AnxietyNCT03159793
Evaluation of Different Modelling Techniques on Child Anxiety (RCT)
A study testing Live Modelling Technique and Filmed Modelling technique in people with Anxiety, run by Cairo University at 1 site in Egypt.
Trial summary
A huge number of children suffer from anxiety during their dental treatment especially those who did not receive any type of behavior management during their first dental visit. This will result in a more complicated treatment sessions for the children, dentist and the parents. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Live Modelling Technique and Filmed Modelling technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2017to Sep 2019
- 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 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- English articles
- In vivo study (RCT)
- Medically free children
- Age group 5-6 years old
Who cannot join
- Medically compromised children
- Adult patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Cairo
Mariam S. Yassin, Master, 01112622228, dr.mariamsala7@gmail.com
About this study
Official title: Evaluation of Live Modelling and Filmed Modelling Techniques Versus no Modelling on Child Anxiety During Dental Treatment: A Randomized Clinical Trial
A huge number of children suffer from anxiety during their dental treatment especially those who did not receive any type of behavior management during their first dental visit. This will result in a more complicated treatment sessions for the children, dentist and the parents. Fear and anxiety control is the key to change the resistant nature of the anxious patients and also allow them to receive the proper treatment they require. From the point of view that there is no difference between the techniques effectiveness, evaluation of two modelling techniques (live modelling and filmed modelling versus no modelling) for children anxious behavior management during the dental treatment will be performed.
Read the detailed description
- Diagnosis:
- History taking [personal, medical and dental].
- Clinical examination using mirror and probe.
- Radiographic examination to make sure that the caries is simple.
- Preoperative photograph is taken. ii. Interventions to each group
- Group A: Live modelling technique
- In the 1st dental visit the operator will start by measuring the behavior of the child by Frankl behavior rating scale.
- A cooperative patient will be the model for the child.
- In the 2nd dental visit the pulse oximetry device will be installed on the child's finger and another form of Frankl behavior rating scale is filled.
- The treatment is performed as follows:
- Place topical anesthesia. ii. Place anesthetic injection. iii. Cavity preparation. iv. Filling material placement. v. Finishing of the filling. e. The child will be asked to complete a facial image scale
- Group B: video modelling technique (1) In the 1st dental visit the operator will start by measuring the behavior of the child by Frankl behavior rating scale.
- A recorded film will be shown to the child.
- In the 2nd dental visit the pulse oximetry device will be installed on the child's finger and another form of Frankl behavior rating scale is filled.
- The treatment is performed as follows:
- Place topical anesthesia. ii. Place anesthetic injection. iii. Cavity preparation. iv. Filling material placement. v. Finishing of the filling. d. The child will be asked to complete a facial image scale.
- Group C: No modelling
- In the 1st dental visit the operator will start by measuring the behavior of the child by Frankl behavior rating scale.
- In the 2nd dental visit the pulse oximetry device will be installed on the child's finger and another form to Frankl behavior rating scale.
- The treatment is performed as follows:
- Place topical anesthesia. ii. Place anesthetic injection. iii. Cavity preparation. iv. Filling material places. v. Finishing of the filling. d. The child will be asked to complete a facial image scale.
- Conditions
- Anxiety
- Being tested
- Live Modelling Technique, Filmed Modelling technique
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Modelling TechniqueBehavioural
Direct observation is the term used to describe both the filmed and live modelling technique. These techniques depend on familiarizing the patient with the dental environment and allowing the patient to ask the questions he/she wants to ask. The patients are shown a film or are permitted to directly observe a cooperative patient undergoing dental treatment. These techniques have no contra indications they simply may be used with any patient.
Filmed Modelling techniqueBehavioural
Direct observation is the term used to describe both the filmed and live modelling technique. These techniques depend on familiarizing the patient with the dental environment and allowing the patient to ask the questions he/she wants to ask. The patients are shown a film or are permitted to directly observe a cooperative patient undergoing dental treatment. These techniques have no contra indications they simply may be used with any patient.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Live Modelling Receives: Behavioral: Live Modelling Technique |
| Group B | Active comparator | Filmed Modelling Receives: Behavioral: Filmed Modelling technique |
| Group C | No intervention | No Modelling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Anxiety [using Facial Image Scale]
Measured: after finishing the procedures in the 2nd dental visit [ after two weeks of allocation]
Secondary outcomes (3)
Oxygen Saturation [using Pulse oximetry]
Measured: Readings are taken in the 2nd dental visit [after two weeks from allocation]
Heart Rate [using Pulse oximetry]
Measured: Readings are taken in the 2nd dental visit [after two weeks from allocation]
Patient Cooperation [usind Frankl rating scale]
Measured: This is perfomred in the allocation visit , in the 1st dental visit [ after a week from allocation], in the 2nd visit [ after two weeks from allocation]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start15 Dec 2017
- Primary completionMar 2019 (estimated)
- Study completionSep 2019 (estimated)
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.
- 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
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Salah Mohammad Yassin, Cairo University
- Investigators
- Fatma A El Shehaby, Prof, Study director, Cairo UniversitySoad Abd El Moniem, Ass. prof, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159793
- Sponsor's protocol ID
- Protocol Paper
- Status last verified
- Jan 2018
- First submitted
- 16 May 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Live Modelling and Filmed Modelling Techniques Versus no Modelling on Child Anxiety During Dental Treatment: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03159793
- Acronym / sponsor ID
- Protocol Paper
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 19 May 2017 (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.
A huge number of children suffer from anxiety during their dental treatment especially those who did not receive any type of behavior management during their first dental visit. This will result in a more complicated treatment sessions for the children, dentist and the parents. Fear and anxiety control is the key to change the resistant nature of the anxious patients and also allow them to receive the proper treatment they require. From the point of view that there is no difference between the techniques effectiveness, evaluation of two modelling techniques (live modelling and filmed modelling versus no modelling) for children anxious behavior management during the dental treatment will be performed.
Detailed description
- Diagnosis:
- History taking [personal, medical and dental].
- Clinical examination using mirror and probe.
- Radiographic examination to make sure that the caries is simple.
- Preoperative photograph is taken. ii. Interventions to each group
- Group A: Live modelling technique
- In the 1st dental visit the operator will start by measuring the behavior of the child by Frankl behavior rating scale.
- A cooperative patient will be the model for the child.
- In the 2nd dental visit the pulse oximetry device will be installed on the child's finger and another form of Frankl behavior rating scale is filled.
- The treatment is performed as follows:
- Place topical anesthesia. ii. Place anesthetic injection. iii. Cavity preparation. iv. Filling material placement. v. Finishing of the filling. e. The child will be asked to complete a facial image scale
- Group B: video modelling technique (1) In the 1st dental visit the operator will start by measuring the behavior of the child by Frankl behavior rating scale.
- A recorded film will be shown to the child.
- In the 2nd dental visit the pulse oximetry device will be installed on the child's finger and another form of Frankl behavior rating scale is filled.
- The treatment is performed as follows:
- Place topical anesthesia. ii. Place anesthetic injection. iii. Cavity preparation. iv. Filling material placement. v. Finishing of the filling. d. The child will be asked to complete a facial image scale.
- Group C: No modelling
- In the 1st dental visit the operator will start by measuring the behavior of the child by Frankl behavior rating scale.
- In the 2nd dental visit the pulse oximetry device will be installed on the child's finger and another form to Frankl behavior rating scale.
- The treatment is performed as follows:
- Place topical anesthesia. ii. Place anesthetic injection. iii. Cavity preparation. iv. Filling material places. v. Finishing of the filling. d. The child will be asked to complete a facial image scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Behavioral: Live Modelling TechniqueLive Modelling |
| Group B | Active comparator | Behavioral: Filmed Modelling techniqueFilmed Modelling |
| Group C | No intervention | –No Modelling |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- English articles
- In vivo study (RCT)
- Medically free children
- Age group 5-6 years old
Key exclusion criteria (2 listed)
- Medically compromised children
- Adult patients
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 |
|---|---|---|
| Live Modelling TechniqueDirect observation is the term used to describe both the filmed and live modelling technique. These techniques depend on familiarizing the patient with the dental environment and allowing the patient to ask the questions he/she wants to ask. The patients are shown a film or are permitted to directly observe a cooperative patient undergoing dental treatment. These techniques have no contra indications they simply may be used with any patient. | Behavioural | Group A |
| Filmed Modelling techniqueDirect observation is the term used to describe both the filmed and live modelling technique. These techniques depend on familiarizing the patient with the dental environment and allowing the patient to ask the questions he/she wants to ask. The patients are shown a film or are permitted to directly observe a cooperative patient undergoing dental treatment. These techniques have no contra indications they simply may be used with any patient. | Behavioural | Group B |
Primary outcome
Dental Anxiety [using Facial Image Scale]
Time frame: after finishing the procedures in the 2nd dental visit [ after two weeks of allocation]
3 secondary outcomes
Oxygen Saturation [using Pulse oximetry]
Time frame: Readings are taken in the 2nd dental visit [after two weeks from allocation]
Heart Rate [using Pulse oximetry]
Time frame: Readings are taken in the 2nd dental visit [after two weeks from allocation]
Patient Cooperation [usind Frankl rating scale]
Time frame: This is perfomred in the allocation visit , in the 1st dental visit [ after a week from allocation], in the 2nd visit [ after two weeks from allocation]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Fatma A El Shehaby, Prof study director
Cairo University
Soad Abd El Moniem, Ass. prof study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Modelling Technique and Filmed Modelling technique in people with Anxiety, run by Cairo University at 1 site in Egypt.
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 2 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 25 Jan 2018. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam S Yassin, B.D.S. (+2001112622228, dr.mariamsala7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental Anxiety [using Facial Image Scale] (time frame: after finishing the procedures in the 2nd dental visit [ after two weeks of allocation]). 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 25 Jan 2018.