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
Primary Purpose
Fear Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Video game distraction and video distraction
Sponsored by
About this trial
This is an interventional treatment trial for Fear Anxiety focused on measuring oral health education, distraction, videogame
Eligibility Criteria
Inclusion Criteria:
- Children aged 6-12yrs
- Children requiring simple extraction ( Primary teeth with preshedding mobility)
- Children requiring Infiltration LA only
Exclusion Criteria:
- Children below 6 yrs and above 12 yrs
- Children with special health care needs
- Children requiring complicated extraction
Sites / Locations
- SwarnaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
Group A: Videogame distraction during extraction procedure
Group B: Video distraction during extraction procedure
group C: Verbatim during extraction procedure
Outcomes
Primary Outcome Measures
Reduction in fear during the treatment
Fear will be assessed before, during and after the treatment by assessing the participants pulse rate
Reduction in anxiety during the treatment
Anxiety will be assessed by using chotta-bheem chutki anxiety scale before, during and after the treatment
Secondary Outcome Measures
Improvement in Oral health knowledge
oral health education related questionnaire will be given to the participants before the treatment to assess the baseline measure and knowledge will be assessed again after 1 week
Full Information
NCT ID
NCT03247959
First Posted
July 31, 2017
Last Updated
August 9, 2017
Sponsor
Indira Gandhi Institute of Dental Science
1. Study Identification
Unique Protocol Identification Number
NCT03247959
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indira Gandhi Institute of Dental Science
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
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
Detailed Description
Dentists are expected to identify and effectively treat childhood dental diseases that are within the knowledge and skills acquired during their dental education. As every child is different, safe and effective treatment of oral diseases often requires modifying the child's behavior. Behavior guidance involves interaction of the dentist and dental team, the patient and the parent directed towards communication and education. Its goal is to ease fear and anxiety while promoting an understanding of the need for good oral health.
In 1936, Freud defined Anxiety as an unpleasant affective state or condition, which is characterized by all that is covered by the word 'nervousness' and it can be prevented by the avoidance of negative experiences and promotion of positive experiences in children attending the dental operatory.
In Pediatric dentistry, communicative management and appropriate use of commands have been used in both cooperative and uncooperative child.Commonly used techniques associated with this guiding process are tell-show-do, voice control, nonverbal communication, positive reinforcement and physical restraints. Even though these techniques decrease the perception of unpleasantness, avert negative behaviours, gain or maintain the patient's attention and compliance, it is impossible for pediatric dentists to divert their attention from perceiving pain during invasive dental procedures.
American Academy of Pediatric Dentistry (2008) described distraction as a technique of diverting the patient's attention from what may be perceived as an unpleasant procedure. According to McCaul and Malott, one must attend to the pain stimulus in order to perceive it and also experience the associated distress. Thus distraction might help in reducing the pain perception. As the individual's attentional capacity is finite, a distracting task that requires a great deal of the person's attentional resources should leave little attentional capacity available for processing painful stimuli.
Thus, highly engaging and interactive distraction activities that involve multiple sensory systems are likely to be more effective than more passive distractors or distracters that involve only one or two sensory systems. A number of recent distraction interventions for acute pain in children and adolescents have employed virtual reality (VR) technology in conjunction with either a passive distraction stimulus, such as a movie (Sullivan, Schneider, Musselman, Dummett, & Gardiner, 2000), or an interactive distraction activity, such as a computer game (Dahlquist et al., 2007). However, the actual benefit of VR technology over and above the benefits of the distracting stimulus that is experienced through the VR equipment has not been adequately tested in children.
It is observed from the literature review that only few studies were found on virtual reality distraction and their findings suggest that virtual reality can enhance the effects of distraction for some children and thus demands further research.
Dental problems in children occur due to their poor oral health knowledge and difficulty of parents in implementing healthy oral habits for their children at home. Thus in order to promote oral health knowledge, method of delivering it should be effective. Till date only one study has focused on educating oral health through video game, thus investigators planned this study on videogames as videogames has got extreme potential and is a favourite time pass for children nowadays. The videogame/ video are the interactive tools which would help educate children in a playful way. Hence this study is planned to compare three behaviour guiding techniques (active distraction using videogames, passive distraction using video and verbatim (verbal distraction) in children( participants) for guiding their behavior during dental procedure in a dental operatory. All these three techniques utilize instructions related to oral health. In addition to that, investigators have planned to assess whether these distraction techniques could effectively deliver Oral Health Education to children ( participants).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fear Anxiety
Keywords
oral health education, distraction, videogame
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
114 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Group A: Videogame distraction during extraction procedure
Arm Title
Group B
Arm Type
Experimental
Arm Description
Group B: Video distraction during extraction procedure
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
group C: Verbatim during extraction procedure
Intervention Type
Behavioral
Intervention Name(s)
Video game distraction and video distraction
Intervention Description
video game distraction and video distraction will be advocated during the extraction procedure
Primary Outcome Measure Information:
Title
Reduction in fear during the treatment
Description
Fear will be assessed before, during and after the treatment by assessing the participants pulse rate
Time Frame
30 minutes
Title
Reduction in anxiety during the treatment
Description
Anxiety will be assessed by using chotta-bheem chutki anxiety scale before, during and after the treatment
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Improvement in Oral health knowledge
Description
oral health education related questionnaire will be given to the participants before the treatment to assess the baseline measure and knowledge will be assessed again after 1 week
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged 6-12yrs
Children requiring simple extraction ( Primary teeth with preshedding mobility)
Children requiring Infiltration LA only
Exclusion Criteria:
Children below 6 yrs and above 12 yrs
Children with special health care needs
Children requiring complicated extraction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Swarna Kannan
Phone
8760833345
Email
dentistswarna@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
kayalvizhi Gurusamy, MDS
Phone
9886120559
Email
drfisheyes@yahoo.co.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Swarna Kannan, Postgraduate
Organizational Affiliation
Indira gandhi institute of dental sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swarna
City
Puducherry
State/Province
Pondicherry
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Swarna kannan, postgraduate
Phone
8760833345
Email
dentistswarna@gmail.com
First Name & Middle Initial & Last Name & Degree
Kayalvizhi Gurusamy, MDS
Phone
9886120559
Email
drfisheyes@yahoo.co.in
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
We'll reach out to this number within 24 hrs