Handheld Mirror to Improve Child's Behavior During Dental Treatment
NCT ID: NCT02366520
Last Updated: 2022-01-25
Study Results
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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COMPLETED
NA
94 participants
INTERVENTIONAL
2015-05-31
2021-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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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.
No interventions assigned to this group
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.
handheld mirror
The child may see the dental treatments that are conducted in his or her mouth by a handheld mirror.
Interventions
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handheld mirror
The child may see the dental treatments that are conducted in his or her mouth by a handheld mirror.
Eligibility Criteria
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Inclusion Criteria
* Children who need at least two restorative appointments
* Primary caregivers who are fluent in English
Exclusion Criteria
* 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
3 Years
17 Years
ALL
Yes
Sponsors
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Case Western Reserve University
OTHER
Responsible Party
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Masahiro Heima
Assistant Professor
Principal Investigators
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Masahiro Heima, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Locations
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University Hospitals, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Countries
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References
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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.
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.
Milgrom P, Weinstein P, Heaton LJ. Treating fearful dental patients: a patient management handbook. 3rd edn. Seattle, WA: Dental Behavioral Resources, 2009.
Piaget, J: The psychology of the child. New York: Basic Books, 1972
Bandura A: Self-efficacy. San Diego, CA, Academic Press, 1994.
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.
Other Identifiers
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03-14-37
Identifier Type: -
Identifier Source: org_study_id
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