Dental Anxiety in ChildrenNCT07595731
Kaleidoscope Compared to Tell-Show-Do for Reducing Children Pain and Anxiety During Pulp Therapy
A study testing behavior management using Kaleidoscope glasses (SOL, country of origin: China)., behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China). and behavior management using the Tell-Show-Do technique. in people with Dental Anxiety in Children and Dental Pain, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety in Children, Dental Pain
- What is being tested?
- behavior management using Kaleidoscope glasses (SOL, country of origin: China)., behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China). and behavior management using the Tell-Show-Do technique.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Children with systemic or mental disorders.
- Children without parental consent.
- Children complaining of acute dental pain.
- Children receiving analgesics within the last 48 hours.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read more
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
- Being tested
- behavior management using Kaleidoscope glasses (SOL, country of origin: China)., behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China)., behavior management using the Tell-Show-Do technique.
- Keywords
- managing dental pain in children, dental pain, dental pain in children, children anxiety, dental anxiety in children, behavior management, dental distraction
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavior management using Kaleidoscope glasses (SOL, country of origin: China).Behavioural
Also called Kaleidoscope glasses (SOL, country of origin: China)., Kaleidoscope glasses, Kaleidoscope distarction
behavior management using Kaleidoscope glasses (SOL, country of origin: China).
behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China).Behavioural
Also called Tell-Show-Do, Tell show do, Kaleidoscope glasses
behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China).
behavior management using the Tell-Show-Do technique.Behavioural
Also called Tell-Show-Do, TSD, tell show do
behavior management using the Tell-Show-Do technique.
| Study group | Role | What they receive |
|---|---|---|
| Behavior management using the Tell-Show-Do technique during the treatment. | Active comparator | Behavior management using the Tell-Show-Do technique during the treatment. Receives: 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. Receives: 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). Receives: Behavioral: behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Assessment of dental anxiety using finger Pulse oximeter (Quantitative outcome) scores(beats/min)
Measured: 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)
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Anxiety in ChildrenStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Mosaad Abdel-Aziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595731
- Sponsor's protocol ID
- KDvsTSD-PAIN-CH-PULP
- Status last verified
- Jun 2026
- First submitted
- 6 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07595731
- Acronym / sponsor ID
- KDvsTSD-PAIN-CH-PULP
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavior management using the Tell-Show-Do technique during the treatment. | Active comparator | Behavioral: behavior management using the Tell-Show-Do technique.Behavior management using the Tell-Show-Do technique during the treatment. |
| behavior management using Kaleidoscope glasses. | Experimental | Behavioral: behavior management using Kaleidoscope glasses (SOL, country of origin: China).behavior management while the child is wearing Kaleidoscope glasses (SOL, country of origin: China) during the treatment. |
| behavior management using the Tell-Show-Do technique and Kaleidoscope glasses | Experimental | Behavioral: 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 while the child is wearing Kaleidoscope glasses (SOL, country of origin: China). |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Children with systemic or mental disorders.
- Children without parental consent.
- Children complaining of acute dental pain.
- Children receiving analgesics within the last 48 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavior management using Kaleidoscope glasses (SOL, country of origin: China).Also: Kaleidoscope glasses (SOL, country of origin: China)., Kaleidoscope glasses, Kaleidoscope distarctionbehavior management using Kaleidoscope glasses (SOL, country of origin: China). | Behavioural | behavior management using Kaleidoscope glasses. |
| behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China).Also: Tell-Show-Do, Tell show do, Kaleidoscope glassesbehavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China). | Behavioural | behavior management using the Tell-Show-Do technique and Kaleidoscope glasses |
| behavior management using the Tell-Show-Do technique.Also: Tell-Show-Do, TSD, tell show dobehavior management using the Tell-Show-Do technique. | Behavioural | Behavior management using the Tell-Show-Do technique during the treatment. |
Primary outcome
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.
2 secondary outcomes
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 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing behavior management using Kaleidoscope glasses (SOL, country of origin: China)., behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China). and behavior management using the Tell-Show-Do technique. in people with Dental Anxiety in Children and Dental Pain, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nada M. Abdelaziz, Bachelor degree (+201005171751, nada.mosaad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.