Dental Attire Effect on Children's Dental Anxiety

Sponsor
Damascus University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06122883
Collaborator
(none)
120
1
4
12.3
9.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Official Title Evaluating the Effect of Dentist's Attire on Children's Acceptance of Dental Treatment Including Local Anesthesia
Actual Study Start Date :
Jan 15, 2023
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
Jan 25, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Anxiety levels [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).

  3. 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').

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Damascus University Damascus Syrian Arab Republic

Sponsors and Collaborators

  • Damascus University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Damascus University
ClinicalTrials.gov Identifier:
NCT06122883
Other Study ID Numbers:
  • UDDS-Pedo-10-2023
First Posted:
Nov 8, 2023
Last Update Posted:
Nov 8, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Damascus University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 8, 2023