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Evaluation of Different Modelling Techniques on Child Anxiety (RCT)

Primary Purpose

Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Live Modelling Technique
Filmed Modelling technique
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

5 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Group A

Group B

Group C

Arm Description

Live Modelling

Filmed Modelling

No Modelling

Outcomes

Primary Outcome Measures

Dental Anxiety [using Facial Image Scale]

Secondary Outcome Measures

Oxygen Saturation [using Pulse oximetry]
Heart Rate [using Pulse oximetry]
Patient Cooperation [usind Frankl rating scale]

Full Information

First Posted
May 16, 2017
Last Updated
January 23, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03159793
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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: 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 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: 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. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Live Modelling
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Filmed Modelling
Arm Title
Group C
Arm Type
No Intervention
Arm Description
No Modelling
Intervention Type
Behavioral
Intervention Name(s)
Live Modelling Technique
Intervention Description
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
Intervention Name(s)
Filmed Modelling technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dental Anxiety [using Facial Image Scale]
Time Frame
after finishing the procedures in the 2nd dental visit [ after two weeks of allocation]
Secondary Outcome Measure Information:
Title
Oxygen Saturation [using Pulse oximetry]
Time Frame
Readings are taken in the 2nd dental visit [after two weeks from allocation]
Title
Heart Rate [using Pulse oximetry]
Time Frame
Readings are taken in the 2nd dental visit [after two weeks from allocation]
Title
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]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English articles In vivo study (RCT) Medically free children Age group 5-6 years old Exclusion Criteria: Medically compromised children Adult patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariam S Yassin, B.D.S.
Phone
+2001112622228
Email
dr.mariamsala7@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma A El Shehaby, Prof
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Soad Abd El Moniem, Ass. prof
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo university
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariam S. Yassin, Master
Phone
01112622228
Email
dr.mariamsala7@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Evaluation of Different Modelling Techniques on Child Anxiety (RCT)

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