Effectiveness of TPD Tech VS TSD Tech

July 13, 2020 updated by: rehab abdulhameed ebrahim mohammed

Effectiveness of Tell Play do Technique in Comparison to Tell Show do Technique for the Management of Anxious Children: A Randomized Controlled Trial

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

Study Overview

Status

Unknown

Conditions

Detailed Description

Child dental anxiety has been a matter of concern for many years. It is defined as a nonspecific feeling of apprehension, worry, uneasiness and the source may be not clear or unknown .

Dental anxiety is considered as a major obstacle for the dental treatment. The dental appointment is a stressful situation specially for children which raises their anxiety level. Different studies among 6-12 years old children showed that 20%- 43 % exhibited high dental fear and anxiety .

Dental fear and anxiety can have negative implications for children's oral health. There is certainty for the negative impact of dental anxiety on the oral health-related quality of life of children, and studies have shown that children with dental fear and anxiety have worse oral health status than their peers (more untreated carious lesions).

It is also children with dental fear and anxiety may present with behavioral management problems which can disrupt the provision of dental treatment and negatively impact on the dental treatment the child receives. The anxiety experienced by children is not only distressing for the child, but it can also be a potentially stressful and upsetting experience for their parents .

A good patient-dentist relationship is crucial for the management of anxiety. It is the responsibility of pedodontists to make dentistry as child-friendly and pain-free as possible to bring about positive changes in the behavior of children during dental treatment .

Tell-show-do technique is widely used for managing pediatric dental patients. It is useful for almost all patients who can communicate, especially those patients who are 'monitors. Although widely used, the ability of this technique to prepare, and reduce child anxiety remains an area for research, because it's not always appropriate for those patients who are 'blunters' where detailed information can result in increased levels of anxiety .

So different modifications of this technique were used one of them is 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.

Study Type

Interventional

Enrollment (Anticipated)

34

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 Contact

Study Contact Backup

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 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Medically compromised patients
  2. Patients suffering from cognitive or mental problems
  3. Patients with previous dental experience

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tell play do technique
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.
it apply the concept of learning by doing .children will enjoy playing with customized dental models
Active Comparator: tell show do technique
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 .
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of anxiety
Time Frame: Immediate In the first visit
The level of dental anxiety of each patient will be assessed using finger pulse oximeter.
Immediate In the first visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in behavior
Time Frame: immediate after the behavior management

the operator will grade the child's behavior during the procedure using the (Face, Leg, Activity, Cry, Consolability) behavioral pain assessment scale.(FLACC)

each category scores from 0-2 scale which result in a total score of 0-10

0 relaxed and comfortable 1-3 mild discomfort 4-6 moderate pain 7-10 severe discomfort of pain or both

immediate after the behavior management
Ease of handling patients
Time Frame: immediate the end of the treatment
The ease of handling the patient will be assessed using a validated questionnaire by 5-point Likert scale (1- Strong positive , 2- Positive, 3- Neutral , 4- Negative,5- Strong negative)
immediate the end of the treatment
Ease of doing the procedures
Time Frame: immediate at the end of the treatment
the ease of doing the procedures will be assessed using a validated questionnaire by 5-point Likert scale (1- Strong positive , 2- Positive, 3- Neutral , 4- Negative, 5- Strong negative)
immediate at the end of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

February 2, 2020

First Submitted That Met QC Criteria

February 6, 2020

First Posted (Actual)

February 10, 2020

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • eff of TPD vsTSD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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