Kaleidoscope Compared to Tell-Show-Do for Reducing Children Pain and Anxiety During Pulp Therapy

Официальное название

Comparative Evaluation of Kaleidoscope Versus Tell-Show Do in Management of Dental Pain and Anxiety In Children Undergoing Pulp Therapy: A Randomized Clinical Trial

Обзор

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.

Вмешательства

• Поведенческое behavior management using Kaleidoscope glasses (SOL, country of origin: China).
  behavior management using Kaleidoscope glasses (SOL, country of origin: China).
• Поведенческое behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China).
  behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China).
• Поведенческое behavior management using the Tell-Show-Do technique.
  behavior management using the Tell-Show-Do technique.

Первичные конечные точки

• Assessment of pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale [Срок оценки: Child's pain level will be assessed during Local anesthesia injection and pulpotomy by using the FLACC scale.]

Вторичные конечные точки (2)

• Assessment of dental anxiety [Срок оценки: 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) [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Children with systemic or mental disorders.
• Children without parental consent.
• Children complaining of acute dental pain.
• Children receiving analgesics within the last 48 hours.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07595731 · KDvsTSD-PAIN-CH-PULP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗