An interventional study of Modified Bottom-to-Bottom Comfort Position in Dental Anxiety in Children, Feasibility Studies and Comfort, sponsored by Children's Hospital Colorado. Not yet recruiting at 1 site in United States. Open to participants aged 12 Months to 5 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Children's Hospital Colorado · Not applicable, Interventional, and Supportive care
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.
Children's Hospital Colorado is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Patients and caregivers will utilize a modified bottom-to-bottom comfort position with the guidance of a certified Child Life Specialist during a routine dental hygiene exam.
Other: Modified Bottom-to-Bottom Comfort Position
Patients 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.
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.
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.
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.
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.
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.
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.
Feasibility of Intervention Measure (FIM)
Four-item 5-point Likert scales assessing parental feasibility of the modified comfort hold position.
Time frame: Approximately 30 minutes after starting the dental exam.
Provider Feedback and Acceptability
Provider-reported acceptability, appropriateness, and perceived feasibility of the modified comfort position
Time frame: Approximately 30 minutes after starting the dental exam.
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Children's Hospital Colorado