Evaluation of Different Modelling Techniques on Child Anxiety (RCT)
Evaluation of Live Modelling and Filmed Modelling Techniques Versus no Modelling on Child Anxiety During Dental Treatment: A Randomized Clinical Trial
1 other identifier
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable anxiety
Started Dec 2017
Typical duration for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2017
CompletedFirst Posted
Study publicly available on registry
May 19, 2017
CompletedStudy Start
First participant enrolled
December 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedJanuary 25, 2018
January 1, 2018
1.2 years
May 16, 2017
January 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Dental Anxiety [using Facial Image Scale]
after finishing the procedures in the 2nd dental visit [ after two weeks of allocation]
Secondary Outcomes (3)
Oxygen Saturation [using Pulse oximetry]
Readings are taken in the 2nd dental visit [after two weeks from allocation]
Heart Rate [using Pulse oximetry]
Readings are taken in the 2nd dental visit [after two weeks from allocation]
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]
Study Arms (3)
Group A
ACTIVE COMPARATORLive Modelling
Group B
ACTIVE COMPARATORFilmed Modelling
Group C
NO INTERVENTIONNo Modelling
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- English articles
- In vivo study (RCT)
- Medically free children
- Age group 5-6 years old
You may not qualify if:
- Medically compromised children
- Adult patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo university
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fatma A El Shehaby, Prof
Cairo University
- STUDY CHAIR
Soad Abd El Moniem, Ass. prof
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
May 16, 2017
First Posted
May 19, 2017
Study Start
December 15, 2017
Primary Completion
March 1, 2019
Study Completion
September 1, 2019
Last Updated
January 25, 2018
Record last verified: 2018-01