AnxietyNCT04833478
Comparison of Efficacy of Little Lovely Dentist, Dental Song and Tell-show-do Techniques in Alleviating Dental Anxiety in Paediatric Patients
A study testing Anxiety in people with Anxiety and Paediatric, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
Trial summary
To evaluate the efficacy of different techniques for the reduction of dental anxiety in pediatric patients. Generally, anxiety amongst paediatric patients is higher as compared to adult patients. Read more about this study
- Who is it for?
- Ages 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Paediatric, Dental Anxiety
- What is being tested?
- Anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2020to 31 Dec 2020
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Only the children age ranged from 4 to 11 years with no positive medical history.
Who cannot join
- Rest were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy of Little Lovely Dentist, Dental Song and Tell-show-do Techniques in Alleviating Dental Anxiety in Paediatric Patients -A Single Blind Randomized Controlled Trial
To evaluate the efficacy of different techniques for the reduction of dental anxiety in pediatric patients. Generally, anxiety amongst paediatric patients is higher as compared to adult patients. So different modalities are used by the dentists in order to reduce the anxiety of such patient to help to make treatment procedures easier and optimal.
Read the detailed description
Children who suffer from dental anxiety avoid any sort of dental treatment provided to them, which leads to poor oral hygiene, and if unaddressed, problems like missing teeth and decayed teeth further in life develop, and ultimately leading to problems making treatment planning intricate. Children normally follow the footsteps of their parents so it is of importance to consider how to avoid creating dental anxiety among them. If dental anxiety is left untreated, it might persist during adulthood, which eventually will deteriorate the oral health of such patients. Due to the substantial effect of dental anxiety in paediatric patients, many methods have been devised to alleviate or eliminate such anxieties of the patients. This study aimed to employ different strategies and measure heart rate and Facial Image Scale scores to determine their efficacy in reducing paediatric patient's dental anxiety by using these techniques before and after the procedure to compare the effectiveness of each of these techniques.
- Conditions
- Anxiety, Paediatric, Dental Anxiety, Behaviour
- Being tested
- Anxiety
- Keywords
- Anxiety, Dental Application, Dental Song, Tell-Show-Do, Behaviour
- Medical subject headings
- Anxiety Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnxietyBehavioural
Techniques used to reduce anxiety in paediatric patients.
| Study group | Role | What they receive |
|---|---|---|
| Application | Experimental | Measuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter Receives: Behavioral: Anxiety |
| Dental Song | Experimental | Measuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter Receives: Behavioral: Anxiety |
| Tell Show Do | Experimental | Measuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter Receives: Behavioral: Anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group 1: Little Lovely Dentist App measuring anxiety using pulse oximeter
Measuring Anxiety Levels
Measured: 5 months
Group 1: Little Lovely Dentist App measuring anxiety using facial image scale.
Measuring Anxiety Levels, 1 Minimum value and 5 Maximum value
Measured: 5 months
Group 2: Dental Song measuring anxiety using pulse oximeter
Measuring Anxiety Levels
Measured: 5 months
Group 2: Dental Song measuring anxiety using facial image scale.
Measuring Anxiety Levels, 1 Minimum value and 5 Maximum value
Measured: 5 months
Group 3: Tell-Show-Do measuring anxiety using pulse oximeter
Measuring Anxiety Levels
Measured: 5 months
Group 3: Tell-Show-Do measuring anxiety using facial image scale.
Measuring Anxiety Levels 1 Minimum value and 5 Maximum value
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Aug 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altamash Institute of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hira Abbasi, Altamash Institute of Dental Medicine
- Investigators
- Hira Abbasi, BDS, Post Graduate Trainee, Principal investigator, Altamash Institute of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833478
- Sponsor's protocol ID
- Paeds Anxiety
- Status last verified
- Apr 2021
- First submitted
- 16 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Little Lovely Dentist, Dental Song and Tell-show-do Techniques in Alleviating Dental Anxiety in Paediatric Patients -A Single Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04833478
- Acronym / sponsor ID
- Paeds Anxiety
- Conditions
- Anxiety, Paediatric, Dental Anxiety, Behaviour
- Keywords
- Anxiety, Dental Application, Dental Song, Tell-Show-Do, Behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Altamash Institute of Dental MedicineUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 Apr 2021 (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.
To evaluate the efficacy of different techniques for the reduction of dental anxiety in pediatric patients. Generally, anxiety amongst paediatric patients is higher as compared to adult patients. So different modalities are used by the dentists in order to reduce the anxiety of such patient to help to make treatment procedures easier and optimal.
Detailed description
Children who suffer from dental anxiety avoid any sort of dental treatment provided to them, which leads to poor oral hygiene, and if unaddressed, problems like missing teeth and decayed teeth further in life develop, and ultimately leading to problems making treatment planning intricate. Children normally follow the footsteps of their parents so it is of importance to consider how to avoid creating dental anxiety among them. If dental anxiety is left untreated, it might persist during adulthood, which eventually will deteriorate the oral health of such patients. Due to the substantial effect of dental anxiety in paediatric patients, many methods have been devised to alleviate or eliminate such anxieties of the patients. This study aimed to employ different strategies and measure heart rate and Facial Image Scale scores to determine their efficacy in reducing paediatric patient's dental anxiety by using these techniques before and after the procedure to compare the effectiveness of each of these techniques.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Application | Experimental | Behavioral: AnxietyMeasuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter |
| Dental Song | Experimental | Behavioral: AnxietyMeasuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter |
| Tell Show Do | Experimental | Behavioral: AnxietyMeasuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Only the children age ranged from 4 to 11 years with no positive medical history.
Key exclusion criteria (1 listed)
- Rest were excluded.
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 |
|---|---|---|
| AnxietyTechniques used to reduce anxiety in paediatric patients. | Behavioural | Application, Dental Song, Tell Show Do |
Primary outcome
Group 1: Little Lovely Dentist App measuring anxiety using pulse oximeter
Time frame: 5 months
Measuring Anxiety Levels
Group 1: Little Lovely Dentist App measuring anxiety using facial image scale.
Time frame: 5 months
Measuring Anxiety Levels, 1 Minimum value and 5 Maximum value
Group 2: Dental Song measuring anxiety using pulse oximeter
Time frame: 5 months
Measuring Anxiety Levels
Group 2: Dental Song measuring anxiety using facial image scale.
Time frame: 5 months
Measuring Anxiety Levels, 1 Minimum value and 5 Maximum value
Group 3: Tell-Show-Do measuring anxiety using pulse oximeter
Time frame: 5 months
Measuring Anxiety Levels
Group 3: Tell-Show-Do measuring anxiety using facial image scale.
Time frame: 5 months
Measuring Anxiety Levels 1 Minimum value and 5 Maximum value
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
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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.
Hira Abbasi, BDS, Post Graduate Trainee principal investigator
Altamash Institute of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anxiety in people with Anxiety and Paediatric, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group 1: Little Lovely Dentist App measuring anxiety using pulse oximeter (time frame: 5 months). The study lists 6 primary outcomes in all. 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 6 Apr 2021.