxiety in paediatric patients.
|
|
Experimental: Tell Show Do
Measuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter
|
Techniques used to reduce anxiety in paediatric patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Group 1: Little Lovely Dentist App measuring anxiety using pulse oximeter
Time Frame: 5 months
|
Measuring Anxiety Levels
|
5 months
|
|
Group 1: Little Lovely Dentist App measuring anxiety using facial image scale.
Time Frame: 5 months
|
Measuring Anxiety Levels, 1 Minimum value and 5 Maximum value
|
5 months
|
|
Group 2: Dental Song measuring anxiety using pulse oximeter
Time Frame: 5 months
|
Measuring Anxiety Levels
|
5 months
|
|
Group 2: Dental Song measuring anxiety using facial image scale.
Time Frame: 5 months
|
Measuring Anxiety Levels, 1 Minimum value and 5 Maximum value
|
5 months
|
|
Group 3: Tell-Show-Do measuring anxiety using pulse oximeter
Time Frame: 5 months
|
Measuring Anxiety Levels
|
5 months
|
|
Group 3: Tell-Show-Do measuring anxiety using facial image scale.
Time Frame: 5 months
|
Measuring Anxiety Levels 1 Minimum value and 5 Maximum value
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hira Abbasi, BDS, Post Graduate Trainee, Altamash institute of dental medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
March 16, 2021
First Submitted That Met QC Criteria
April 2, 2021
First Posted (Actual)
April 6, 2021
Study Record Updates
Last Update Posted (Actual)
April 6, 2021
Last Update Submitted That Met QC Criteria
April 2, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Paeds Anxiety
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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