NCT06241157

Brief Summary

Behavior orientation is the cornerstone of the success of pediatric dentistry. The use of behavior management techniques enables children to learn appropriate behavior and coping skills, reduce anxiety, and facilitate the delivery of adequate oral health care. Some behavior guidance systems have been tried to be created. On the basis of the magic game, it has been tried to move the children away from the current real situation, the reality of dental treatment, to move forward in communication and successful results have been obtained. The main thing in the technique is to start the communication with the child in the waiting room of the dentist and to reduce the anxiety of the child by improving the self-efficacy perception of the child. The aim of this study is to investigate the effectiveness of question-answer behavior guidance technique in dental treatment in pediatric patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

January 5, 2024

Last Update Submit

March 3, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • The Visual Analogue Scale (VAS)

    Participants' pain and anxiety levels were assessed. The scale displayed a colored spectrum on the front side ranging from no pain (white) to severe pain (red), which indicates relevant pain scores ranging from 0 to 10 on the reverse side.

    3 Months

  • The Dental Subscale of Children's Fear Survey Schedule parental version (CFSS-DS pv)

    The Scale consists of 15 articles. The answers are given by parents on a Likert type scale, ranging from 15 to 75. For children with moderate and severe dental fear levels, threshold values are set as 32 and 38 points, respectively.

    3 months

  • The Venham Picture Test (VPT), a self-reporting scale

    The scale is used to evaluate children's situational anxiety. It consists of 16 illustrations in pairs.Among the pairs, one represents the presence of anxiety and the other represents absence of anxiety. Children's anxiety scores were calculated between 0 and 8, according to the illustration they chose, representing themselves. Higher scores indicate the presence of anxiety and its level.

    3 months

  • Facial Image Scale (FIS).

    Self-report scale will be used in the study to evaluate children's state of anxiety. It displays nine faces showing emotions ranging from "non-anxious" to "very anxious." Participants are requested to indicate the face that represents their actual feelings. The scores range between 0.04 (positive/nonanxious) and 0.97 (negative/very anxious), demonstrating the state anxiety.

    3 months

Study Arms (2)

Pediatric Quiz Game

EXPERIMENTAL

Behavior Guidance Technique (BGT) group (Pedo-Quiz group) Whereas, with the novel BGT so called "The Pediatric-Quiz Game" (PQ), dentists start interacting with children in the waiting room before entering the operating room. It can be defined as "asking children basic questions on colors, animals, fruits and/or cities depending on the age of the child. Each child will be asked to fill out the "Facial Affective Scale" and the "Venham Picture Test" before the procedure. After the session, the Frankl Behavior Scale and the "Patient Evaluation Form" will be filled out by the dentist. Their families (parents/guardians) will be asked to fill out the "Child Fear Assessment Scale-Dental Subscale (CFSS-DSc) before the session. 35 children will be included in the study.Main goal in this sesion is to evaluate in which dental practice step can be progressed in an anxious child by using this new behavior managament technique.

Other: Pediatric Quiz Game

Control

NO INTERVENTION

This group is the control group. Tell-show-do technique, which is a frequently used behavioral management techniques will be used. In this group, each child will be asked to fill out the "Facial Shape Scale" and the "Venham Picture Test" before the procedure. After the session, the Frankl Behavior Scale and the "Patient Evaluation Form" will be filled out by the dentist. Their families (parents/guardians) will be asked to fill out the "Child Fear Assessment Scale-Dental Subscale (CFSS-DSc) before the session. 35 children will be included in the study. Main goal in this sesion is to evaluate in which dental practice step can be progressed in an anxious child by using classical behavior managament technique.

Interventions

Investigator will start interacting with children upon their arrival and during their presence in the waiting room before entering the operating room. This will help to obtain better cooperation (frankl scale) and anxiety reductions (FIS and VPT) at different stages of the dental examination (e.g., entering the clinic, sitting on the dental chair, opening mouth, examination with mirror, probe, use of low-high-speed handpieces, ITR restoration). Pediatric Quiz is actually an ice-breaking quiz game developed for children, with the promise of a surprise gift at the end. It can be defined as "asking children basic questions on colors, animals, fruits and/or cities depending on the age of the child among which the child would choose him/herself and answer the question easily.

Pediatric Quiz Game

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children of age group 4-8 years.
  • with no previous dental experience.
  • without any systemic or mental disorders.

You may not qualify if:

  • Children or their families that could not agree to participate the study
  • They had a previous serious dental experience in need of emergency treatment
  • Having systemic or mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University, Faculty of Dentistry, Department of Pediatric Dentistry

Istanbul, Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (3)

  • Shahnavaz S, Hedman-Lagerlof E, Hasselblad T, Reuterskiold L, Kaldo V, Dahllof G. Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Dental Anxiety: Open Trial. J Med Internet Res. 2018 Jan 22;20(1):e12. doi: 10.2196/jmir.7803.

  • Peretz B, Gluck G. Magic trick: a behavioural strategy for the management of strong-willed children. Int J Paediatr Dent. 2005 Nov;15(6):429-36. doi: 10.1111/j.1365-263X.2005.00668.x.

  • Grisolia BM, Dos Santos APP, Dhyppolito IM, Buchanan H, Hill K, Oliveira BH. Prevalence of dental anxiety in children and adolescents globally: A systematic review with meta-analyses. Int J Paediatr Dent. 2021 Mar;31(2):168-183. doi: 10.1111/ipd.12712. Epub 2020 Sep 9.

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the intervention, the study was conducted as an open-label trial, with neither participants, care providers, nor outcome assessors blinded
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This pilot study followed a two-arm, parallel-group non-randomized controlled design and compared the effectiveness of the Pediatric Quiz Game (PQ) technique with the traditional Tell-Show-Do (TSD) method in reducing dental anxiety and improving cooperation in children.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2024

First Posted

February 5, 2024

Study Start

January 21, 2022

Primary Completion

April 20, 2024

Study Completion

May 1, 2024

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations