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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nada M. Abdelaziz, Bachelor degree
- Número de teléfono: +201005171751
- Correo electrónico: nada.mosaad@dentistry.cu.edu.eg
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Behavior management using the Tell-Show-Do technique during the treatment.
|
behavior management using the Tell-Show-Do technique.
Otros nombres:
|
|
Experimental: 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).
Otros nombres:
|
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Experimental: 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).
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behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China).
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assessment of pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Periodo de tiempo: Child's pain level will be assessed during Local anesthesia injection and pulpotomy by using the FLACC scale.
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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.
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Child's pain level will be assessed during Local anesthesia injection and pulpotomy by using the FLACC scale.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assessment of dental anxiety
Periodo de tiempo: 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)
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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)
Periodo de tiempo: 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.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades Estomatognáticas
- Enfermedades de los dientes
- Dolor facial
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor de muelas
- Químicos orgánicos
- Ácidos, acíclico
- Ácidos carboxílicos
- Acrilatos
- Polímeros
- Sustancias macromoleculares
- Materiales biomédicos y dentales
- Materiales manufacturados
- Tecnología, industria y agricultura
- Plástica
- Resinas, sintéticas
- Methylmethacrylates
- Polymethacrylic Acids
- Acrylic Resins
- Metacrilato de polimetilo
Otros números de identificación del estudio
- KDvsTSD-PAIN-CH-PULP
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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