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

August 9, 2017 updated by: Swarna Kannan, Indira Gandhi Institute of Dental Science

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • India
    • Pondicherry
      • Puducherry, Pondicherry, India

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Group A
Group A: Videogame distraction during extraction procedure
Behavioral: Video game distraction and video distraction
video game distraction and video distraction will be advocated during the extraction procedure
EXPERIMENTAL: Group B
Group B: Video distraction during extraction procedure
Behavioral: Video game distraction and video distraction
video game distraction and video distraction will be advocated during the extraction procedure
ACTIVE_COMPARATOR: Group C
group C: Verbatim during extraction procedure
Behavioral: Video game distraction and video distraction
video game distraction and video distraction will be advocated during the extraction procedure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
30 minutes
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
30 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvement in Oral health knowledge
Time Frame: 1 week
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
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indira Gandhi Institute of Dental Science

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Swarna Kannan, Postgraduate, Indira gandhi institute of dental sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IGIDSIRB2016NDP27PGSKPPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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