Dental Attire Effect on Children's Dental Anxiety

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06122883
• Other study ID #: UDDS-Pedo-10-2023
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: May 25, 2024

Study information

• Verified date: May 2024
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: May 25, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Anxiety Disorders
• Behavior, Child
• Dental Anxiety

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (6)

Babaji P, Chauhan PP, Rathod V, Mhatre S, Paul U, Guram G. Evaluation of child preference for dentist attire and usage of camouflage syringe in reduction of anxiety. Eur J Dent. 2017 Oct-Dec;11(4):531-536. doi: 10.4103/ejd.ejd_223_17. — View Citation

Dionigi A, Sangiorgi D, Flangini R. Clown intervention to reduce preoperative anxiety in children and parents: a randomized controlled trial. J Health Psychol. 2014 Mar;19(3):369-80. doi: 10.1177/1359105312471567. Epub 2013 Jan 29. — View Citation

Festini F, Occhipinti V, Cocco M, Biermann K, Neri S, Giannini C, Galici V, de Martino M, Caprilli S. Use of non-conventional nurses' attire in a paediatric hospital: a quasi-experimental study. J Clin Nurs. 2009 Apr;18(7):1018-26. doi: 10.1111/j.1365-2702.2008.02430.x. — View Citation

Kamavaram Ellore VP, Mohammed M, Taranath M, Ramagoni NK, Kumar V, Gunjalli G. Children and Parent's Attitude and Preferences of Dentist's Attire in Pediatric Dental Practice. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):102-7. doi: 10.5005/jp-journals-10005-1293. Epub 2015 Aug 11. — View Citation

Kastelic DR, Volpato LE, de Campos Neves AT, Aranha AM, Martins CC. Do Children and Adolescents Prefer Pediatric Attire over White Attire during Dental Appointments? A Meta-analysis of Prevalence Data. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):14-29. doi: 10.5005/jp-journals-10005-1861. — View Citation

Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD006447. doi: 10.1002/14651858.CD006447.pub3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain levels	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.
Primary	Anxiety levels	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.
Primary	Anxiety levels	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
Primary	Pulse rate	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