Dental Attire Effect on Children's Dental Anxiety

NCT06122883 | Completed

• 1 other identifier: UDDS-Pedo-10-2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavior, Child; Dental Anxiety; Anesthesia, Local

Keywords

Dental attire; Behavior management; Children fear

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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

• 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

Study Arms (4)

Distraction in the reception area.

EXPERIMENTAL

Behavioral: 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.

EXPERIMENTAL

Behavioral: 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.

EXPERIMENTAL

Behavioral: 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.

OTHER

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

Interventions

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.

Distraction in the reception area.

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.

Distraction in the treatment area.

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.

Distraction in both treatment and reception area.

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.

Basic behavior guidance techniques without using any type of distraction aids.

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, Syria

Location

Related Publications (6)

• 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.

  PMID: 34326579 BACKGROUND

• 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.

  PMID: 26379376 BACKGROUND

• 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.

  PMID: 19284436 BACKGROUND

• 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.

  PMID: 29279683 BACKGROUND

• 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.

  PMID: 23362335 BACKGROUND

• 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.

  PMID: 26171895 BACKGROUND

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jamila Bchara, DDs

  Damascus University

  PRINCIPAL INVESTIGATOR

• Mohannad Laflof, Phd

  Damascus University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start: January 15, 2023
• Primary Completion: December 15, 2023
• Study Completion: May 25, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)