Feasibility of a Modified Dental Comfort Position for Pediatric Patients Receiving Dental Exams
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-5
SponsorChildren's Hospital Colorado
About this trial
The goal of this study is to learn if a modified bottom-to-bottom comfort position is a feasible alternative to the traditional knee-to-knee position during dental hygiene examinations for patients aged 12 months to 5 years. In the modified position, the patient sits in their caregiver's lap and reclines their head on the dental chair, allowing for both parental contact and dental provider access to the patient's mouth. This study will also examine the modified position's impact on the patient's distress and cooperation during the exam, parental satisfaction, and provider perception. The main questions are:
Is the modified comfort position a safe and feasible alternative for young children undergoing dental hygiene exams? How does the modified comfort position impact patient completion rate and dental exam duration? How does the modified comfort position impact patient distress and cooperation, parental satisfaction, and provider acceptability?
Participants will:
Utilize the modified comfort position with the guidance of a Certified Child Life Specialist.
Undergo a routine dental hygiene exam. Answer survey questions about parental satisfaction and patient psychological and developmental diagnoses.
Dental providers will answer survey questions about acceptability and feasibility.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 12 months to 5 years
Children attending the CHCO Health Pavilion Dental Clinic for a dental hygiene examination or cleaning visit
Children accompanied by a parent or legal guardian
Disqualifiers
Children requiring sedation for their dental hygiene visit
Children and families' primary language is not English or Spanish
Children requiring medical immobilization (MI) for their hygiene visit
Dental provider is unwilling to utilize modified bottom-to-bottom positioning
Trial design
Design model
Single group
Treatments tested in this trial
Modified Bottom-to-Bottom Comfort Position
Other interventionPatients will sit on their caregiver's lap, facing their caregiver. Patients will recline between their caregiver's legs, so their head rests on the dental chair. Caregivers can hold their child's hands and limit the movement of their child's legs with their forearms. The dental provider can access the child's mouth without needing the child's head to rest in their lap.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Modified Dental Comfort PositionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Completion Rate
A five-item measure that tracks patient completion of steps within a dental hygiene exam. Trained research staff members will observe the dental exam and record the patient's completion of each examination step as: completed, attempted but not completed, patient refused, provider didn't attempt due to behavior, and N/A.
Time frame
Approximately 30 minutes after starting the dental exam.2
Session duration
Total time (in minutes) the child remained in the modified comfort position during the dental examination.
Time frame
Approximately 30 minutes after starting the dental exam.Secondary outcomes
1
Frankl Behavior Rating Scale
Provider-rated child cooperation during the dental examination, categorized via the Frankl scale classification system from 1 (definitely negative) to 4 (definitely positive).
Time frame
Approximately 30 minutes after starting the dental exam.2
FLACC (Face, Legs, Activity, Cry, Consolability) Scale
5-item measures to assess the frequency and intensity of observed distress-related behaviors during the dental examination. A trained research staff member will observe the exam and record each item on a scale from 0 (normal, content, relaxed, etc.) to 2 (kicking, rigid, crying, etc.).
Time frame
Approximately 15 minutes after starting the dental exam.3
Parent Satisfaction
Four-item measure to assess parental satisfaction with the care their child received during their visit. Parents will rate each item on a four-point Likert-like scale ranging from poor to excellent.
Time frame
Approximately 30 minutes after starting the dental exam.4
Acceptability of Intervention Measure (AIM)
Four-item 5-point Likert scales assessing parental acceptability of the modified comfort hold position.
Time frame
Approximately 30 minutes after starting the dental exam.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: