Fear AnxietyNCT03247959
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
A study testing Video game distraction and video distraction in people with Fear Anxiety, run by Indira Gandhi Institute of Dental Science at 1 site in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Fear Anxiety
- What is being tested?
- Video game distraction and video distraction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteIndia
- Study dates
- 3 Apr 2017to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-12yrs
- Children requiring simple extraction ( Primary teeth with preshedding mobility)
- Children requiring Infiltration LA only
Who cannot join
- Children below 6 yrs and above 12 yrs
- Children with special health care needs
- Children requiring complicated extraction
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Swarna
Puducherry, Puducherry
Swarna kannan, postgraduate, 8760833345, dentistswarna@gmail.com
Kayalvizhi Gurusamy, MDS, 9886120559, drfisheyes@yahoo.co.in
About this study
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
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
Read the 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).
- Conditions
- Fear Anxiety
- Being tested
- Video game distraction and video distraction
- Keywords
- oral health education, distraction, videogame
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video game distraction and video distractionBehavioural
video game distraction and video distraction will be advocated during the extraction procedure
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A: Videogame distraction during extraction procedure Receives: Behavioral: Video game distraction and video distraction |
| Group B | Experimental | Group B: Video distraction during extraction procedure Receives: Behavioral: Video game distraction and video distraction |
| Group C | Active comparator | group C: Verbatim during extraction procedure Receives: Behavioral: Video game distraction and video distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in fear during the treatment
Fear will be assessed before, during and after the treatment by assessing the participants pulse rate
Measured: 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
Measured: 30 minutes
Secondary outcomes (1)
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start3 Apr 2017
- Primary completionDec 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indira Gandhi Institute of Dental Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Swarna Kannan, Indira Gandhi Institute of Dental Science
- Investigators
- Swarna Kannan, Postgraduate, Principal investigator, Indira gandhi institute of dental sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247959
- Sponsor's protocol ID
- IGIDSIRB2016NDP27PGSKPPD
- Status last verified
- Aug 2017
- First submitted
- 31 Jul 2017
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03247959
- Acronym / sponsor ID
- IGIDSIRB2016NDP27PGSKPPD
- Conditions
- Fear Anxiety
- Keywords
- oral health education, distraction, videogame
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Indira Gandhi Institute of Dental ScienceUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Video game distraction and video distractionGroup A: Videogame distraction during extraction procedure |
| Group B | Experimental | Behavioral: Video game distraction and video distractionGroup B: Video distraction during extraction procedure |
| Group C | Active comparator | Behavioral: Video game distraction and video distractiongroup C: Verbatim during extraction procedure |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6-12yrs
- Children requiring simple extraction ( Primary teeth with preshedding mobility)
- Children requiring Infiltration LA only
Key exclusion criteria (3 listed)
- Children below 6 yrs and above 12 yrs
- Children with special health care needs
- Children requiring complicated extraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video game distraction and video distractionvideo game distraction and video distraction will be advocated during the extraction procedure | Behavioural | Group A, Group B, Group C |
Primary outcome
Reduction in fear during the treatment
Time frame: 30 minutes
Fear will be assessed before, during and after the treatment by assessing the participants pulse rate
Reduction in anxiety during the treatment
Time frame: 30 minutes
Anxiety will be assessed by using chotta-bheem chutki anxiety scale before, during and after the treatment
1 secondary outcome
Improvement in Oral health knowledge
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Swarna Kannan, Postgraduate principal investigator
Indira gandhi institute of dental sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video game distraction and video distraction in people with Fear Anxiety, run by Indira Gandhi Institute of Dental Science at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Swarna Kannan (8760833345, dentistswarna@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in fear during the treatment (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017; AzTrials last refreshed its copy on 1 Nov 2026.