Handheld Mirror to Improve Child's Behavior During Dental Treatment
Condition: Behavior
Study type: Interventional

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.
    

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
    

Intervention name(s): handheld mirror
Intervention type(s): Device
Intervention description(s): The child may see the dental treatments that are conducted in his or her mouth by a handheld mirror.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Child; Child Behavior; Dental Anxiety/prevention & control; Dental Anxiety/psychology; Cooperative Behavior; Dental Care/psychology*; Humans; Videotape Recording