NCT04833478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

March 16, 2021

Last Update Submit

April 2, 2021

Conditions

Keywords

AnxietyDental ApplicationDental SongTell-Show-DoBehaviour

Outcome Measures

Primary Outcomes (6)

  • Group 1: Little Lovely Dentist App measuring anxiety using pulse oximeter

    Measuring Anxiety Levels

    5 months

  • Group 1: Little Lovely Dentist App measuring anxiety using facial image scale.

    Measuring Anxiety Levels, 1 Minimum value and 5 Maximum value

    5 months

  • Group 2: Dental Song measuring anxiety using pulse oximeter

    Measuring Anxiety Levels

    5 months

  • Group 2: Dental Song measuring anxiety using facial image scale.

    Measuring Anxiety Levels, 1 Minimum value and 5 Maximum value

    5 months

  • Group 3: Tell-Show-Do measuring anxiety using pulse oximeter

    Measuring Anxiety Levels

    5 months

  • Group 3: Tell-Show-Do measuring anxiety using facial image scale.

    Measuring Anxiety Levels 1 Minimum value and 5 Maximum value

    5 months

Study Arms (3)

Application

EXPERIMENTAL

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

Behavioral: Anxiety

Dental Song

EXPERIMENTAL

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

Behavioral: Anxiety

Tell Show Do

EXPERIMENTAL

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

Behavioral: Anxiety

Interventions

AnxietyBEHAVIORAL

Techniques used to reduce anxiety in paediatric patients.

ApplicationDental SongTell Show Do

Eligibility Criteria

Age4 Years - 11 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Rest were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altamash Institute of Dental Medicine

Karachi, Sindh, 75500, Pakistan

Location

MeSH Terms

Conditions

Anxiety DisordersBehavior

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Hira Abbasi, BDS, Post Graduate Trainee

    Altamash Institute of Dental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 16, 2021

First Posted

April 6, 2021

Study Start

August 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 6, 2021

Record last verified: 2021-04

Locations