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

Not yet recruiting

• Conditions: Desensitization; Dental Anxiety; Dental Care; Distress, Emotional; Cooperation, Patient

• Registration Number: NCT06620289
• Lead Sponsor: Children's Hospital Colorado

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-25
• Study Start: 2024-09-27
• Study First Submitted QC: 2024-09-27
• Last Update Submitted: 2024-09-27
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frankl Behavioral Rating Scale (FBRS)	From enrollment to the end of study at approximately 3 months.	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).

Secondary Outcome Measures

Name	Time	Method
Pre-Visit Parent Survey	Before desensitization visit.	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.
Repeated Desensitization Visit - Pre-Desensitization Parent Survey	Before repeated (if applicable) desensitization visits.	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.
Sensory Tolerance Checklist	From enrollment to the end of study at approximately 3 months.	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.
The Children's Fear Scale (CFS)	From enrollment to the end of study at approximately 3 months.	Measure fear in children undergoing painful medical procedures. Patients receive a score ranging from 0 (Not scared at all) to 5 (Most scared possible).
Psychosocial Risk Assessment in Pediatrics (PRAP)	From enrollment to the end of study at approximately 3 months.	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.