Dental AnxietyNCT04262063
Effectiveness of TPD Tech VS TSD Tech
A study testing Tell play do technique and tell show do in people with Dental Anxiety, run by rehab abdulhameed ebrahim mohammed.
Trial summary
Assessment of the effectiveness of tell play do technique and tell show do technique in management of anxious children . 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
- What is being tested?
- Tell play do technique and tell show do
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 with Frankl's behavior rating score of 1,2 .
- Patients with no previous dental experience.
- Patients not suffering from cognitive or mental problems.
- Children with primary molars indicated for extraction .
- Age 4- 6 years old .
Who cannot join
- Medically compromised patients
- Patients suffering from cognitive or mental problems
- Patients with previous dental experience
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Tell Play do Technique in Comparison to Tell Show do Technique for the Management of Anxious Children: A Randomized Controlled Trial
Assessment of the effectiveness of tell play do technique and tell show do technique in management of anxious children .
Read the detailed description
Child dental anxiety has been a matter of concern for many years. It is defined as a nonspecific feeling of apprehension, worry, uneasiness and the source may be not clear or unknown .
Dental anxiety is considered as a major obstacle for the dental treatment. The dental appointment is a stressful situation specially for children which raises their anxiety level. Different studies among 6-12 years old children showed that 20%- 43 % exhibited high dental fear and anxiety .
Dental fear and anxiety can have negative implications for children's oral health. There is certainty for the negative impact of dental anxiety on the oral health-related quality of life of children, and studies have shown that children with dental fear and anxiety have worse oral health status than their peers (more untreated carious lesions).
It is also children with dental fear and anxiety may present with behavioral management problems which can disrupt the provision of dental treatment and negatively impact on the dental treatment the child receives. The anxiety experienced by children is not only distressing for the child, but it can also be a potentially stressful and upsetting experience for their parents .
A good patient-dentist relationship is crucial for the management of anxiety. It is the responsibility of pedodontists to make dentistry as child-friendly and pain-free as possible to bring about positive changes in the behavior of children during dental treatment .
Tell-show-do technique is widely used for managing pediatric dental patients. It is useful for almost all patients who can communicate, especially those patients who are 'monitors. Although widely used, the ability of this technique to prepare, and reduce child anxiety remains an area for research, because it's not always appropriate for those patients who are 'blunters' where detailed information can result in increased levels of anxiety .
So different modifications of this technique were used one of them is tell play do technique with a dental imitation toy and using euphemisms instead of demonstrating on a model or observing one. Tell play do technique provides a better explanatory concept of the dental procedure and can lead to more cooperation of the children patients which can influence the dental treatment in a good and positive way.
- Conditions
- Dental Anxiety
- Being tested
- Tell play do technique, tell show do
- Keywords
- tell show do, tell play do, dental anxiety, child behavior
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tell play do techniqueBehavioural
it apply the concept of learning by doing .children will enjoy playing with customized dental models
tell show doBehavioural
Tell: your dentist explaining to you what they'd like to do Show: showing you what is involved (e. g. showing the equipment and demonstrating it on a finger) Do: performing the procedure
| Study group | Role | What they receive |
|---|---|---|
| tell play do technique | Experimental | Tell play do technique with a dental imitation toy and using euphemisms instead of demonstrating on a model or observing one. Tell play do technique provides a better explanatory concept of the dental procedure and can lead to more cooperation of the children patients which can influence the dental treatment in a good and positive way. Receives: Behavioral: Tell play do technique |
| tell show do technique | Active comparator | Tell show do is the gold standard of the non-pharmacological behavior management techniques. It is based on the principle of learning theory and it is performed by the dentists themselves . It is the most important behavior modification technique practiced by dentists and it is commonly used for management of children anxiety in the first dental visit . Receives: Behavioral: tell show do |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of anxiety
The level of dental anxiety of each patient will be assessed using finger pulse oximeter.
Measured: Immediate In the first visit
Secondary outcomes (3)
change in behavior
the operator will grade the child's behavior during the procedure using the (Face, Leg, Activity, Cry, Consolability) behavioral pain assessment scale.(FLACC)
each category scores from 0-2 scale which result in a total score of 0-10
0 relaxed and comfortable 1-3 mild discomfort 4-6 moderate pain 7-10 severe discomfort of pain or both
Measured: immediate after the behavior management
Ease of handling patients
The ease of handling the patient will be assessed using a validated questionnaire by 5-point Likert scale (1- Strong positive , 2- Positive, 3- Neutral , 4- Negative,5- Strong negative)
Measured: immediate the end of the treatment
Ease of doing the procedures
the ease of doing the procedures will be assessed using a validated questionnaire by 5-point Likert scale (1- Strong positive , 2- Positive, 3- Neutral , 4- Negative, 5- Strong negative)
Measured: immediate at the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study startDec 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel group two arms superiority trial with 1:1 allocation ratio
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- rehab abdulhameed ebrahim mohammed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, rehab abdulhameed ebrahim mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262063
- Sponsor's protocol ID
- eff of TPD vsTSD
- Status last verified
- Jun 2020
- First submitted
- 2 Feb 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- 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 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tell Play do Technique in Comparison to Tell Show do Technique for the Management of Anxious Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04262063
- Acronym / sponsor ID
- eff of TPD vsTSD
- Conditions
- Dental Anxiety
- Keywords
- tell show do, tell play do, dental anxiety, child behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- rehab abdulhameed ebrahim mohammedUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 10 Feb 2020 (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.
Assessment of the effectiveness of tell play do technique and tell show do technique in management of anxious children .
Detailed description
Child dental anxiety has been a matter of concern for many years. It is defined as a nonspecific feeling of apprehension, worry, uneasiness and the source may be not clear or unknown .
Dental anxiety is considered as a major obstacle for the dental treatment. The dental appointment is a stressful situation specially for children which raises their anxiety level. Different studies among 6-12 years old children showed that 20%- 43 % exhibited high dental fear and anxiety .
Dental fear and anxiety can have negative implications for children's oral health. There is certainty for the negative impact of dental anxiety on the oral health-related quality of life of children, and studies have shown that children with dental fear and anxiety have worse oral health status than their peers (more untreated carious lesions).
It is also children with dental fear and anxiety may present with behavioral management problems which can disrupt the provision of dental treatment and negatively impact on the dental treatment the child receives. The anxiety experienced by children is not only distressing for the child, but it can also be a potentially stressful and upsetting experience for their parents .
A good patient-dentist relationship is crucial for the management of anxiety. It is the responsibility of pedodontists to make dentistry as child-friendly and pain-free as possible to bring about positive changes in the behavior of children during dental treatment .
Tell-show-do technique is widely used for managing pediatric dental patients. It is useful for almost all patients who can communicate, especially those patients who are 'monitors. Although widely used, the ability of this technique to prepare, and reduce child anxiety remains an area for research, because it's not always appropriate for those patients who are 'blunters' where detailed information can result in increased levels of anxiety .
So different modifications of this technique were used one of them is tell play do technique with a dental imitation toy and using euphemisms instead of demonstrating on a model or observing one. Tell play do technique provides a better explanatory concept of the dental procedure and can lead to more cooperation of the children patients which can influence the dental treatment in a good and positive way.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- parallel group two arms superiority trial with 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| tell play do technique | Experimental | Behavioral: Tell play do techniqueTell play do technique with a dental imitation toy and using euphemisms instead of demonstrating on a model or observing one. Tell play do technique provides a better explanatory concept of the dental procedure and can lead to more cooperation of the children patients which can influence the dental treatment in a good and positive way. |
| tell show do technique | Active comparator | Behavioral: tell show doTell show do is the gold standard of the non-pharmacological behavior management techniques. It is based on the principle of learning theory and it is performed by the dentists themselves . It is the most important behavior modification technique practiced by dentists and it is commonly used for management of children anxiety in the first dental visit . |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children with Frankl's behavior rating score of 1,2 .
- Patients with no previous dental experience.
- Patients not suffering from cognitive or mental problems.
- Children with primary molars indicated for extraction .
- Age 4- 6 years old .
Key exclusion criteria (3 listed)
- Medically compromised patients
- Patients suffering from cognitive or mental problems
- Patients with previous dental experience
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 |
|---|---|---|
| Tell play do techniqueit apply the concept of learning by doing .children will enjoy playing with customized dental models | Behavioural | tell play do technique |
| tell show doTell: your dentist explaining to you what they'd like to do Show: showing you what is involved (e. g. showing the equipment and demonstrating it on a finger) Do: performing the procedure | Behavioural | tell show do technique |
Primary outcome
level of anxiety
Time frame: Immediate In the first visit
The level of dental anxiety of each patient will be assessed using finger pulse oximeter.
3 secondary outcomes
change in behavior
Time frame: immediate after the behavior management
Ease of handling patients
Time frame: immediate the end of the treatment
Ease of doing the procedures
Time frame: immediate at the end of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Tell play do technique and tell show do in people with Dental Anxiety, run by rehab abdulhameed ebrahim mohammed.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rehab mohammed, master (01152349678, rehab.ebrahim@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of anxiety (time frame: Immediate In the first visit). 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 14 Jul 2020.