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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06241157
Other study ID # MU_SD_DPD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 21, 2022
Est. completion date July 1, 2024

Study information

Verified date February 2024
Source Marmara University
Contact Ozge Koyuncu, Dentist
Phone 0090-5342243836
Email ozge.koyuncu@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Behavior orientation is the cornerstone of the success of pediatric dentistry. The use of behavior management techniques enables children to learn appropriate behavior and coping skills, reduce anxiety, and facilitate the delivery of adequate oral health care. Some behavior guidance systems have been tried to be created. On the basis of the magic game, it has been tried to move the children away from the current real situation, the reality of dental treatment, to move forward in communication and successful results have been obtained. The main thing in the technique is to start the communication with the child in the waiting room of the dentist and to reduce the anxiety of the child by improving the self-efficacy perception of the child. The aim of this study is to investigate the effectiveness of question-answer behavior guidance technique in dental treatment in pediatric patients.


Description:

Behavior orientation is the cornerstone of the success of pediatric dentistry. The use of behavior management techniques enables children to learn appropriate behavior and coping skills, reduce anxiety, and facilitate the delivery of adequate oral health care. Better communication can be achieved when children feel the freedom to express themselves. In the same way, parents may state that in cases where there is no coercion and verbal communication, the children are uncomfortable and they have problems during their second-third dentist visits. However, in some cases, success may not be achieved even if different behavior management techniques are applied. Activities such as diverting attention in children to other areas, starting the communication in the waiting room before entering the practice environment can lead to self-confidence, relaxation and confidence. The method of rewarding can also be very effective in directing behavior in children. For this reason, it communicates with a combination of some techniques without depending on only one technique and can lead to applications in dentistry practice. Based on this idea, some behavior guidance systems have been tried to be created. On the basis of the magic game, it has been tried to move the children away from the current real situation, the reality of dental treatment, to move forward in communication and successful results have been obtained. With this information, the aim of our study is to experience a new behavior management technique in children. The main thing in the technique is to start the communication with the child in the waiting room of the dentist and to reduce the anxiety of the child by improving the self-efficacy perception of the child. In this direction, in order to increase the child's self-efficacy perception, simple questions are asked to the child about colors, fruits and animals, if necessary, clues are given to give correct answers, and verbal praise for correct answers aims to increase self-efficacy perception and reduce anxiety. After the communication is started in the waiting room, the dental examination, dental chair and planned procedures will be introduced to the child, together with the tell-show-do method, as always practiced in the dental chair. The aim of this study is to investigate the effectiveness of question-answer behavior guidance technique in dental treatment in pediatric patients. Children's pain and anxiety levels were assessed by various tests designed to purpose. The Visual Analogue Scale (VAS), a self-reporting scale,was preferred to evaluate children's experience of pain. The scale displayed a colored spectrum on the front side ranging from no pain (white) to severe pain (red), which indicates relevant pain scores ranging from 0 to 10 on the reverse side.10


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date July 1, 2024
Est. primary completion date April 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 8 Years
Eligibility Inclusion Criteria: 1. Children of age group 4-8 years. 2. with no previous dental experience. 3. without any systemic or mental disorders. Exclusion Criteria: 1. Children or their families that could not agree to participate the study 2. They had a previous serious dental experience in need of emergency treatment 3. Having systemic or mental disorders

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pediatric Quiz Game
Investigator will start interacting with children upon their arrival and during their presence in the waiting room before entering the operating room. This will help to obtain better cooperation (frankl scale) and anxiety reductions (FIS and VPT) at different stages of the dental examination (e.g., entering the clinic, sitting on the dental chair, opening mouth, examination with mirror, probe, use of low-high-speed handpieces, ITR restoration). Pediatric Quiz is actually an ice-breaking quiz game developed for children, with the promise of a surprise gift at the end. It can be defined as "asking children basic questions on colors, animals, fruits and/or cities depending on the age of the child among which the child would choose him/herself and answer the question easily.

Locations

Country Name City State
Turkey Marmara University, Faculty of Dentistry, Department of Pediatric Dentistry Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Grisolia BM, Dos Santos APP, Dhyppolito IM, Buchanan H, Hill K, Oliveira BH. Prevalence of dental anxiety in children and adolescents globally: A systematic review with meta-analyses. Int J Paediatr Dent. 2021 Mar;31(2):168-183. doi: 10.1111/ipd.12712. Ep — View Citation

Peretz B, Gluck G. Magic trick: a behavioural strategy for the management of strong-willed children. Int J Paediatr Dent. 2005 Nov;15(6):429-36. doi: 10.1111/j.1365-263X.2005.00668.x. — View Citation

Shahnavaz S, Hedman-Lagerlof E, Hasselblad T, Reuterskiold L, Kaldo V, Dahllof G. Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Dental Anxiety: Open Trial. J Med Internet Res. 2018 Jan 22;20(1):e12. doi: 10.2196/jmir.7803. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The Visual Analogue Scale (VAS) Participants' pain and anxiety levels were assessed. The scale displayed a colored spectrum on the front side ranging from no pain (white) to severe pain (red), which indicates relevant pain scores ranging from 0 to 10 on the reverse side. 3 Months
Primary The Dental Subscale of Children's Fear Survey Schedule parental version (CFSS-DS pv) The Scale consists of 15 articles. The answers are given by parents on a Likert type scale, ranging from 15 to 75. For children with moderate and severe dental fear levels, threshold values are set as 32 and 38 points, respectively. 3 months
Primary The Venham Picture Test (VPT), a self-reporting scale The scale is used to evaluate children's situational anxiety. It consists of 16 illustrations in pairs.Among the pairs, one represents the presence of anxiety and the other represents absence of anxiety. Children's anxiety scores were calculated between 0 and 8, according to the illustration they chose, representing themselves. Higher scores indicate the presence of anxiety and its level. 3 months
Primary Facial Image Scale (FIS). Self-report scale will be used in the study to evaluate children's state of anxiety. It displays nine faces showing emotions ranging from "non-anxious" to "very anxious." Participants are requested to indicate the face that represents their actual feelings. The scores range between 0.04 (positive/nonanxious) and 0.97 (negative/very anxious), demonstrating the state anxiety. 3 months
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