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NCT Number: NCT07595731

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

behavior management using Kaleidoscope glasses (SOL, country of origin: China).

Behavioral

behavior management using Kaleidoscope glasses (SOL, country of origin: China).

Other names: Kaleidoscope glasses (SOL, country of origin: China)., Kaleidoscope glasses, Kaleidoscope distarction

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

Behavioral

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

Other names: Tell-Show-Do, Tell show do, Kaleidoscope glasses

behavior management using the Tell-Show-Do technique.

Behavioral

behavior management using the Tell-Show-Do technique.

Other names: Tell-Show-Do, TSD, tell show do

Primary outcomes

  1. Assessment of pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale

    Time frame: 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.

Secondary outcomes

  1. Assessment of dental anxiety

    Time frame: 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)

  2. Assessment of dental anxiety using Facial Image Scale (FIS)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Nada M. Abdelaziz, Bachelor degree

CONTACT

[email protected]

+201005171751

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 19, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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