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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06142227
Other study ID # Audio book for children
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date May 30, 2024

Study information

Verified date November 2023
Source Artvin Coruh University
Contact Gamze AKAY, 1
Phone (531) 453 66 61
Email gamzeakay_25@artvin.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date May 30, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 10 Years
Eligibility Inclusion Criteria: - No audiovisual impairment, - Being open to communication and - Must be accompanied by a parent. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Reading a Pictorial Storybook
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.

Locations

Country Name City State
Turkey Artvin Oral and Dental Health Centre Artvin

Sponsors (2)

Lead Sponsor Collaborator
Gamze Akay Artvin Coruh University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

Aminabadi 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Child Fear Scale This scale was developed by McMurtry et al. in 2011. In 2018, Gerceker et al. carried out a Turkish validity study for the scale. The scale is aimed at children aged 5-10 years. The facial muscle changes in fearful expressions are drawn by a graphic artist based on photos of frightened faces. In this scale, the child is shown a scale containing five facial expressions that are evaluated between 0 and 4 points. While 0 point refers to no fear; 4 points refers to the highest fear. baseline
Other The Children's Emotional Indicator Scale The Children's Emotional Indicator Scale (CEAS) was developed by Li and Lopez and its Turkish validity and reliability was conducted by Çimke and Bayat. The scale consists of five categories of observable emotional behaviours (Facial expression, Vocalization, Activity, Interaction, and Level of cooperation). Each category has a value between 1-5. The total score that can be obtained from the scale varies between 5-25. The higher the scores obtained from the scale, the higher the negative emotional indicators. Cronbach's alpha value of the scale was 0.92. In the Turkish validity and reliability study of the scale, Cronbach's alpha value was determined as 0.94. baseline
Primary 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. baseline
Secondary 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. baseline
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