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Completed

NCT Number: NCT06620289

Impact of Dental Desensitization Facilitated by a Child Life Specialist 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.

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Key information

Conditions

Desensitization Behavior Cooperation, Patient Dental Anxiety Dental Care Distress, Emotional Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

2 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dental Desensitization Clinic

Behavioral

The goal of offering desensitization visits is to reduce the dental anxiety and distress of patients and enhance their cooperation during future appointments. The specifics of the desensitization are individualized to meet the unique needs of each patient based on information provided by the parent/caregiver. A standard desensitization visit involves providing the patient the opportunity to sit in the exam chair; touch the toothbrush and rubber prophy cup, mouth mirror, fluoride applicator brush, air-water syringe tip and saliva ejector tip; gain exposure to the dental lights and sounds commonly experienced in the dental visit; practice opening their mouth; and tolerate toothbrush and rubber prophy cup, mirror, explorer, fluoride applicator brush, air-water syringe, and salvia ejector in the mouth. If the child is unable or unwilling to participate, these activities are modeled on the parent or by the CCLS.

Primary outcomes

  1. Frankl Behavioral Rating Scale (FBRS)

    Time frame: 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 outcomes

  1. Pre-Visit Parent Survey

    Time frame: 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.

  2. Repeated Desensitization Visit - Pre-Desensitization Parent Survey

    Time frame: 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.

  3. Sensory Tolerance Checklist

    Time frame: 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.

  4. The Children's Fear Scale (CFS)

    Time frame: 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).

  5. Psychosocial Risk Assessment in Pediatrics (PRAP)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Colorado

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2024
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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