Clinical trial NCT03159793: Evaluation of Different Modelling Techniques on Child Anxiety (RCT)
Official title: Evaluation of Live Modelling and Filmed Modelling Techniques Versus no Modelling on Child Anxiety During Dental Treatment: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 51
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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: i. Diagnosis:

1. History taking \[personal, medical and dental\].
2. Clinical examination using mirror and probe.
3. Radiographic examination to make sure that the caries is simple.
4. Preoperative photograph is taken.

ii. Interventions to each group

1. Group A: Live modelling technique

   1. In the 1st dental visit the operator will start by measuring the behavior of the child by Frankl behavior rating scale.
   2. A cooperative patient will be the model for the child.
   3. 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.
   4. The treatment is performed as follows:

   i. 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
2. 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.

   1. A recorded film will be shown to the child.
   2. 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.
   3. The treatment is performed as follows:

   i. 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.
3. Group C: No modelling

   1. In the 1st dental visit the operator will start by measuring the behavior of the child by Frankl behavior rating scale.
   2. 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.
   3. The treatment is performed as follows:

   i. 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.

Eligibility criteria: Inclusion Criteria:

1. English articles
2. In vivo study (RCT)
3. Medically free children
4. Age group 5-6 years old

Exclusion Criteria:

1. Medically compromised children
2. Adult patients

Primary outcomes:
measure: Dental Anxiety [using Facial Image Scale]
timeFrame: after finishing the procedures in the 2nd dental visit [ after two weeks of allocation]
Secondary outcomes:
measure: Oxygen Saturation [using Pulse oximetry]
timeFrame: Readings are taken in the 2nd dental visit [after two weeks from allocation]
measure: Heart Rate [using Pulse oximetry]
timeFrame: Readings are taken in the 2nd dental visit [after two weeks from allocation]
measure: Patient Cooperation [usind Frankl rating scale]
timeFrame: 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]
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: Cairo University
name: Fatma A El Shehaby, Prof
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Soad Abd El Moniem, Ass. prof
role: STUDY_CHAIR
References: