BehaviorNCT02366520
Handheld Mirror to Improve Child's Behavior During Dental Treatment
A study testing handheld mirror in people with Behavior, run by Case Western Reserve University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior
- What is being tested?
- handheld mirror
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
About this study
Official title: 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.
Read the 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:
- Subject characteristic analysis
- Comparison of variables of behavior between study group and control group after controlling for the subject's characteristics and dental treatment procedures
- Conditions
- Behavior
- Being tested
- handheld mirror
- Keywords
- Child, Child Behavior, Dental Anxiety/prevention & control, Dental Anxiety/psychology, Cooperative Behavior, Dental Care/psychology*, Humans, Videotape Recording
- Medical subject headings
- Behavior, Child Behavior, Cooperative Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
handheld mirrorDevice
The child may see the dental treatments that are conducted in his or her mouth by a handheld mirror.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: handheld mirror |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Frankle's cooperative behavior scale (Definitely negative, Negative, Positive, and Definitely positive) is used to assess child's cooperative behavior during dental treatment.
Measured: Child's cooperative behavior will be measured for the duration of dental treatment (up to 1 hour).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masahiro Heima, Case Western Reserve University
- Investigators
- Masahiro Heima, DDS, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366520
- Sponsor's protocol ID
- 03-14-37
- Status last verified
- Jan 2022
- First submitted
- 9 Feb 2015
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 6333311Armfield 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.
PubMed 24320894Milgrom 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Handheld Mirror to Improve Child's Behavior During Dental Treatment
- ClinicalTrials.gov ID
- NCT02366520
- Acronym / sponsor ID
- 03-14-37
- Conditions
- Behavior
- Keywords
- Child, Child Behavior, Dental Anxiety/prevention & control, Dental Anxiety/psychology, Cooperative Behavior, Dental Care/psychology*, Humans, Videotape Recording
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Apr 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Subject characteristic analysis
- Comparison of variables of behavior between study group and control group after controlling for the subject's characteristics and dental treatment procedures
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: handheld mirrorThe 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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| handheld mirrorThe child may see the dental treatments that are conducted in his or her mouth by a handheld mirror. | Device | intervention visit |
Primary outcome
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.
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Background: PubMed 6333311Thrash 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.
- Background: PubMed 24320894Armfield 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.
- BackgroundMilgrom P, Weinstein P, Heaton LJ. Treating fearful dental patients: a patient management handbook. 3rd edn. Seattle, WA: Dental Behavioral Resources, 2009.
- BackgroundPiaget, J: The psychology of the child. New York: Basic Books, 1972
- BackgroundBandura A: Self-efficacy. San Diego, CA, Academic Press, 1994.
- BackgroundGlanz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masahiro Heima, DDS, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing handheld mirror in people with Behavior, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02366520, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.