NCT06970613

Brief Summary

This study aimed to determine the effects of two different methods in reducing dental anxiety in children. The secondary aim of our research was to determine the levels of dental anxiety in children and the factors that may be related to it.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 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

June 17, 2022

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

3 years

First QC Date

April 20, 2025

Last Update Submit

June 20, 2025

Conditions

Keywords

Pediatric Dental AnxietyDental anxietyPet Therapy

Outcome Measures

Primary Outcomes (2)

  • Modified Child Dental Anxiety Scale (MCDASf)

    It consists of eight questions, each addressing a specific dental procedure or situation. For each question, children are asked to rate their anxiety using a set of five facial expressions, ranging from relaxed/happy to very worried/scared. Each face corresponds to a numerical score from 1 to 5:1=Not worried at all,2=A little worried,3=Quite worried,4=Very worried,5=Really worried Children select the face that best matches their feelings for each question. The total score is calculated by summing the scores for all eight items, giving a possible range from 8 to 40:A total score of 8 indicates no dental anxiety. A total score of 40 indicates extreme dental anxiety.

    Baseline (T1)

  • Modified Child Dental Anxiety Scale (MCDASf)

    It consists of eight questions, each addressing a specific dental procedure or situation. For each question, children are asked to rate their anxiety using a set of five facial expressions, ranging from relaxed/happy to very worried/scared. Each face corresponds to a numerical score from 1 to 5:1=Not worried at all,2=A little worried,3=Quite worried,4=Very worried,5=Really worried Children select the face that best matches their feelings for each question. The total score is calculated by summing the scores for all eight items, giving a possible range from 8 to 40:A total score of 8 indicates no dental anxiety. A total score of 40 indicates extreme dental anxiety.

    Immediately after the local anaesthesiat (T3)

Secondary Outcomes (4)

  • Face, legs, activity, cry, consobility (FLACC) test

    During the local anaesthesia (T2)

  • Venham Picture Test

    Baseline (T1)

  • Venham Picture Test

    Immediately after the local anaesthesiat (T3)

  • Wong-Baker Faces pain rating scale

    Immediately after the local anaesthesiat (T3)

Study Arms (2)

Watching cartoons

EXPERIMENTAL

Non-pharmacological behavioral guidance techniques and cartoons will be watched as a distraction method.

Behavioral: Watching cartoons

Robot Cat

EXPERIMENTAL

Non-pharmacological behavioral guidance techniques and a robot cat will be used as a distraction method.

Behavioral: Robot cat

Interventions

While watching the cartoons, local anesthesia will be applied and restorative treatments will be completed.

Watching cartoons
Robot catBEHAVIORAL

Local anesthesia will be applied with the robot cat in their lap during the treatment and their restorative treatments will be completed.

Robot Cat

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Between the ages of 6-10
  • Systemically and mentally healthy
  • Not allergic to local anesthetics
  • Not afraid of pets
  • In need of restorative treatment
  • No spontaneous pain complaints
  • Parents who agreed to participate in the study

You may not qualify if:

  • Children with previous complaints of severe spontaneous pain
  • Teeth requiring endodontic treatment
  • Children who are definitely negative according to the Frankl behavior scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydin Adnan Menderes University

Aydin, Efeler, 09100, Turkey (Türkiye)

Location

Study Officials

  • Rahsan Cevik Akyil, Prof. Dr.

    Aydin Adnan Menderes University

    STUDY DIRECTOR
  • Bahar Melis AKYILDIZ, Phd

    Aydin Adnan Menderes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study is an experimental, controlled randomized study.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

April 20, 2025

First Posted

May 14, 2025

Study Start

June 17, 2022

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations