Dental Attire Effect on Children's Dental Anxiety

May 1, 2024 updated by: Damascus University

Official Title Evaluating the Effect of Dentist's Attire on Children's Acceptance of Dental Treatment Including Local Anesthesia

The aim of this study is to evaluate the effect of friendly attire on dental anxiety among children visiting dental office in comparison with conventional attire. All of the children who will be experienced maxillary dental anesthesia with/without distraction will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate, and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator") Acceptance will be measured using a two-point Likert scale.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the effect of dental attire on children's acceptance of different dental treatments that include dental anesthesia. pain and anxiety will be evaluated during buccal and palatal infiltration using five behavioral scales, Wong-Baker pain scale, Children's Fear Scale and Children's Anxiety Questionnaire (self-report), pulse rate (physiological) and behavior (using FLACC behavior rating scale "external evaluator".

Heart pulse rate measurement will be recorded firstly when the patient is seated comfortably in the reception area, on dental chair prior to the injection, and finally after the procedure is done and the child patients will be asked to choose a face that describe their status from one of both Wong Baker faces scale, Children's Fear Scale and Children's Anxiety Questionnaire.

Body responses of all child patients will be recorded during the whole procedure and then will be evaluated by an external evaluator to determine the children behavioral score according to FLACC scale.

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

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age between 6 and 10 years.
  2. No previous dental experience.
  3. Definitely positive or positive according to Frank scale.
  4. Need of maxillary anesthesia for any dental treatment.

Exclusion Criteria:

  1. Previous dental experience
  2. Systematic or mental disorders.
  3. Definitely negative or negative according to Frankel scale

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: Distraction in the reception area.
Behavioral: Evaluation the effectiveness of distraction in the reception area in the management of anxious pediatric patients during dental local anesthesia
Buccal and palatal infiltration will be administrated with basic behavior guidance techniques while the dentist wearing conventional attire in the treatment room after meeting the child in the reception area while wearing the friendly attire.
Experimental: Distraction in the treatment area.
Behavioral: Evaluation the effectiveness of distraction in the treatment area in the management of anxious pediatric patients during dental local anesthesia
Buccal and palatal infiltration will be administrated with basic behavior guidance techniques while the dentist wearing friendly attire in the treatment room after meeting the child in the reception area while wearing the conventional attire.
Experimental: Distraction in both treatment and reception area.
Behavioral: Evaluation the effectiveness of distraction in both reception and treatment areas in the management of anxious pediatric patients during dental local anesthesia
Buccal and palatal infiltration will be administrated with basic behavior guidance techniques while the dentist wearing friendly attire in the reception area and treatment room.
Other: Basic behavior guidance techniques without using any type of distraction aids.
Behavioral: Evaluation of the effectiveness of basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during dental local anesthesia
Buccal and palatal infiltration will be administrated with basic behavior guidance techniques while the dentist wearing conventional attire in the reception area and treatment room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain levels
Time Frame: 5 minutes following the dental local anesthesia.

Pain levels will be measured by using a self-reported simplified Wong-Baker faces pain scale:

0 no Hurt - 1 Hurts little Bit - 2 Hurts little More - 3 Hurts Even More - 4 Hurts Whole Lot - 5 Hurts Worst
5 minutes following the dental local anesthesia.
Anxiety levels
Time Frame: 1 minute during the dental local anesthesia.
This will be evaluated using the Face-Legs-Activity-Cry-Consolability (FLACC) scale (0 low anxiety and pain level - 10 high anxiety and pain level).
1 minute during the dental local anesthesia.
Anxiety levels
Time Frame: 5 minutes following the meeting with the dentist in the reception area, and 5 minutes after the patient is seated comfortably on the dental chair
This will be evaluated using Children's Fear Scale (0 indicating 'no anxiety' and 4 indicating 'extreme anxiety') and Children Anxiety Questionnaire (self-report) (4 indicating 'no anxiety' and 16 indicating 'extreme anxiety').
5 minutes following the meeting with the dentist in the reception area, and 5 minutes after the patient is seated comfortably on the dental chair
Pulse rate
Time Frame: (1) five minutes after the patient is seated comfortably in the reception area, (2) five minutes after the patient is seated comfortably on the dental chair, (3) five minutes following the injection of the anesthetic drug
Pulse rate (the number of times your heart beats each minute bpm will be evaluated using Finger Pulse Oximeter.
(1) five minutes after the patient is seated comfortably in the reception area, (2) five minutes after the patient is seated comfortably on the dental chair, (3) five minutes following the injection of the anesthetic drug

Collaborators and Investigators

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

Sponsor

Damascus University

Investigators

  • Principal Investigator: Jamila Bchara, DDs, Damascus University
  • Study Director: Mohannad Laflof, Phd, Damascus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 15, 2023

Primary Completion (Actual)

December 15, 2023

Study Completion (Estimated)

May 25, 2024

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Pedo-10-2023

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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