Impact of Dental Desensitization Facilitated by a Child Life Specialist Distress and Cooperation

The Impact of Dental Desensitization Visits Facilitated by a Child Life Specialist on Pediatric Patients' Distress and Cooperation

The aim of this study is to evaluate whether dental desensitization visits facilitated by a Certified Child Life Specialist (CCLS) significantly impact pediatric patients' distress and cooperation levels from the start of desensitization visit(s) to end of the desensitization visit(s), end of desensitization visit to start of subsequent hygiene appointment, and end of hygiene appointment.

Study Overview

• Status: Enrolling by invitation
• Conditions: Dental Anxiety; Distress, Emotional; Desensitization; Dental Care; Cooperation, Patient
• Intervention / Treatment: Behavioral: Dental Desensitization Clinic

• Study Type: Observational
• Enrollment (Estimated): 59

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients and their parents scheduled in the dental center at Children's Hospital Colorado Health Pavillion referred to a child life specialist-facilitated desensitization clinic will be recruited to the study.

Description

Inclusion Criteria:

• Patients and parents of patients aged 2-25 years who have been referred to the desensitization clinic.
• Patients who meet with a CCLS for dental desensitization.

Exclusion Criteria:

• Patients younger than 2 years old and older than 25 years old.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frankl Behavioral Rating Scale (FBRS)	The FBRS is widely used in pediatric dentistry to evaluate patient behavior. FBRS consists of four behavior categories ranging from "definitely positive" to "definitely negative," with higher scores indicating more cooperation. The rating is assigned by the treating pediatric provider and recorded in the patient's medical record at the end of the visit. Participants achieve a scored on a scale ranging from 1 (definitely negative) to 4 (definitely positive).	From enrollment to the end of study at approximately 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-Visit Parent Survey	Parents/caregivers will be asked to fill out a questionnaire before and after the desensitization visit and after the subsequent hygiene appointment. Questions will relate to previous dental experience, previous visit Sensory Tolerance Checklist and the parent's perception of visit success.	Before desensitization visit.
Repeated Desensitization Visit - Pre-Desensitization Parent Survey	If a patient requires more than one dental desensitization visit during the study period, the research team will collect data during subsequent desensitization visits. This survey is a modified and shortened version of the "Pre-Visit Parent Survey" and aims to assess if there have been any changes to the child's developmental diagnoses as well as track how many desensitization visits the patient has had.	Before repeated (if applicable) desensitization visits.
Sensory Tolerance Checklist	Tolerance is operationalized as allowing dental instrument(s) to touch a patient for 1-2 seconds without resisting or exhibiting distress. Three attempts will be made for each step on the checklist before being identified as incomplete. This checklist will be completed by the CCLS and the clinical research coordinator (CRC) for interrater reliability during the desensitization visit.	From enrollment to the end of study at approximately 3 months.
The Children's Fear Scale (CFS)	Measure fear in children undergoing painful medical procedures. Patients receive a score ranging from 0 (Not scared at all) to 5 (Most scared possible).	From enrollment to the end of study at approximately 3 months.
Psychosocial Risk Assessment in Pediatrics (PRAP)	The PRAP assesses pediatric patients by evaluating which patients are at risk of experiencing elevated distress during their health care encounters. Children are scored on a cumulative risk score from 0 (low risk) to 24 (high risk). Scores are categorized into low (0-7 points), medium (8-14 points), and high (15-24) risk levels.	From enrollment to the end of study at approximately 3 months.

Collaborators and Investigators

• Sponsor: Children's Hospital Colorado

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Patient Compliance
• Other Study ID Numbers: 24-0196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No