- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07595731
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nada M. Abdelaziz, Bachelor degree
- Phone Number: +201005171751
- Email: nada.mosaad@dentistry.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Behavior management using the Tell-Show-Do technique during the treatment.
|
behavior management using the Tell-Show-Do technique.
Other Names:
|
|
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).
Other Names:
|
|
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).
|
behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Child's pain level will be assessed during Local anesthesia injection and pulpotomy by using the FLACC scale.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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)
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).
|
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.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Stomatognathic Diseases
- Tooth Diseases
- Facial Pain
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Toothache
- Organic Chemicals
- Acids, Acyclic
- Carboxylic Acids
- Acrylates
- Polymers
- Macromolecular Substances
- Biomedical and Dental Materials
- Manufactured Materials
- Technology, Industry, and Agriculture
- Plastics
- Resins, Synthetic
- Methylmethacrylates
- Polymethacrylic Acids
- Acrylic Resins
- Polymethyl Methacrylate
Other Study ID Numbers
- KDvsTSD-PAIN-CH-PULP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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