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Comparison of Efficacy of Little Lovely Dentist, Dental Song and Tell-show-do Techniques in Alleviating Dental Anxiety in Paediatric Patients

Primary Purpose

Anxiety, Paediatric, Dental Anxiety

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Anxiety
Sponsored by
Altamash Institute of Dental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Anxiety, Dental Application, Dental Song, Tell-Show-Do, Behaviour

Eligibility Criteria

4 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Only the children age ranged from 4 to 11 years with no positive medical history.

Exclusion Criteria:

  • Rest were excluded.

Sites / Locations

  • Altamash Institute of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Application

Dental Song

Tell Show Do

Arm Description

Measuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter

Measuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter

Measuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter

Outcomes

Primary Outcome Measures

Group 1: Little Lovely Dentist App measuring anxiety using pulse oximeter
Measuring Anxiety Levels
Group 1: Little Lovely Dentist App measuring anxiety using facial image scale.
Measuring Anxiety Levels, 1 Minimum value and 5 Maximum value
Group 2: Dental Song measuring anxiety using pulse oximeter
Measuring Anxiety Levels
Group 2: Dental Song measuring anxiety using facial image scale.
Measuring Anxiety Levels, 1 Minimum value and 5 Maximum value
Group 3: Tell-Show-Do measuring anxiety using pulse oximeter
Measuring Anxiety Levels
Group 3: Tell-Show-Do measuring anxiety using facial image scale.
Measuring Anxiety Levels 1 Minimum value and 5 Maximum value

Secondary Outcome Measures

Full Information

First Posted
March 16, 2021
Last Updated
April 2, 2021
Sponsor
Altamash Institute of Dental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04833478
Brief Title
Comparison of Efficacy of Little Lovely Dentist, Dental Song and Tell-show-do Techniques in Alleviating Dental Anxiety in Paediatric Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Altamash Institute of Dental Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Paediatric, Dental Anxiety, Behaviour
Keywords
Anxiety, Dental Application, Dental Song, Tell-Show-Do, Behaviour

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Application
Arm Type
Experimental
Arm Description
Measuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter
Arm Title
Dental Song
Arm Type
Experimental
Arm Description
Measuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter
Arm Title
Tell Show Do
Arm Type
Experimental
Arm Description
Measuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter
Intervention Type
Behavioral
Intervention Name(s)
Anxiety
Intervention Description
Techniques used to reduce anxiety in paediatric patients.
Primary Outcome Measure Information:
Title
Group 1: Little Lovely Dentist App measuring anxiety using pulse oximeter
Description
Measuring Anxiety Levels
Time Frame
5 months
Title
Group 1: Little Lovely Dentist App measuring anxiety using facial image scale.
Description
Measuring Anxiety Levels, 1 Minimum value and 5 Maximum value
Time Frame
5 months
Title
Group 2: Dental Song measuring anxiety using pulse oximeter
Description
Measuring Anxiety Levels
Time Frame
5 months
Title
Group 2: Dental Song measuring anxiety using facial image scale.
Description
Measuring Anxiety Levels, 1 Minimum value and 5 Maximum value
Time Frame
5 months
Title
Group 3: Tell-Show-Do measuring anxiety using pulse oximeter
Description
Measuring Anxiety Levels
Time Frame
5 months
Title
Group 3: Tell-Show-Do measuring anxiety using facial image scale.
Description
Measuring Anxiety Levels 1 Minimum value and 5 Maximum value
Time Frame
5 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Only the children age ranged from 4 to 11 years with no positive medical history. Exclusion Criteria: Rest were excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hira Abbasi, BDS, Post Graduate Trainee
Organizational Affiliation
Altamash Institute of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altamash Institute of Dental Medicine
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75500
Country
Pakistan

12. IPD Sharing Statement

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Comparison of Efficacy of Little Lovely Dentist, Dental Song and Tell-show-do Techniques in Alleviating Dental Anxiety in Paediatric Patients

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