NCT04262063

Brief Summary

Assessment of the effectiveness of tell play do technique and tell show do technique in management of anxious children .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 14, 2020

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

February 2, 2020

Last Update Submit

July 13, 2020

Conditions

Keywords

tell show dotell play dodental anxietychild behavior

Outcome Measures

Primary Outcomes (1)

  • level of anxiety

    The level of dental anxiety of each patient will be assessed using finger pulse oximeter.

    Immediate In the first visit

Secondary Outcomes (3)

  • change in behavior

    immediate after the behavior management

  • Ease of handling patients

    immediate the end of the treatment

  • Ease of doing the procedures

    immediate at the end of the treatment

Study Arms (2)

tell play do technique

EXPERIMENTAL

Tell play do technique with a dental imitation toy and using euphemisms instead of demonstrating on a model or observing one. Tell play do technique provides a better explanatory concept of the dental procedure and can lead to more cooperation of the children patients which can influence the dental treatment in a good and positive way.

Behavioral: Tell play do technique

tell show do technique

ACTIVE COMPARATOR

Tell show do is the gold standard of the non-pharmacological behavior management techniques. It is based on the principle of learning theory and it is performed by the dentists themselves . It is the most important behavior modification technique practiced by dentists and it is commonly used for management of children anxiety in the first dental visit .

Behavioral: tell show do

Interventions

it apply the concept of learning by doing .children will enjoy playing with customized dental models

tell play do technique
tell show doBEHAVIORAL

Tell: your dentist explaining to you what they'd like to do Show: showing you what is involved (e. g. showing the equipment and demonstrating it on a finger) Do: performing the procedure

tell show do technique

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with Frankl's behavior rating score of 1,2 .
  • Patients with no previous dental experience.
  • Patients not suffering from cognitive or mental problems.
  • Children with primary molars indicated for extraction .
  • Age 4- 6 years old .

You may not qualify if:

  • Medically compromised patients
  • Patients suffering from cognitive or mental problems
  • Patients with previous dental experience

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

sara mahmoud, phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patients, their parents and the statistician will be blinded ,
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel group two arms superiority trial with 1:1 allocation ratio
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 2, 2020

First Posted

February 10, 2020

Study Start

December 1, 2020

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

July 14, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share