Evaluation of Different Modelling Techniques on Child Anxiety (RCT)

NCT ID: NCT03159793

Last Updated: 2018-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group A

Live Modelling

Group Type ACTIVE_COMPARATOR

Live Modelling Technique

Intervention Type BEHAVIORAL

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.

Group B

Filmed Modelling

Group Type ACTIVE_COMPARATOR

Filmed Modelling technique

Intervention Type BEHAVIORAL

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.

Group C

No Modelling

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mariam Salah Mohammad Yassin

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatma A El Shehaby, Prof

Role: STUDY_DIRECTOR

Cairo University

Soad Abd El Moniem, Ass. prof

Role: STUDY_CHAIR

Cairo University

Locations

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Cairo university

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mariam S Yassin, B.D.S.

Role: CONTACT

+2001112622228

Facility Contacts

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Mariam S. Yassin, Master

Role: primary

01112622228

Other Identifiers

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Protocol Paper

Identifier Type: -

Identifier Source: org_study_id

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