- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07894744
Virtual Reality and Point-of-View Video Modeling for Dental Anxiety in Children
Comparison of "Virtual Reality" (VR) and "Point-of-View" (POV) Video Modeling Techniques for Reducing Dental Anxiety in Children
Dental anxiety is common among children and may make dental treatment more difficult. This study aims to compare three non-pharmacological behavior guidance techniques for reducing dental anxiety and improving cooperation during invasive fissure sealant treatment in children aged 6-10 years.
Children who require an invasive fissure sealant on a mandibular first molar and meet the study eligibility criteria will be included. Participants will be randomly assigned to one of three groups. The first group will watch a 1.5-2-minute Point-of-View (POV) video showing the dental examination and treatment process from a child's perspective before the dental procedure. The second group will use virtual reality (VR) glasses during the procedure and watch age-appropriate animation or cartoon content as an active distraction technique. The control group will receive the standard Tell-Show-Do behavior guidance technique.
Dental anxiety, behavior, physiological responses, and pain will be assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS), Facial Image Scale (FIS), Frankl Behavior Rating Scale, pulse rate, oxygen saturation, and Wong-Baker FACES Pain Rating Scale. A post-intervention satisfaction and experience questionnaire will also be administered to assess the children's experiences with the behavior guidance techniques.
The study is expected to provide comparative evidence regarding the effectiveness of POV video modeling and VR distraction compared with the standard Tell-Show-Do technique in managing dental anxiety and improving children's cooperation during dental treatment.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
The Facial Image Scale (FIS) will be used to evaluate the child's anxiety at four predefined time points: while the child is waiting in the waiting area, after sitting in the dental unit before the behavior guidance technique, after application of the assigned behavior guidance technique, and after completion of the invasive fissure sealant procedure.
Pulse rate and oxygen saturation will also be recorded at the same four assessment time points using a pulse oximeter. The Frankl Behavior Rating Scale will be used to assess behavioral cooperation before and during the dental procedure. Immediately after completion of the invasive fissure sealant procedure, pain will be assessed using the Wong-Baker FACES Pain Rating Scale. A post-intervention satisfaction and experience questionnaire will also be administered to evaluate the child's experience and perceived comfort with the assigned behavior guidance technique.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Ezgi Demir
- Telefonszám: +905399598979
- E-mail: ezgidemir@gazi.edu.tr
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Didem Atabek, Prof. Dr
- Telefonszám: +903122034080
- E-mail: didemyolalici@gazi.edu.tr
Tanulmányi helyek
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Ankara, Törökország (Türkiye)
- Toborzás
- Gazi University Faculty of Dentistry
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Kapcsolatba lépni:
- Ezgi Demir
- Telefonszám: +905399598979
- E-mail: ezgidemir@gazi.edu.tr
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Kapcsolatba lépni:
- Didem Atabek, Prof. Dr.
- Telefonszám: +903122034080
- E-mail: didemyolalici@gazi.edu.tr
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Children aged 6-10 years.
- Children without any systemic or psychiatric disorder or special needs.
- Children who do not require emergency dental treatment.
- Children whose parent(s) provide written and/or verbal informed consent for participation in the study.
- Children who agree to participate in the assigned intervention, including watching the POV video or using virtual reality (VR) glasses, as applicable.
Exclusion Criteria:
- Children with a systemic or psychiatric disorder or special needs.
- Children who require emergency dental treatment.
- Children who refuse to use virtual reality (VR) glasses.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egyéb
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: POV Video Modeling Group
Participants in this group will watch a 1.5-2-minute Point-of-View (POV) video before the dental procedure. The video presents the dental examination and treatment process from a child's perspective and is designed to familiarize the child with the dental procedure before invasive fissure sealant treatment. |
Participants will watch a 1.5-2-minute Point-of-View (POV) video before the dental procedure. The video presents the dental examination and treatment process from a child's perspective and is intended to familiarize the child with the dental procedure before invasive fissure sealant treatment. |
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Kísérleti: Virtual Reality (VR) Group
Participants in this group will use virtual reality (VR) glasses during the dental procedure. Age-appropriate animation or cartoon content will be presented through the VR glasses as an active distraction technique during invasive fissure sealant treatment. |
Participants will use virtual reality (VR) glasses during the dental procedure. Age-appropriate animation or cartoon content will be presented through the VR glasses as an active distraction technique during invasive fissure sealant treatment. |
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Aktív összehasonlító: Tell-Show-Do Control Group
Participants in this group will receive the standard Tell-Show-Do behavior guidance technique before and during the invasive fissure sealant procedure. The child will be introduced to the dental procedure using the standard Tell-Show-Do approach. |
Participants in the control group will receive the standard Tell-Show-Do behavior guidance technique before and during the invasive fissure sealant procedure. The child will be introduced to the dental procedure using the standard Tell-Show-Do approach. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Facial Image Scale (FIS) Score
Időkeret: Visit 1: Within 1 min after dental examination. Visit 2 (2 weeks later): (1) Before dental examination; (2) within 1 min after seating; (3) within 1 min after behavior guidance; (4) within 1 min after fissure sealant.
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The Facial Image Scale (FIS) is a self-report measure used to assess dental anxiety in children. It consists of five facial images representing increasing levels of anxiety, scored from 1 to 5. A score of 1 indicates the least anxiety, whereas a score of 5 indicates the highest anxiety. Higher scores indicate greater dental anxiety and therefore a worse outcome. FIS scores will be recorded at five time points. During the first visit, the FIS will be administered within 1 minute after completion of the dental examination. During the second visit, which will take place 2 weeks after the initial visit, FIS scores will be recorded at four time points: (1) in the waiting area immediately before the dental examination; (2) within 1 minute after the child is seated in the dental chair; (3) within 1 minute after completion of the assigned behavior guidance technique and before dental treatment; and (4) within 1 minute after completion of the invasive fissure sealant procedure. |
Visit 1: Within 1 min after dental examination. Visit 2 (2 weeks later): (1) Before dental examination; (2) within 1 min after seating; (3) within 1 min after behavior guidance; (4) within 1 min after fissure sealant.
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) Score
Időkeret: Visit 1: Within 5 min after dental examination. Visit 2 (2 weeks later): Within 5 min after fissure sealant procedure.
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Dental fear and anxiety will be assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS), a 15-item scale scored from 15 to 75. Higher scores indicate greater dental fear and anxiety and a worse outcome. Scores are categorized as low (≤32), moderate (33-37), and high (≥38) dental anxiety. CFSS-DS scores will be recorded within 5 minutes after completion of the dental examination during the first visit and within 5 minutes after completion of the fissure sealant procedure during the second visit, which will take place 2 weeks after the initial visit. |
Visit 1: Within 5 min after dental examination. Visit 2 (2 weeks later): Within 5 min after fissure sealant procedure.
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Frankl Behavior Rating Scale Score
Időkeret: Visit 1: During the dental examination. Visit 2: Before the behavior guidance technique: during the dental examination; after the behavior guidance technique: Throughout the fissure sealant procedure, including at treatment completion.
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The child's behavior will be assessed using the Frankl Behavior Rating Scale, which consists of four categories scored from 1 to 4: definitely negative (1), negative (2), positive (3), and definitely positive (4). Higher scores indicate more positive behavior and a better outcome.The child's behavior will be observed during the dental examination at the first visit and, at the second visit, during the dental examination before the behavior guidance technique and throughout the fissure sealant procedure, including at treatment completion. The second visit will take place 2 weeks after the initial visit. |
Visit 1: During the dental examination. Visit 2: Before the behavior guidance technique: during the dental examination; after the behavior guidance technique: Throughout the fissure sealant procedure, including at treatment completion.
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Pulse Rate
Időkeret: Visit 2: (1) In the waiting area, before dental examination; (2) within 1 min after seating in dental unit; (3) within 1 min after behavior guidance, before dental treatment; (4) within 1 min after fissure sealant.
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Pulse rate (beats per minute, bpm) will be measured at four time points during the second visit: (1) in the waiting area immediately before the dental examination; (2) within 1 minute after the child is seated in the dental chair; (3) within 1 minute after completion of the assigned behavior guidance technique and before dental treatment; and (4) within 1 minute after completion of the invasive fissure sealant procedure. |
Visit 2: (1) In the waiting area, before dental examination; (2) within 1 min after seating in dental unit; (3) within 1 min after behavior guidance, before dental treatment; (4) within 1 min after fissure sealant.
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Oxygen Saturation (SpO2)
Időkeret: Visit 2: (1) In the waiting area, before dental examination; (2) within 1 min after seating in dental unit; (3) within 1 min after behavior guidance, before dental treatment; (4) within 1 min after fissure sealant.
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Oxygen saturation (SpO₂), expressed as a percentage (%), will be measured at four time points during the second visit: (1) in the waiting area immediately before the dental examination; (2) within 1 minute after the child is seated in the dental chair; (3) within 1 minute after completion of the assigned behavior guidance technique and before dental treatment; and (4) within 1 minute after completion of the invasive fissure sealant procedure. Changes in SpO₂ will be evaluated across these time points. |
Visit 2: (1) In the waiting area, before dental examination; (2) within 1 min after seating in dental unit; (3) within 1 min after behavior guidance, before dental treatment; (4) within 1 min after fissure sealant.
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Wong-Baker FACES Pain Rating Scale Score
Időkeret: Visit 2: Within 1 min after completion of the fissure sealant procedure.
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Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale, scored from 0 to 10 in increments of 2 (0, 2, 4, 6, 8, and 10). A score of 0 indicates no pain, while 10 indicates the worst pain. Higher scores indicate greater pain intensity and a worse outcome. Pain will be assessed within 1 minute after completion of the invasive fissure sealant procedure during the second visit. |
Visit 2: Within 1 min after completion of the fissure sealant procedure.
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Satisfaction and Experience Questionnaire
Időkeret: Visit 2: Within 5 min after completion of the fissure sealant procedure (POV and VR groups only).
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A post-intervention Satisfaction and Experience Questionnaire will be administered to participants in the POV Video Modeling and Virtual Reality (VR) groups within 5 minutes after completion of the fissure sealant procedure to assess their satisfaction, perceptions, and comfort regarding the assigned behavior guidance technique. Items will be answered with "Yes" or "No." |
Visit 2: Within 5 min after completion of the fissure sealant procedure (POV and VR groups only).
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Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Didem Atabek, Prof. Dr., Gazi University
Publikációk és hasznos linkek
Általános kiadványok
- Kasimoglu Y, Alpaycetin E, Ince G, Tuna Ince EB. Reduction of Dental Anxiety in Children Using Virtual Reality: A Randomised Controlled Trial. Eur J Paediatr Dent. 2025 Sep 1;26(3):185-191. doi: 10.23804/ejpd.2024.2109. Epub 2024 Oct 1.
- Biradar NV, Patil SK, Pustake BJ, Kothawade DS. A Comparative Evaluation of Three Different Modeling Videos on Dental Anxiety of 3-6-year-old Children Requiring Treatment under Local Anesthesia: A Parallel, Randomized Controlled Trial. Int J Clin Pediatr Dent. 2024 Dec;17(12):1357-1362. doi: 10.5005/jp-journals-10005-3016.
- Hine JF, Hajek RT, Roberts HJ, Allen KD. Decreasing disruptive behaviour during routine dental visits: a video modelling intervention for young children. Int Dent J. 2019 Aug;69(4):265-272. doi: 10.1111/idj.12457. Epub 2018 Nov 29.
- Anaturk S, Ozkan HD, Saral IP, Cakar T. Determining the Effect of Video Information on the Dental Anxiety Levels of the Endodontic Patients: A Randomised Clinical Trial. J Oral Rehabil. 2025 Nov;52(11):1933-1944. doi: 10.1111/joor.14054. Epub 2025 Jun 12.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
Egyéb vizsgálati azonosító számok
- 2025-2098
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
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