Dental Attire Effect on Children's Dental Anxiety

Not Applicable

Completed

• Conditions: Behavior, Child; Anesthesia, Local; Dental Anxiety
• Interventions: Behavioral: Evaluation the effectiveness of distraction in the reception area in the management of anxious pediatric patients during dental local anesthesia; Behavioral: Evaluation the effectiveness of distraction in the treatment area in the management of anxious pediatric patients during dental local anesthesia; Behavioral: Evaluation the effectiveness of distraction in both reception and treatment areas in the management of anxious pediatric patients during dental local anesthesia; 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

• Registration Number: NCT06122883
• Lead Sponsor: Damascus University

Brief Summary

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.

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 Timeline

• Study Start: 2023-01-15
• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2023-11-03
• Study First Posted: 2023-11-08
• Primary Completion: 2023-12-15
• Study Completion: 2024-05-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-07
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distraction in the reception area.	Evaluation the effectiveness of distraction in the reception area in the management of anxious pediatric patients during dental local anesthesia	-
Distraction in the treatment area.	Evaluation the effectiveness of distraction in the treatment area in the management of anxious pediatric patients during dental local anesthesia	-
Distraction in both treatment and reception area.	Evaluation the effectiveness of distraction in both reception and treatment areas in the management of anxious pediatric patients during dental local anesthesia	-
Basic behavior guidance techniques without using any type of distraction aids.	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	-

Primary Outcome Measures

Name	Time	Method
Pain levels	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
Anxiety levels	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').
Pulse rate	(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.

Trial Locations

Locations (1)

Damascus University; 🇸🇾 Damascus, Syrian Arab Republic