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Completed

NCT Number: NCT06122883

Dental Attire Effect on Children's Dental Anxiety

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.

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Key information

Conditions

Behavior, Child Anesthesia, Local Behavior Child Behavior Dental Anxiety

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous dental experience
  • Systematic or mental disorders.
  • Definitely negative or negative according to Frankel scale

Treatment and study plan

Evaluation the effectiveness of distraction in the reception area in the management of anxious pediatric patients during dental local anesthesia

Behavioral

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.

Evaluation the effectiveness of distraction in the treatment area in the management of anxious pediatric patients during dental local anesthesia

Behavioral

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.

Evaluation the effectiveness of distraction in both reception and treatment areas in the management of anxious pediatric patients during dental local anesthesia

Behavioral

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.

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

Behavioral

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.

Primary outcomes

  1. 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

  2. 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).

  3. 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').

  4. 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Nov 8, 2023
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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