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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Nada M. Abdelaziz, Bachelor degree
- Numero di telefono: +201005171751
- Email: nada.mosaad@dentistry.cu.edu.eg
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Behavior management using the Tell-Show-Do technique during the treatment.
|
behavior management using the Tell-Show-Do technique.
Altri nomi:
|
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Sperimentale: 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).
Altri nomi:
|
|
Sperimentale: 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).
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Assessment of pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Assessment of dental anxiety
Lasso di tempo: Child's anxiety level will be collected using a Pulse oximeter before behaviour management, pre-operatively after behaviour management, and within 5 minutes postoperatively.
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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)
Lasso di tempo: 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.
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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).
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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.
|
Collaboratori e investigatori
Sponsor
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Dolore
- Manifestazioni neurologiche
- Malattie stomatognatiche
- Malattie dei denti
- Dolore facciale
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Mal di denti
- Prodotti chimici organici
- Acidi, aciclici
- Acidi carbossilici
- Acrilati
- Polimeri
- Sostanze macromolecolari
- Materiali biomedici e dentali
- Materiali fabbricati
- Tecnologia, industria e agricoltura
- Plastica
- Resine, sintetiche
- Methylmethacrylates
- Polymethacrylic Acids
- Acrylic Resins
- Polimetilmetacrilato
Altri numeri di identificazione dello studio
- KDvsTSD-PAIN-CH-PULP
Piano per i dati dei singoli partecipanti (IPD)
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