Dental FearNCT06142227
The Effect of Reading a Pictorial Storybook on Children's Fear, Anxiety and Emotional Symptoms Before Dental Treatment
A study testing Reading a Pictorial Storybook in people with Dental Fear, run by Gamze Akay at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of reading a picture storybook on children's fear, anxiety and emotional symptoms before dental treatment. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Dental Fear
- What is being tested?
- Reading a Pictorial Storybook
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 30 May 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- No audiovisual impairment,
- Being open to communication and
- Must be accompanied by a parent.
Who cannot join
- Having special needs,
- Having an audio-visual impairment,
- Learning difficulties or mental retardation and
- Children whose parents do not agree to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Artvin Oral and Dental Health Centre
Artvin, 08000
About this study
Official title: The Effect of Reading a Pictorial Storybook on Children's Fear, Anxiety and Emotional Symptoms Before Dental Treatment: A Randomised Controlled Study
The aim of this study was to determine the effect of reading a picture storybook on children's fear, anxiety and emotional symptoms before dental treatment.
Read the detailed description
In children with receiving dental treatment will be randomly divided into two groups: picture storybook group and control. Interventions will be applied for only 1 times. While the illustrated storybook is read to the experimental group, no intervention will be applied to the control group. The children will be assessed before, during and after. Fear, anxiety and emotional symptoms due to dental treatment procedure will be evaluated using the Children's Emotional Indicator Scale, Child Anxiety Scale-Stateness and Children's Fear Scale.
- Conditions
- Dental Fear
- Being tested
- Reading a Pictorial Storybook
- Keywords
- dental fear, Children, dental anxiety, emotional indicators, pictorial storybook
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading a Pictorial StorybookOther
The pictorial storybook by children will be chosen by child psychologists. The book will be read to children by researcher. The researcher has a fairy tale therapy certificate. The pictorial storybook reading will start 15 minutes before the dental treatment process and will be completed before the treatment process begins.. The pictorial storybook will be read to children only one time.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Routine dental treatment will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | Before dental treatment, the child will be read a story book with pictures of the dental clinic. Receives: Other: Reading a Pictorial Storybook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Information Form
It is a form consisting of a total of 13 questions including the child's age, gender, diagnosis, duration of treatment, number of treatments (How many times did the child come to the clinic?), the status of receiving information about dental treatment and the person who received the information, the education level and occupation of the mother and father, the place where the family lives and the economic situation. It was prepared by the researchers in line with the literature.
Measured: baseline
Secondary outcomes (1)
Child anxiety Scale-State
"Child Anxiety Scale-State" scale developed by Ersig et al. in 2013 measures the state anxiety of children aged 4-10 years. In 2017, Gerceker et al. carried out Turkish validity study for the scale. CAS-S (State) is designed as a thermometer. At the bottom is the bulb chamber, and upward are horizontal lines. Each horizontal line represents a score, and the thermometer has 10 points. The bulb chamber at the bottom is 0 points and indicates that there is no anxiety. It is interpreted as the rise of anxiety as it rises upwards. The peak is worth 10 points and refers to the highest anxiety.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental FearStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gamze Akay
- Sponsor type
- University, hospital or other
- Collaborators
- Artvin Coruh University
- Responsible party
- Sponsor-investigator, Gamze Akay, Artvin Coruh University
- Investigators
- Ayşe TAŞTAN, 3, Study chair, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142227
- Sponsor's protocol ID
- Audio book for children
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alsaadoon AM, Sulimany AM, Hamdan HM, Murshid EZ. The Use of a Dental Storybook as a Dental Anxiety Reduction Medium among Pediatric Patients: A Randomized Controlled Clinical Trial. Children (Basel). 2022 Mar 1;9(3):328. doi: 10.3390/children9030328.
PubMed 35327700Aminabadi NA, Vafaei A, Erfanparast L, Oskouei SG, Jamali Z. Impact of pictorial story on pain perception, situational anxiety and behavior in children: a cognitive-behavioral schema. J Clin Pediatr Dent. 2011 Winter;36(2):127-32. doi: 10.17796/jcpd.36.2.3163251527508338.
PubMed 22524072
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reading a Pictorial Storybook on Children's Fear, Anxiety and Emotional Symptoms Before Dental Treatment: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06142227
- Acronym / sponsor ID
- Audio book for children
- Conditions
- Dental Fear
- Keywords
- dental fear, Children, dental anxiety, emotional indicators, pictorial storybook
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gamze AkayUniversity, hospital or other
- Collaborators
- Artvin Coruh University
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 21 Nov 2023 (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 aim of this study was to determine the effect of reading a picture storybook on children's fear, anxiety and emotional symptoms before dental treatment.
Detailed description
In children with receiving dental treatment will be randomly divided into two groups: picture storybook group and control. Interventions will be applied for only 1 times. While the illustrated storybook is read to the experimental group, no intervention will be applied to the control group. The children will be assessed before, during and after. Fear, anxiety and emotional symptoms due to dental treatment procedure will be evaluated using the Children's Emotional Indicator Scale, Child Anxiety Scale-Stateness and Children's Fear Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Routine dental treatment will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | Other: Reading a Pictorial StorybookBefore dental treatment, the child will be read a story book with pictures of the dental clinic. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- No audiovisual impairment,
- Being open to communication and
- Must be accompanied by a parent.
Key exclusion criteria (4 listed)
- Having special needs,
- Having an audio-visual impairment,
- Learning difficulties or mental retardation and
- Children whose parents do not agree to participate in the study.
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 |
|---|---|---|
| Reading a Pictorial StorybookThe pictorial storybook by children will be chosen by child psychologists. The book will be read to children by researcher. The researcher has a fairy tale therapy certificate. The pictorial storybook reading will start 15 minutes before the dental treatment process and will be completed before the treatment process begins.. The pictorial storybook will be read to children only one time. | Other | Experimental Group |
Primary outcome
Demographic Information Form
Time frame: baseline
It is a form consisting of a total of 13 questions including the child's age, gender, diagnosis, duration of treatment, number of treatments (How many times did the child come to the clinic?), the status of receiving information about dental treatment and the person who received the information, the education level and occupation of the mother and father, the place where the family lives and the economic situation. It was prepared by the researchers in line with the literature.
1 secondary outcome
Child anxiety Scale-State
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Results publication: PubMed 35327700Alsaadoon AM, Sulimany AM, Hamdan HM, Murshid EZ. The Use of a Dental Storybook as a Dental Anxiety Reduction Medium among Pediatric Patients: A Randomized Controlled Clinical Trial. Children (Basel). 2022 Mar 1;9(3):328. doi: 10.3390/children9030328.
- Results publication: PubMed 22524072Aminabadi NA, Vafaei A, Erfanparast L, Oskouei SG, Jamali Z. Impact of pictorial story on pain perception, situational anxiety and behavior in children: a cognitive-behavioral schema. J Clin Pediatr Dent. 2011 Winter;36(2):127-32. doi: 10.17796/jcpd.36.2.3163251527508338.
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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.
Ayşe TAŞTAN, 3 study chair
Artvin Coruh 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 Reading a Pictorial Storybook in people with Dental Fear, run by Gamze Akay 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 4 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: status not confirmed, as of the sponsor's last update on 21 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gamze AKAY, 1 ((531) 453 66 61, gamzeakay_25@artvin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic Information Form (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06142227, which also lists 2 linked publications.
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 21 Nov 2023.