小児の不安と歯科処置の局所麻酔中の行動に対するセラピー犬の影響
局所麻酔中の小児歯科患者の不安と行動に対するセラピー犬の影響：ランダム化比較試験
Therapy dogs in dental offices might help anxious children during dental care. Therapy dogs might help children during injection of local anesthetic, when we inject numbing medication before working on the teeth. The goal of this study is to learn if having a therapy dog with a child during the injection of numbing medication helps children to be more comfortable at the dentist's office. This study is of children who need dental care using local anesthesia. Study participant's behavioral reactions and heart rate during injection of local anesthetic with and without having a therapy dog present will be recorded and children and their guardians will be asked a few short questions about the injection and therapy dog after injection.
調査の概要
詳細な説明
Children undergoing dental restorative or surgical procedures require injection of local anesthetic. The injection procedure is often the most anxiety-producing stimulus for children during dental care, when children demonstrate the highest level of emotional distress. Several studies have investigated various interventions, such as distraction, hypnosis, and cognitive behavioral therapy to ease this stress. Animal-assisted therapy (e.g. the presence of a therapy dog) may be a promising strategy for managing anxiety in young dental patients. However, no studies have explored the potential benefits of using therapy dogs specifically during the administration of local anesthesia in pediatric dental patients. The objective of this randomized controlled trial is to investigate the effects of therapy dogs on pediatric dental patients during local anesthesia administration.
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：James R Boynton, DDS, MS
- 電話番号：734-764-1523
- メール：jboynton@umich.edu
研究場所
-
-
Michigan
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Ann Arbor、Michigan、アメリカ、48109
- 募集
- University of Michigan School of Dentistry Children's Clinic
-
コンタクト：
- James R Boynton, DDS, MS
- 電話番号：734-764-1523
- メール：jboynton@umich.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age range: children aged 4- to 12-years
- Health status: healthy children without significant medical conditions (ASA I or ASA II)
- Dental procedure: children scheduled for at least two dental procedures requiring local anesthesia
- Consent: written informed consent from the parent or legal guardian
- Verbal assent from potential subjects age 4-9 years; written assent for children age 10-12 years
Exclusion Criteria:
- Allergies: children with known allergies to dogs or animal dander
- Children with a fear or phobia of dogs
- Children with a behavioral disorder which may negatively impact response to the presence of a therapy dog
- Previous exposure: children who have previously undergone dental procedures with local anesthesia in the presence of a therapy dog
- Medical conditions: children with medical conditions that might affect their vital signs independently of the dental procedure (e.g., heart conditions)
- Parental discomfort: cases where parents are uncomfortable with the presence of a therapy dog during the procedure
- Advanced behavior guidance is indicated: children whose behavior for dental examination is classified as "Definitely Negative" (Frankl 1)
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：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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：Control
Standard-of-care basic behavior guidance during local anesthesia |
Basic behavior guidance as defined by the American Academy of Pediatric Dentistry includes strategies to help children cope through potentially stressful dental procedures. These strategies include tell-show-do, positive reinforcement, parental presence, and nitrous oxide/oxygen analgesia, among others. |
|
実験的：Therapy dog presence
Therapy dog present during local anesthesia administration |
A trained therapy dog will be present during the child's dental appointment. The dog will be in the operatory as the child enters the room and will lie on the child during injection of local anesthesia. |
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 |
|---|---|---|
|
Behavior (Face, Legs, Activity, Cry, and Consolability scale)
時間枠：Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia
|
The subject's behavior from entry into the operatory through one minute following administration of local anesthesia will be evaluated and recorded using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale, with each category scored from 0 to 2. The higher the total score, which ranges from 0 to 10, indicates more distress. |
Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Heart rate
時間枠：Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia
|
The subject's heart rate will be monitored and recorded every 30 seconds from entry into the operatory through one minute following administration of local anesthesia. |
Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia
|
|
Anxiety assessment (Modified Faces version of the Modified Child Dental Anxiety scale)
時間枠：Upon entering the operatory and after administration of local anesthesia
|
The subject will be asked to complete an anxiety assessment using the revised modified faces version of the modified child dental anxiety scale (MCDASF). This questionnaire has two questions which are each answered on a five-point scale (range 1-5 for each question for a total range of 2-10). Higher values represent more distress. |
Upon entering the operatory and after administration of local anesthesia
|
|
Parent questionnaire
時間枠：Following injection of local anesthetic
|
The subject's parent will be asked four questions regarding their child's anxiety and the therapy dog (if present). These four questions are not scaled. The questions are: Do you think your child was anxious for local anesthesia? Y/N; Do you think the therapy dog reduced your child's dental anxiety during local anesthesia? Yes/No; Would you want a therapy dog present for future dental treatment appointments? Yes/No; How do you think your child fees post-local anesthesia? Very Anxious/Anxious/Neutral/Calm/Very Calm. |
Following injection of local anesthetic
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：James R. Boynton, DDS, MS、University of Michigan
研究記録日
主要日程の研究
研究開始 (実際)
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
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