Clinical trial NCT05571423: The Impact of Medical Play in the Dental Clinic Setting on the Cooperation of Neurotypical Patients
Official title: The Impact of Medical Play in the Dental Clinic Setting on the Cooperation of Neurotypical Patients at Children's Hospital Colorado Dental Center
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Phobia
Dental Anxiety
Oral Aversion
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized clinical controlled trial
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to investigate the efficacy of medical play in the dental setting to improve the behaviors and cooperation of neurotypical patients during dental visits.

The specific aims of the study are as follows:

1. To evaluate differences in behaviors and cooperation levels of subjects utilizing medical play before a routine dental exam visit in comparison to those undergoing a routine dental exam visit without use of medical play.
2. To evaluate whether subjects who have a dental exam visit, with or without use of medical play, show improved behaviors and improved completion of components of the dental exam compared to their previous routine dental visit.
3. To evaluate provider perceptions of the behavior and cooperation of children using medical play before dental exam visits compared to dental exam visits without medical play.
4. To evaluate caregiver perceptions of the behavior and cooperation of children using medical play before dental exam visits compared to dental exam visits without medical play.
5. To evaluate patient perceptions of the dental exam, visit when medical play is used in comparison to dental exam visits without medical play.

The hypotheses are as follows:

1. Subjects will have increased positive behaviors and improved cooperation during dental exam visits when medical play is utilized beforehand.
2. Providers will report improved behavior and cooperation from patients when medical play is utilized beforehand.
3. Parents will report improved behavior and cooperation from their children and report greater satisfaction with the dental visit when medical play is utilized beforehand.
4. Patients will report experiencing less anxiety, via the Modified Child Dental Anxiety Scale - Faces Version (MCDAS-f) after appointments in which medical play is utilized.

Detailed description: The purpose of this study is to investigate the efficacy of medical play to improve the behaviors and cooperation of patients during routine dental exam visits at Children's Hospital Colorado Dental Center through a prospective, randomized controlled trial. The specific aims of this study are to: (1) evaluate differences in behaviors and cooperation levels of subjects utilizing medical play during routine dental exam visits in comparison to those undergoing a routine dental exam visit without use of medical play; (2) evaluate whether subjects who have a dental exam visit, with or without use of medical play, show improved behaviors and improved completion of components of the dental exam compared to their previous routine dental visit; (3) evaluate provider perceptions of the behavior and cooperation of children using medical play during dental exam visits compared to dental exam visits without medical play; (4) evaluate caregiver perceptions of the behavior and cooperation of children using medical play during dental exam visits compared to dental exam visits without medical play; and (5) evaluate patient perceptions of the dental exam visit when medical play is used in comparison to dental exam visits without medical play. To investigate these specific aims, this study will involve recruiting up to 100 neurotypical patients, ages 5-10 years old, who will be seen for their dental exam visits who were previously identified by providers using the Frankl Behavior Rating Scale as Frankl 1 and Frankl 2. Subjects meeting including criteria were screened and offered participating in the study using a telephonic script. Patients agreeing for participation were screened for inclusion and exclusion criteria when they report for routine dental exam and cleaning using pre-screening consent script. Study information, patient rights including voluntary participation and withdrawal of consent without consequences will be provided and informed consent or assent will be collected. The recruited subjects will be randomly divided into two groups so that one group of participants will engage in medical play before the dental exam visit and the other group will be engaged to routine play (coloring exercise) before their dental exam visit. The provider will be blinded to whether the intervention (medical or routine play) before the dental exam visit. The caregivers will complete Dental Behavior Assessment survey before while post-visit survey after the visit to help assess their perceptions of their child's behaviors before and after the visit, respectively. The subjects will also rate their perceived well-being before and after the dental visit using the Modified Child Dental Anxiety Scale - Faces Version. The provider will record patient behavior using a Frankl behavior rating scale and levels of cooperation (which components of the dental exam were completed without coaxing beyond two minutes).

Eligibility criteria: Inclusion Criteria:

* Previously identified as Frankl 1 or Frankl 2 per the electronic dental record during dental exam visits (Epic)
* Child subject is neurotypical
* Patient of record at Children's Hospital Colorado Dental Center
* Child subject is 5-10 years of age
* Caregiver must be the child's legal guardian

Exclusion Criteria:

* Previously identified as Frankl 3 or Frankl 4 per the electronic dental record during dental exam visits (Epic)
* Children who have not previously received care at the Children's Hospital Colorado Dental Center
* Children that have a diagnosis of Autism or other neurologically atypical diagnosis
* Children not in the age range of 5-10 years
* Adult in attendance to dental visit with child is not the legal guardian

Primary outcomes:
measure: Behavior as measured by Frankl score
timeFrame: baseline (post-intervention)
measure: Completion of Components of dental examination
timeFrame: baseline (post-intervention)
Secondary outcomes:
measure: Pre-intervention parental perceptions about their child's behavior
timeFrame: baseline (pre-intervention), post-intervention (immediately after dental visit)
measure: Patient perception before and after dental visit
timeFrame: baseline (pre-intervention), post-intervention (immediately after dental visit)
measure: Post-intervention parental perceptions about their child's behavior
timeFrame: baseline (pre-intervention), post-intervention (immediately after dental visit)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital of Colorado Health Pavilion-Dental Clinic
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Chaitanya P Puranik, BDS,MS,PhD
role: PRINCIPAL_INVESTIGATOR
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