Kaleidoscope Compared to Tell-Show-Do for Reducing Children Pain and Anxiety During Pulp Therapy
Comparative Evaluation of Kaleidoscope Versus Tell-Show Do in Management of Dental Pain and Anxiety In Children Undergoing Pulp Therapy: A Randomized Clinical Trial
The goal of this clinical trial is to investigate if Kaleidoscope glasses help children feel less pain and worry during dental work. It will also explore if these glasses help children feel more comfortable with the dentist.
Kaleidoscope glasses are special glasses show bright, colorful shapes. The patterns change every time the child moves their head. This helps keep the child's mind off the dental work.
The main questions it aims to answer are:
Do the glasses lower a child's pain during a numbing shot and tooth treatment?
Do the glasses help a child feel less anxious during the visit?
Researchers will compare the glasses to a method called "Tell-Show-Do" to see which works best. "Tell-Show-Do" is when a dentist explains and shows tools before using them.
Participants will:
Get a nerve treatment (a "baby root canal") on a bottom baby tooth.
Wear the Kaleidoscope glasses, have the researcher use "Tell-Show-Do," or do both.
Have their pulse and pain levels checked before, during, and after the visit.
To keep the study fair, the child will be put into 1 of 3 groups by picking a sealed random envelope.
The groups are:
Group 1: The child wears Kaleidoscope glasses (the special glasses).
Group 2: The child wears Kaleidoscope glasses and the operator uses the "Tell-Show-Do" method during the visit with the child.
Group 3: The operator uses the "Tell-Show-Do" method during the visit with the child only.
This study helps make the dental visit easier and more comfortable for children. It aims to:
Lower pain during the tooth treatment. Help children feel less afraid of the dentist. Make children more willing to get the care they need. The research also helps dentists give better care by building trust with their young participants.
Risks:
There are no serious risks in this study. In rare cases, a child may not want to wear the special glasses. If this happens, the researcher will stop using the glasses but will still finish the tooth treatment.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Nada M. Abdelaziz, Bachelor degree
- 電話番号：+201005171751
- メール：nada.mosaad@dentistry.cu.edu.eg
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Children aged between 4-6 years old.
- Healthy with no systemic illness or allergies.
- Indicated for pulp therapy in their lower primary molar.
- Parents who agree to sign informed consent.
Exclusion Criteria:
- Children with systemic or mental disorders.
- Children without parental consent.
- Children complaining of acute dental pain.
- Children receiving analgesics within the last 48 hours.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Behavior management using the Tell-Show-Do technique during the treatment.
|
behavior management using the Tell-Show-Do technique.
他の名前：
|
|
実験的：behavior management using Kaleidoscope glasses.
behavior management while the child is wearing Kaleidoscope glasses (SOL, country of origin: China) during the treatment.
|
behavior management using Kaleidoscope glasses (SOL, country of origin: China).
他の名前：
|
|
実験的：behavior management using the Tell-Show-Do technique and Kaleidoscope glasses
behavior management using the Tell-Show-Do technique and while the child is wearing Kaleidoscope glasses (SOL, country of origin: China).
|
behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China).
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assessment of pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale
時間枠：Child's pain level will be assessed during Local anesthesia injection and pulpotomy by using the FLACC scale.
|
Assessment of pain using the FLACC scale: (Quantitative outcome) 0-10 score with 0 representing no pain and better outcome and data will be collected directly from participants.
|
Child's pain level will be assessed during Local anesthesia injection and pulpotomy by using the FLACC scale.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assessment of dental anxiety
時間枠：Child's anxiety level will be collected using a Pulse oximeter before behaviour management, pre-operatively after behaviour management, and within 5 minutes postoperatively.
|
Assessment of dental anxiety using finger Pulse oximeter (Quantitative outcome) scores(beats/min)
|
Child's anxiety level will be collected using a Pulse oximeter before behaviour management, pre-operatively after behaviour management, and within 5 minutes postoperatively.
|
|
Assessment of dental anxiety using Facial Image Scale (FIS)
時間枠：Child's anxiety level will be collected using a facial image scale before behaviour management, pre-operatively after behaviour management, and within 5 minutes postoperatively.
|
Assessment of dental anxiety using Facial Image Scale (FIS): (Quantitative outcome) Image scores (1-5) with 1 (most positive child experience and best outcome) and 5 (most negative and worst outcome).
|
Child's anxiety level will be collected using a facial image scale before behaviour management, pre-operatively after behaviour management, and within 5 minutes postoperatively.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- KDvsTSD-PAIN-CH-PULP
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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