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

5. juni 2026 opdateret af: Nada Mosaad Abdel-Aziz, Cairo University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

39

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Behavior management using the Tell-Show-Do technique during the treatment.
Adfærdsmæssigt: behavior management using the Tell-Show-Do technique.
behavior management using the Tell-Show-Do technique.
Andre navne:
  • TSD
  • Tell-Show-Do
  • tell show do
Eksperimentel: behavior management using Kaleidoscope glasses.
behavior management while the child is wearing Kaleidoscope glasses (SOL, country of origin: China) during the treatment.
Adfærdsmæssigt: behavior management using Kaleidoscope glasses (SOL, country of origin: China).
behavior management using Kaleidoscope glasses (SOL, country of origin: China).
Andre navne:
  • Kaleidoscope glasses (SOL, country of origin: China).
  • Kaleidoscope glasses
  • Kaleidoscope distarction
Eksperimentel: 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).
Adfærdsmæssigt: 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).
Andre navne:
  • Kaleidoscope glasses
  • Tell-Show-Do
  • Tell show do

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assessment of pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assessment of dental anxiety
Tidsramme: 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)
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. maj 2027

Datoer for studieregistrering

Først indsendt

6. maj 2026

Først indsendt, der opfyldte QC-kriterier

15. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KDvsTSD-PAIN-CH-PULP

Plan for individuelle deltagerdata (IPD)

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INGEN

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