- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07632547
Video-Enhanced Tell-Show-Do for Managing Dental Anxiety in Children
Reinforcing the Tell-Show-Do Technique With a Simulated Real-mouth Video to Manage Dental Anxiety in Children During Dental Treatment (A Randomized Controlled Trial)
연구 개요
상세 설명
Dental fear and anxiety in children are associated with several visual stimuli, such as the shape of the dental handpiece or saliva ejector, as well as painful procedures like local anaesthesia, which may create a barrier to receiving dental treatment. Many studies have explored various behaviour management techniques to reduce anxiety during treatment; however, few have investigated the effect of using a video simulation of the real oral environment to familiarise children with treatment steps and reinforce the phrases commonly used by the dentist. This study was designed to reassure children by using a video that demonstrates carious lesions and dental instruments, including the mirror, saliva ejector, handpiece, and syringe, and shows how they work inside the mouth in a child-friendly manner.
This research is a randomised controlled clinical trial in which participants were assigned to two groups based on the behaviour management technique used. Anxiety was assessed using three integrated measures: a self-reported anxiety scale, an observer-rated behaviour scale, and physiological indicators including oxygen saturation and heart rate. All measures were recorded before, during, and after treatment to provide a comprehensive evaluation of the intervention's effect on children's anxiety levels.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Rana Soleman
- 전화번호: +963 934 966 599
- 이메일: drranasoliman66@gmail.com
연구 장소
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Damascus, 시리아
- 모병
- Damascus University
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연락하다:
- Rana Soliman
- 전화번호: +963 934 966 599drranasoliman6
- 이메일: drranasoliman66@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Children aged 4-6 years, with or without previous dental experience.
- Children with a positive behavior rating according to the Frankl scale.
- Children with primary molars requiring conservative dental treatment.
Exclusion Criteria:
- Children with systemic or mental disorders.
- Children who received sedative or analgesic medications within the 3 hours prior to the dental visit.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Tell-Show-Do behavior management technique
Children in this group will receive restorative treatment with following the traditional TSD technique without any visual aids.
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This group received treatment guided by the Tell-Show-Do (TSD) method.
Each step was explained through simple analogies-referring to local anesthesia as 'sleepy juice' and the rubber dam as a 'trap' for the 'tooth worm.'
After the explanation and instrument demonstration, restorative treatment was carried out.
The protocol excluded the use of any audiovisual aids.
All procedures involved conservative restoration of the mandibular primary molars
다른 이름들:
Children in this group were managed using a video-assisted Tell-Show-Do (VATSD) approach incorporating real-oral simulation.
Each procedural step was preceded by a specific segment of a pre-recorded video tailored to the upcoming task.
The video featured a simulated intraoral environment where dental caries was personified by an animated 'tooth worm' to explain decay and its removal.
Consistent with conventional TSD, the video integrated child-friendly analogies: local anesthesia was introduced as 'sleepy juice'-depicting the 'tooth worm' falling asleep-and the rubber dam was shown as a barrier to prevent its escape.
These segments sequentially covered examination, anesthesia, rubber dam placement, and cavity preparation.
Each viewing was followed by a standardized verbal explanation before performing the clinical procedure.
All participants underwent conservative restorative treatment of the mandibular primary molars
다른 이름들:
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실험적: Real-Oral Simulation Video-Assisted Tell-Show-Do Technique
Children in this group will receive restorative treatment with following the enhanced Tell-Show-Do technique with a video simulating the real oral environment
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This group received treatment guided by the Tell-Show-Do (TSD) method.
Each step was explained through simple analogies-referring to local anesthesia as 'sleepy juice' and the rubber dam as a 'trap' for the 'tooth worm.'
After the explanation and instrument demonstration, restorative treatment was carried out.
The protocol excluded the use of any audiovisual aids.
All procedures involved conservative restoration of the mandibular primary molars
다른 이름들:
Children in this group were managed using a video-assisted Tell-Show-Do (VATSD) approach incorporating real-oral simulation.
Each procedural step was preceded by a specific segment of a pre-recorded video tailored to the upcoming task.
The video featured a simulated intraoral environment where dental caries was personified by an animated 'tooth worm' to explain decay and its removal.
Consistent with conventional TSD, the video integrated child-friendly analogies: local anesthesia was introduced as 'sleepy juice'-depicting the 'tooth worm' falling asleep-and the rubber dam was shown as a barrier to prevent its escape.
These segments sequentially covered examination, anesthesia, rubber dam placement, and cavity preparation.
Each viewing was followed by a standardized verbal explanation before performing the clinical procedure.
All participants underwent conservative restorative treatment of the mandibular primary molars
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Heart Rate
기간: during a single dental treatment visit at baseline before treatment, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during restorative treatment.
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Assessment tool: Pulse oximeter Measurement unit: Beats per minute (bpm) Assessment time points: Heart rate was assessed during a single dental treatment visit at baseline before treatment, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during restorative treatment. |
during a single dental treatment visit at baseline before treatment, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during restorative treatment.
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Facial Image Scale (FIS)
기간: The Facial Image Scale was assessed during a single dental treatment visit at baseline (first visit before intervention) and during dental treatment.
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Assessment tool: Facial Image Scale questionnaire Measurement unit: Ordinal score (1-5) Assessment time points: Facial Image Scale was assessed during a single dental treatment visit at baseline and during treatment. |
The Facial Image Scale was assessed during a single dental treatment visit at baseline (first visit before intervention) and during dental treatment.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Oxygen Saturation (SpO₂)
기간: Baseline; after behavior management; during injection; before rubber dam placement; during rubber dam placement; before handpiece use; during treatment during a single dental treatment visit.
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Assessment tool: Pulse oximeter Measurement unit: Percentage (%) Assessment time points: Oxygen saturation was measured using a pulse oximeter and recorded during a single dental treatment visit at baseline, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during dental treatment. |
Baseline; after behavior management; during injection; before rubber dam placement; during rubber dam placement; before handpiece use; during treatment during a single dental treatment visit.
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공동 작업자 및 조사자
수사관
- 연구 책임자: Chaza Kouchaji, Damascus University
간행물 및 유용한 링크
일반 간행물
- Liu Y, Gu Z, Wang Y, Wu Q, Chen V, Xu X, Zhou X. Effect of audiovisual distraction on the management of dental anxiety in children: A systematic review. Int J Paediatr Dent. 2019 Jan;29(1):14-21. doi: 10.1111/ipd.12430. Epub 2018 Oct 26.
- Abbasi H, Saqib M, Jouhar R, Lal A, Ahmed N, Ahmed MA, Alam MK. The Efficacy of Little Lovely Dentist, Dental Song, and Tell-Show-Do Techniques in Alleviating Dental Anxiety in Paediatric Patients: A Clinical Trial. Biomed Res Int. 2021 May 23;2021:1119710. doi: 10.1155/2021/1119710. eCollection 2021.
- Khandelwal D, Kalra N, Tyagi R, Khatri A, Gupta K. Control of Anxiety in Pediatric Patients using "Tell Show Do" Method and Audiovisual Distraction. J Contemp Dent Pract. 2018 Sep 1;19(9):1058-1064.
- Seligman LD, Hovey JD, Chacon K, Ollendick TH. Dental anxiety: An understudied problem in youth. Clin Psychol Rev. 2017 Jul;55:25-40. doi: 10.1016/j.cpr.2017.04.004. Epub 2017 Apr 19.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UDDS-Pedo-03-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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