NCT06463067

Brief Summary

The objective of this study was to examine the impact of educational video viewing, reading educational books, and playing educational mobile games on children's dental anxiety prior to dental examinations. The main questions it aims to answer are:

  1. 1.Does reading educational books before dental examinations reduce dental anxiety in children?
  2. 2.Does watching educational videos before dental examinations reduce children's dental anxiety?
  3. 3.Does playing educational mobile games before dental check-ups reduce dental anxiety in children?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at 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 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
Last Updated

June 17, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

May 17, 2024

Last Update Submit

June 13, 2024

Conditions

Dental AnxietyChild, Only

Keywords

bookDental anxietyBehavior managementvideomobil game

Outcome Measures

Primary Outcomes (1)

  • anxiety level according to the child

    We evaluated the effects of reading informative books, playing mobile games and watching videos after the dental examination on dental anxiety by measuring the Facial Image Scale (In the facial image scale consisting of 5 different faces, the happiest face is given a value of 1 while the unhappiest face is given a value of 5 and scoring is done according to the face chosen by the children.)

    after dental examination to 10 minute

Secondary Outcomes (1)

  • child's anxiety level according to the researcher

    after dental examination to 30 minute

Other Outcomes (2)

  • child's level of dental anxiety from the parents' perspective

    after dental examination to 24 hour

  • children's anxiety levels according to heart rate

    after dental examination to 2 minute

Study Arms (4)

Play group

OTHER

Before the examination process, the child was asked to select one of the five faces on the Facial Image Scale. The dentist evaluated and scored the patient's behaviors based on the categories in the Frankl Behavior Scale. Parents were asked to answer the questions in the Corah Dental Anxiety Scale on behalf of their children to assess their dental anxiety, and results were scored. Subsequently, the children's heart rate was measured and recorded with a pulse oximeter attached to the index finger of the left hand. Prior to the examination procedure, The patients in Play Group played a mobile game called 'Dentist' before the examination. After that patients were examined, and their anxiety levels were assessed using the same methods following the examination procedure

Behavioral: playing mobile game

Book group

OTHER

Before the examination, the child was asked to choose one of five faces from the Facial Image Scale. The dentist assessed and scored the patient's behaviour using the Frankl Behaviour Scale. Parents were asked to complete the Corah Dental Anxiety Scale on behalf of their children to assess their dental anxiety and the results were scored. The children's heart rate was then measured and recorded using a pulse oximeter attached to the index finger of the left hand. The researcher then read the storybook "Elif Goes to the Dentist" and showed the children pictures of dental instruments as described in the book. Behavioural techniques were used to examine the patients, and their anxiety levels were assessed after the examination using the same methods.

Behavioral: reading book

Video group

OTHER

Before the examination, the child was asked to choose one of the five faces on the Facial Image Scale. The dentist assessed the patient's behaviour using the Frankl Behaviour Scale. Parents were asked to answer the questions on the Corah Dental Anxiety Scale on behalf of their children to assess their dental anxiety, and the results were scored. The children's heart rate was then measured and recorded using a pulse oximeter attached to the index finger of the left hand. Patients in the video group then watched an animated video entitled 'First meeting with the dentist' before the examination, and dental instruments were introduced using the terminology mentioned in the video. Using behavioural techniques, the patients were examined and their anxiety levels were assessed using the same methods after the examination.

Behavioral: watching video

Tell-show-do group

OTHER

Before the examination, the child was asked to choose one of five faces on the Facial Image Scale (FIS). The dentist assessed and scored the patient's behaviour using the Frankl Behaviour Scale. Parents were asked to complete the Corah Dental Anxiety Scale on behalf of their children to assess their dental anxiety, and the results were scored. The children's heart rate was then measured and recorded using a pulse oximeter attached to the index finger of the left hand. Following the application of the behavioural techniques, the patients were examined and their anxiety levels were assessed using the same methods after the examination procedure.

Behavioral: tell-show-do group

Interventions

playing mobile gameBEHAVIORAL

Changes in anxiety levels were measured by playing a mobile game to children before dental examination.

Play group
reading bookBEHAVIORAL

Changes in anxiety levels were measured by reading books to children before dental examination.

Book group
watching videoBEHAVIORAL

Changes in anxiety levels were measured by showing a video to children before dental examination.

Video group
tell-show-do groupBEHAVIORAL

Before the dental examination, the tell-show-do technique was applied to the children and the changes in their anxiety levels were measured.

Tell-show-do group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • The child must be between 3-6 years old
  • No previous dentist experience
  • No systemic disease or syndrome

You may not qualify if:

  • The child is under 3 years old and over 6 years old
  • Having been to the dentist before for an examination or dental treatment.
  • Having any systemic disease or syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bülent Ecevit Univercity

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

Study Officials

  • gamze kılıç, 1

    Bulent Ecevit University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 17, 2024

First Posted

June 17, 2024

Study Start

January 1, 2022

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

June 17, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)