NCT02366520

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

5.9 years

First QC Date

February 9, 2015

Last Update Submit

January 8, 2022

Conditions

Behavior

Keywords

ChildChild BehaviorDental Anxiety/prevention & controlDental Anxiety/psychologyCooperative BehaviorDental Care/psychology*HumansVideotape Recording

Outcome Measures

Primary Outcomes (1)

  • Number of instances of child's disruptive behavior defined by the Anxious and Disruptive Behavior Code

    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 Outcomes (1)

  • Child's cooperative behavior level assessed by Frankle's Cooperative Behavior Scale

    Child's cooperative behavior will be measured for the duration of dental treatment (up to 1 hour).

Study Arms (2)

control visit

NO INTERVENTION

The child receives dental treatment without the handheld mirror. The child cannot see the dental treatments that are conducted in his or her mouth.

intervention visit

EXPERIMENTAL

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

Interventions

handheld mirrorDEVICE

The child may see the dental treatments that are conducted in his or her mouth by a handheld mirror.

intervention visit

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Related Publications (6)

  • Thrash WJ, Russel-Duggan J, Mizes JS. The origin and prevention of dental fears. Clin Prev Dent. 1984 Sep-Oct;6(5):28-32. No abstract available.

    PMID: 6333311BACKGROUND

  • Armfield JM, Heaton LJ. Management of fear and anxiety in the dental clinic: a review. Aust Dent J. 2013 Dec;58(4):390-407; quiz 531. doi: 10.1111/adj.12118.

    PMID: 24320894BACKGROUND

  • Milgrom P, Weinstein P, Heaton LJ. Treating fearful dental patients: a patient management handbook. 3rd edn. Seattle, WA: Dental Behavioral Resources, 2009.

    BACKGROUND

  • Piaget, J: The psychology of the child. New York: Basic Books, 1972

    BACKGROUND

  • Bandura A: Self-efficacy. San Diego, CA, Academic Press, 1994.

    BACKGROUND

  • Glanz K, Rimer BK, Viswanath K: Health behavior and health education: Theory, research, and practice in. San Francisco, John Wiley & Sons, Inc, 2008, p 552 p.

    BACKGROUND

MeSH Terms

Conditions

BehaviorChild BehaviorCooperative Behavior

Condition Hierarchy (Ancestors)

Social Behavior

Study Officials

  • Masahiro Heima, DDS, PhD

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 19, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2021

Study Completion

June 1, 2021

Last Updated

January 25, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)