- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07736170
Effectiveness of Puppet Modeling During Dental Emergency Visits on Dental Anxiety and Behavior of Children in a Subsequent Visit
Effect of Puppet-Aided Tell-Show-Do During Dental Emergency Visit on Dental Anxiety and Behavior of Children in a Subsequent Visit: A Randomized Clinical Trial
The goal of this clinical trial is to learn if using a puppet in dental visits for children is an effective behavior guidance tool. The main questions it aims to answer are:
- Does using a puppet to explain dental procedures to children during emergency dental visits lower their anxiety in a subsequent dental visit?
- Does using a puppet to explain dental procedures to children during emergency dental visits improve their behavior in a subsequent dental visit?
Researchers compared the effect of using a puppet to the traditional tell-show-do behavior guidance technique to see if the puppet is more effective in lowering their anxiety and improving their behavior.
Participants were randomly allocated into two groups:
- Group I: Children who received puppet play therapy in the emergency dental visit and in the subsequent dental visit.
- Group II: Children who received only the traditional tell-show-do behavior guidance technique in the emergency dental visit and in the subsequent dental visit.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Jeddah, 사우디 아라비아
- King Abdulaziz University Dental Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- healthy (including healthy children presenting with a localized dental abscess and no systemic involvement),
- Arabic-speaking
- and required emergency dental treatment under local anesthesia
Exclusion Criteria:
- ASA II or higher according to the American Society of Anesthesiologists Physical Status Classification,
- or if they required advanced behavior guidance, such as protective stabilization, during the emergency visit.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Puppet-aided TSD
Children who received puppet-aided tell-show-do as a behavior guidance technique in the emergency dental visit.
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The investigator used the puppet to interact with the participants and explain the treatment in simple language before starting the dental procedure.
다른 이름들:
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활성 비교기: TSD
Children who received traditional tell-show-do as a behavior guidance technique in the emergency dental visit.
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Tell: The dentist explained what is about to happen using simple, age-appropriate language. Show: The dentist demonstrated the tool outside of the patient's mouth. Do: The dentist performed the procedure in the patient's mouth exactly as described. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Subjective Dental Anxiety as Assessed by Venham Picture Test (VPT) for Children Aged 3-5 Years
기간: 2 weeks after the intervention
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The scale consists of eight pairs of images, each showing a child in both anxious and calm states.
Children are asked to select one image from each pair that best represents how they feel.
Each anxious image chosen is scored as one, while calm selections are scored as zero.
The total dental anxiety score, which ranges from zero to eight, is calculated by summing the individual scores, with higher totals indicating greater anxiety.
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2 weeks after the intervention
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Subjective Dental Anxiety as Assessed by Abeer Children Dental Anxiety Scale (ACDAS) for Children Aged 6-9 Years
기간: 2 weeks after the intervention
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The scale is divided into three sections.
Part A includes 13 self-reported items presented in a logical sequence, in which children indicate their feelings toward different dental situations using three facial expressions: happy/relaxed (score = 1), neutral/ "OK" (score = 2), and scared/anxious (score = 3).
The total score ranges from 13 to 39; scores ≥26 indicate significant dental anxiety.
Part B consists of three yes/no questions exploring the child's cognitive concerns, such as shyness about their teeth or dentist, and fear of losing control during treatment.
Part C gathers additional information from both the parent/guardian and the dentist: parents report on the child's previous dental experiences and anticipated behavior, while the dentist records the child's behavior after treatment.
By combining self-reported, parental, and clinical perspectives, ACDAS provides a comprehensive assessment of dental anxiety in children
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2 weeks after the intervention
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Objective Dental Anxiety as Assessed by the Venham Anxiety Rating Scale (VARS)
기간: 2 weeks after the intervention
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The VARS is constructed of six behaviorally defined categories that range from zero to five, with higher scores indicating higher levels of dental anxiety.
The score gradually increases from relaxed (Score 0), to the child is totally out of control (Score 5).
The target population for this scale is children aged 3-12 years.
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2 weeks after the intervention
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Behavior as Assessed by the Behavior Profile Rating Scale (BPRS)
기간: 2 weeks after the intervention
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An independent observer, other than the operating dentist, is required to systematically record the occurrence of 27 distinct behavioral aspects over a series of 3-minute intervals. Four of these behaviors assess the child's reaction to his separation from a parent. The remaining 23 aspects assess the child's behavior in the dental office. Each behavior is assigned a weighted score that reflects its level of disruptiveness. The total score is calculated by multiplying the frequency of each behavior during the 3-minute periods by its weight, then summing the results across all categories and dividing by the number of intervals. In this study, the BPRS was adapted to be applied once per quadrant during oral prophylaxis, rather than at fixed 3-minute intervals, because the procedure was short and, in some cases, did not extend to three minutes. |
2 weeks after the intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Behavior as Assessed by the Frankl Behavior Rating Scale (FBRS)
기간: immediately after the procedure
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This scale classifies patient behavior into four specific categories.:Definitely
Negative (Rating 1): The child completely refuses treatment, cries forcefully, shows extreme fear, or displays overt negativism.Negative (Rating 2): The child is reluctant to accept treatment and uncooperative, but there is no extreme negativism (e.g., no forceful crying or treatment refusal).Positive (Rating 3): The child accepts treatment and is generally willing to comply with the dentist's directions, though they may be a bit cautious or reserved.Definitely Positive (Rating 4): The child has excellent rapport with the dentist, shows genuine interest in the procedure, laughs, and enjoys the visit.
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immediately after the procedure
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Athanassiadou E, Giannakopoulos G, Kolaitis G, Tsiantis J, Christogiorgos S. Preparing the child facing surgery: The use of play therapy. Psychoanalytic social work. 2012;19(1-2):91-100.
- Khogeer LN, Sabbagh HJ, Felemban OM, Farsi NM. Puppet play therapy in emergency pediatric dental clinic. A randomized clinical trial. BMC Pediatr. 2025 Jul 2;25(1):503. doi: 10.1186/s12887-025-05849-5.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
키워드
기타 연구 ID 번호
- 119-06-23
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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