Dental AnxietyNCT06463067
Books, Videos And Mobile Games İn Pediatric Dentistry
A study testing playing mobile game, reading book and watching video in people with Dental Anxiety and Child, Only, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Child, Only
- What is being tested?
- playing mobile game, reading book and watching video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child must be between 3-6 years old
- No previous dentist experience
- No systemic disease or syndrome
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bülent Ecevit Univercity
Zonguldak, Kozlu, 67600
About this study
Official title: Evaluation Of The Effects Of Reading Educational Books, Showing Videos, And Playing Mobile Games On Dental Anxiety In Children
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:
- Does reading educational books before dental examinations reduce dental anxiety in children?
- Does watching educational videos before dental examinations reduce children's dental anxiety?
- Does playing educational mobile games before dental check-ups reduce dental anxiety in children?
Read the detailed description
ackground: Behaviour management techniques have an important place in paediatric dentistry. However, alternative methods may be needed if they are found to be ineffective in reducing children's dental anxiety.Aim: This study aimed to evaluate the impact of reading educational books, watching videos and playing mobile games from the child's, dentist's and parent's perspective on children's dental anxiety before treatment.
Methods: A total of 160 patients were randomly assigned to four groups. Anxiety levels of patients in each group were assessed using the Facial Image Scale, the Frankl Behaviour Scale and pulse oximetry. The Corah Dental Anxiety Scale was administered to parents to assess their child's anxiety level. The first group was exposed to the tell-show-do technique, the second group read a book, the third group watched a video and the fourth group played a mobile phone game. The children in each group were then assessed. Anxiety levels were then reassessed using the same scales.
- Conditions
- Dental Anxiety, Child, Only
- Being tested
- playing mobile game, reading book, watching video, tell-show-do group
- Keywords
- book, Dental anxiety, Behavior management, video, mobil game
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
playing mobile gameBehavioural
Changes in anxiety levels were measured by playing a mobile game to children before dental examination.
reading bookBehavioural
Changes in anxiety levels were measured by reading books to children before dental examination.
watching videoBehavioural
Changes in anxiety levels were measured by showing a video to children before dental examination.
tell-show-do groupBehavioural
Before the dental examination, the tell-show-do technique was applied to the children and the changes in their anxiety levels were measured.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: tell-show-do group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: after dental examination to 10 minute
Secondary outcomes (1)
child's anxiety level according to the researcher
We evaluated the effects of reading informative books, playing mobile games and watching videos after the dental examination on dental anxiety by measuring the Frankl Behaviour Scale, (Frankl Behavior Scale: is based on the observation, evaluation and scoring of the child's behavior by the dentist. In this scale, which is filled in by the dentist, the child's behavior in different situations is classified as strongly negative (1), negative (2), positive (3), strongly positive (4). )
Measured: after dental examination to 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jan 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melek Belevcikli, Bulent Ecevit University
- Investigators
- gamze kılıç, 1, Principal investigator, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463067
- Sponsor's protocol ID
- Bülent Ecevit Üniversitesi
- Status last verified
- Jun 2024
- First submitted
- 17 May 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Effects Of Reading Educational Books, Showing Videos, And Playing Mobile Games On Dental Anxiety In Children
- ClinicalTrials.gov ID
- NCT06463067
- Acronym / sponsor ID
- Bülent Ecevit Üniversitesi
- Conditions
- Dental Anxiety, Child, Only
- Keywords
- book, Dental anxiety, Behavior management, video, mobil game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does reading educational books before dental examinations reduce dental anxiety in children?
- Does watching educational videos before dental examinations reduce children's dental anxiety?
- Does playing educational mobile games before dental check-ups reduce dental anxiety in children?
Detailed description
ackground: Behaviour management techniques have an important place in paediatric dentistry. However, alternative methods may be needed if they are found to be ineffective in reducing children's dental anxiety.Aim: This study aimed to evaluate the impact of reading educational books, watching videos and playing mobile games from the child's, dentist's and parent's perspective on children's dental anxiety before treatment.
Methods: A total of 160 patients were randomly assigned to four groups. Anxiety levels of patients in each group were assessed using the Facial Image Scale, the Frankl Behaviour Scale and pulse oximetry. The Corah Dental Anxiety Scale was administered to parents to assess their child's anxiety level. The first group was exposed to the tell-show-do technique, the second group read a book, the third group watched a video and the fourth group played a mobile phone game. The children in each group were then assessed. Anxiety levels were then reassessed using the same scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Play group | Other | Behavioral: playing mobile gameBefore 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 |
| Book group | Other | Behavioral: reading bookBefore 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. |
| Video group | Other | Behavioral: watching videoBefore 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. |
| Tell-show-do group | Other | Behavioral: tell-show-do groupBefore 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The child must be between 3-6 years old
- No previous dentist experience
- No systemic disease or syndrome
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| playing mobile gameChanges in anxiety levels were measured by playing a mobile game to children before dental examination. | Behavioural | Play group |
| reading bookChanges in anxiety levels were measured by reading books to children before dental examination. | Behavioural | Book group |
| watching videoChanges in anxiety levels were measured by showing a video to children before dental examination. | Behavioural | Video group |
| tell-show-do groupBefore the dental examination, the tell-show-do technique was applied to the children and the changes in their anxiety levels were measured. | Behavioural | Tell-show-do group |
Primary outcome
anxiety level according to the child
Time frame: after dental examination to 10 minute
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.)
1 secondary outcome
child's anxiety level according to the researcher
Time frame: after dental examination to 30 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
gamze kılıç, 1 principal investigator
Bulent Ecevit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing playing mobile game, reading book and watching video in people with Dental Anxiety and Child, Only, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety level according to the child (time frame: after dental examination to 10 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.