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

NCT07595731 | Not Yet Recruiting DMC

• 1 other identifier: KDvsTSD-PAIN-CH-PULP
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dental Anxiety in Children; Dental Pain

Keywords

managing dental pain in children; dental pain; dental pain in children; children anxiety; dental anxiety in children; behavior management; dental distraction

Outcome Measures

Primary Outcomes (1)

• Assessment of pain using the Face, Legs, Activity, Cry, Consolability (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.

Secondary Outcomes (2)

• Assessment of dental anxiety

  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)

  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.

Study Arms (3)

Behavior management using the Tell-Show-Do technique during the treatment.

ACTIVE COMPARATOR

Behavior management using the Tell-Show-Do technique during the treatment.

Behavioral: behavior management using the Tell-Show-Do technique.

behavior management using Kaleidoscope glasses.

EXPERIMENTAL

behavior management while the child is wearing Kaleidoscope glasses (SOL, country of origin: China) during the treatment.

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

behavior management using the Tell-Show-Do technique and Kaleidoscope glasses

EXPERIMENTAL

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

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

Interventions

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

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

Also known as: Kaleidoscope glasses (SOL, country of origin: China)., Kaleidoscope glasses, Kaleidoscope distarction

behavior management using Kaleidoscope glasses.

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).

Also known as: Tell-Show-Do, Tell show do, Kaleidoscope glasses

behavior management using the Tell-Show-Do technique and Kaleidoscope glasses

behavior management using the Tell-Show-Do technique. BEHAVIORAL

behavior management using the Tell-Show-Do technique.

Also known as: Tell-Show-Do, TSD, tell show do

Behavior management using the Tell-Show-Do technique during the treatment.

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Toothache

Interventions

Polymethyl Methacrylate

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methylmethacrylates; Polymethacrylic Acids; Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Acrylic Resins; Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Candidate

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share