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

NCT ID: NCT03247959

Last Updated: 2017-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-03

Study Completion Date

2018-07-31

Brief Summary

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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

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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

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Fear Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A

Group A: Videogame distraction during extraction procedure

Group Type EXPERIMENTAL

Video game distraction and video distraction

Intervention Type BEHAVIORAL

video game distraction and video distraction will be advocated during the extraction procedure

Group B

Group B: Video distraction during extraction procedure

Group Type EXPERIMENTAL

Video game distraction and video distraction

Intervention Type BEHAVIORAL

video game distraction and video distraction will be advocated during the extraction procedure

Group C

group C: Verbatim during extraction procedure

Group Type ACTIVE_COMPARATOR

Video game distraction and video distraction

Intervention Type BEHAVIORAL

video game distraction and video distraction will be advocated during the extraction procedure

Interventions

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Video game distraction and video distraction

video game distraction and video distraction will be advocated during the extraction procedure

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Children aged 6-12yrs
2. Children requiring simple extraction ( Primary teeth with preshedding mobility)
3. Children requiring Infiltration LA only

Exclusion Criteria

1. Children below 6 yrs and above 12 yrs
2. Children with special health care needs
3. Children requiring complicated extraction
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indira Gandhi Institute of Dental Science

OTHER

Sponsor Role lead

Responsible Party

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Swarna Kannan

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Swarna Kannan, Postgraduate

Role: PRINCIPAL_INVESTIGATOR

Indira gandhi institute of dental sciences

Locations

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Swarna

Puducherry, Puducherry, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Swarna Kannan

Role: CONTACT

8760833345

kayalvizhi Gurusamy, MDS

Role: CONTACT

9886120559

Facility Contacts

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Swarna kannan, postgraduate

Role: primary

8760833345

Kayalvizhi Gurusamy, MDS

Role: backup

9886120559

Other Identifiers

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IGIDSIRB2016NDP27PGSKPPD

Identifier Type: -

Identifier Source: org_study_id

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