NCT05571423

The Impact of Medical Play in the Dental Clinic Setting on the Cooperation of Neurotypical Patients

The Impact of Medical Play in the Dental Clinic Setting on the Cooperation of Neurotypical Patients at Children's Hospital Colorado Dental Center

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Accepted

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).

Conditions

• Dental Phobia
• Dental Anxiety
• Oral Aversion

Interventions

Type	Name	Description
BEHAVIORAL	Medical Play	Study subject will be engage in the medical play.
BEHAVIORAL	Routine Play	Study subject will be engage in the routine play (coloring exercise).

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2022-10-07
• Last updated: 2024-02-01

Locations

1 site across 1 country: United States