Handheld Mirror to Improve Child's Behavior During Dental Treatment

January 8, 2022 updated by: Masahiro Heima, Case Western Reserve University

Using a Handheld Mirror to Improve Child's Behavior During Dental Treatment

The purpose of this study is to determine whether a handheld mirror helps to reduce child behavior problems during dental treatment. It will be tested by randomized crossover design. Child participants will receive dental treatment under two conditions: during one of the treatment days the child will be given a handheld mirror; another treatment will be done without the child having the mirror. Each condition will be assign on separate days, and the day, which the child has the mirror, will be assigned by chance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants, including 3-17 years old children and primary caregivers as well as pediatric dentists and dental assistants, will be recruited at the Irving and Jeanne Tapper Pediatric Dental Center at University Hospitals Rainbow Babies & Children's Hospital in Cleveland, Ohio. Instructional sessions will provide proper use of a handheld mirror to pediatric dentists and dental assistants.

On the first dental appointment:

After obtain consent and assent form, the caregiver will be asked to complete a questionnaire, "Questionnaire for Caregiver", which includes questions to assess the caregiver's dental anxiety level, the caregiver's perception of the child's dental fear level, and collect characteristic information such as age and gender. The child will also be asked to complete a questionnaire; a 3-6 years old child will complete the questionnaire "Questionnaire for Child 3-6," which includes the face image scale to measure his/her level of dental anxiety; a 7-17 years old child will complete the questionnaire "Questionnaire for Child 7-17," which includes the face image scale and the Dental Subscale of the Children's Fear Survey Schedule (CFSS-DS) to measure his/her level of dental anxiety.

The child will then be randomly assigned to either Group 1, in which the child will receive the dental treatment with the mirror at the first visit and receive dental treatment without the mirror at the second visit, or Group 2, which will receive dental treatment without the mirror on the first visit and receive dental treatment with the mirror on the second visit. The child's, dentists' and dental assistants' behavior will be video recorded during treatment. The dentist will guide the child to see the inside of his or her mouth during the dental care procedure. At the end of appointment, children who are 7 -17 years old will be asked the ease of receiving dental treatment by a 5 point Likert scale.

On the second appointment, the same procedure will occur including the questionnaire and video recording.

However, the child who has been assigned to Group 1 will not have a mirror and the child who has been assigned to Group 2 will have a mirror during dental procedures.

The questionnaire and video files will be stored in a secure location which protected passwords.

Behavioral data will be coded, counted and assessed.

The child's chart will be reviewed to find the child's temperament and to count the total number of primary teeth, permanent teeth, decayed, filled, and extracted teeth due to dental caries at the examination visit.

Data analyses:

The impact of the mirror will be measured by the following variables and analyzed using the children's behavior after controlling for the children's characteristic and procedures:

  1. Subject characteristic analysis
  2. Comparison of variables of behavior between study group and control group after controlling for the subject's characteristics and dental treatment procedures

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • 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 Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals, Rainbow Babies and Children's Hospital

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

Ages Eligible for Study

3 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A dyad of children who are 3-17 years of age and their primary caregiver
  • Children who need at least two restorative appointments
  • Primary caregivers who are fluent in English

Exclusion Criteria:

  • Children who have a visual impairment
  • Children who need protective stabilization to immobilize children's body for treatment
  • Children who are not able to hold the mirror
  • Children who don't have ability to answer the questions

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control visit
The child receives dental treatment without the handheld mirror. The child cannot see the dental treatments that are conducted in his or her mouth.
Experimental: intervention visit
The child receives dental treatment with handheld mirror. The child may see the dental treatments that are conducted in his or her mouth by the handheld mirror.
Device: handheld mirror
The child may see the dental treatments that are conducted in his or her mouth by a handheld mirror.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of instances of child's disruptive behavior defined by the Anxious and Disruptive Behavior Code
Time Frame: Child's disrupted behavior will be measured for the duration of dental treatment (up to 1 hour).
The Anxious and Disruptive Behavior Code which includes head movement, body movement, complaints and crying, and restraints is used to count child's disrupted behavior during dental treatment.
Child's disrupted behavior will be measured for the duration of dental treatment (up to 1 hour).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child's cooperative behavior level assessed by Frankle's Cooperative Behavior Scale
Time Frame: Child's cooperative behavior will be measured for the duration of dental treatment (up to 1 hour).
Frankle's cooperative behavior scale (Definitely negative, Negative, Positive, and Definitely positive) is used to assess child's cooperative behavior during dental treatment.
Child's cooperative behavior will be measured for the duration of dental treatment (up to 1 hour).

Collaborators and Investigators

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

Sponsor

Case Western Reserve University

Investigators

  • Principal Investigator: Masahiro Heima, DDS, PhD, Case Western Reserve University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2015

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

February 18, 2015

First Posted (Estimate)

February 19, 2015

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 8, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 03-14-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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