Evaluation of Different Modelling Techniques on Child Anxiety (RCT)

Anxiety Clinical Trial

Official title:

Evaluation of Live Modelling and Filmed Modelling Techniques Versus no Modelling on Child Anxiety During Dental Treatment: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03159793
• Other study ID #: Protocol Paper
• Status: Recruiting
• Phase: N/A
• First received: May 16, 2017
• Last updated: January 23, 2018
• Start date: December 15, 2017
• Est. completion date: September 2019

Study information

• Verified date: January 2018
• Source: Cairo University
• Contact: Mariam S Yassin, B.D.S.
• Phone: +2001112622228
• Email: dr.mariamsala7[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: September 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Live Modelling Technique
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 technique
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.

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental Anxiety [using Facial Image Scale]		after finishing the procedures in the 2nd dental visit [ after two weeks of allocation]
Secondary	Oxygen Saturation [using Pulse oximetry]		Readings are taken in the 2nd dental visit [after two weeks from allocation]
Secondary	Heart Rate [using Pulse oximetry]		Readings are taken in the 2nd dental visit [after two weeks from allocation]
Secondary	Patient Cooperation [usind Frankl rating scale]		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]