Effectiveness of Active and Passive Distraction Techniques on Reducing Fear and Anxiety and Improving Oral Health Knowledge of Children Undergoing Extraction in the Dental Operatory- A Randomized Controlled Trial
1 other identifier
interventional
114
1 country
1
Brief Summary
The Purpose of this study is to evaluate the effectiveness of active ( video game) and passive (video) distraction techniques on reducing fear and anxiety and improving oral health knowledge of children undergoing extraction in the dental operatory
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 3, 2017
CompletedFirst Submitted
Initial submission to the registry
July 31, 2017
CompletedFirst Posted
Study publicly available on registry
August 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedAugust 14, 2017
August 1, 2017
8 months
July 31, 2017
August 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reduction in fear during the treatment
Fear will be assessed before, during and after the treatment by assessing the participants pulse rate
30 minutes
Reduction in anxiety during the treatment
Anxiety will be assessed by using chotta-bheem chutki anxiety scale before, during and after the treatment
30 minutes
Secondary Outcomes (1)
Improvement in Oral health knowledge
1 week
Study Arms (3)
Group A
EXPERIMENTALGroup A: Videogame distraction during extraction procedure
Group B
EXPERIMENTALGroup B: Video distraction during extraction procedure
Group C
ACTIVE COMPARATORgroup C: Verbatim during extraction procedure
Interventions
video game distraction and video distraction will be advocated during the extraction procedure
Eligibility Criteria
You may qualify if:
- Children aged 6-12yrs
- Children requiring simple extraction ( Primary teeth with preshedding mobility)
- Children requiring Infiltration LA only
You may not qualify if:
- Children below 6 yrs and above 12 yrs
- Children with special health care needs
- Children requiring complicated extraction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Swarna
Puducherry, Puducherry, India
Study Officials
- PRINCIPAL INVESTIGATOR
Swarna Kannan, Postgraduate
Indira gandhi institute of dental sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 31, 2017
First Posted
August 14, 2017
Study Start
April 3, 2017
Primary Completion
December 1, 2017
Study Completion
July 1, 2018
Last Updated
August 14, 2017
Record last verified: 2017-08