Study of Anxiety Free Experiences at the Dentist
NCT07931131, Not applicable, Recruiting, University of Texas Rio Grande Valley
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Study of Anxiety Free Experiences at the Dentist | ClinicalTrials.gov |
| NCT number | NCT07931131 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 160 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Texas Rio Grande Valley | ClinicalTrials.gov |
| Conditions | Dental Phobia, Dental Anxiety in Children, Dental Fear, Dental Fear and Anxiety | ClinicalTrials.gov |
| Interventions | One-Session Treatment for Dental Phobia (OSTD), Psychoeducation and Relaxation Training (RELAX) | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Dental Phobia Severity From Baseline to 6 Months Post-Treatment | 6 months post-treatment | Dental phobia severity will be assessed using the dental phobia module of the Anxiety Disorders Interview Schedule for Children. Information obtained from parent and child interviews will be used to establish a consensus Clinician Severity Rating (CSR). The primary outcome is the consensus CSR at 6 months post-treatment. Score range is 0 to 8, lower scores indicate less severe dental phobia. Treatment group differences will be evaluated using regression analysis adjusting for baseline CSR and prespecified covariates. | ClinicalTrials.gov |
| Primary | Change in Dental Phobia Severity From Baseline to 12 Months Post-Treatment | 12 months post-treatment | Dental phobia severity will be assessed using the dental phobia module of the Anxiety Disorders Interview Schedule for Children. Parent and child interview information will be used to establish a consensus Clinician Severity Rating (CSR). Score range is 0 to 8, lower scores indicate less severe dental phobia. The 12-month consensus CSR will be compared between treatment groups, adjusting for baseline CSR and prespecified covariates. | ClinicalTrials.gov |
| Primary | Change in Dental Anxiety Symptoms From Baseline to 12 Months Post-Treatment | 1 week, 6 months, and 12 months post-treatment | Dental anxiety symptoms will be assessed using the Modified Child Dental Anxiety Scale (MCDAS) and a modified parent version (MDAS-P) administered to children and parents. Scores will be used to evaluate dental anxiety at 1 week, 6 months, and 12 months post-treatment. Treatment group differences will be evaluated at each follow-up assessment using regression models adjusting for baseline dental anxiety and prespecified covariates. Higher scores indicate greater dental anxiety. | ClinicalTrials.gov |
| Primary | Attainment of Personalized Treatment Goal at 6 Months and 12 Months Post Treatment | 6 months and 12 months post-treatment | Treatment goal attainment will be evaluated using a personalized treatment goal identified by the participant's family. Goal attainment will be classified into three ordered categories: no attainment, partial attainment, and full attainment. Treatment group differences will be evaluated using ordinal regression models. | ClinicalTrials.gov |
| Primary | Attendance at Recommended Dental Cleaning Appointment | 6 months and 12 months post-treatment | Compliance with dental health treatment recommendations will be assessed by determining whether the participant attended a recommended dental cleaning appointment. Attendance will be recorded as a binary outcome (attended or did not attend). Treatment group differences will be evaluated at the 6-month and 12-month follow-up assessments. | ClinicalTrials.gov |
| Secondary | Implicit Associations With Dental Stimuli Assessed by the Affect Misattribution Procedure (AMP) | Baseline (within 14 days before treatment), Treatment (Day 0), 1 week post-treatment, and 6 months post-treatment | Implicit associations with dental-related stimuli will be assessed using the Affect Misattribution Procedure (AMP). AMP performance will be examined as an indicator of inhibitory learning and evaluated as a potential mediator of treatment outcomes. The measure will be assessed before treatment and at subsequent assessment points to examine treatment-related changes in automatic affective responses to dental stimuli. | ClinicalTrials.gov |
| Secondary | Change in Outcome Expectancy Violation from Baseline to 6 Months Post-Treatment | Baseline (within 14 days before treatment), Treatment (Day 0), 1 week post-treatment, and 6 months post-treatment | Beliefs about potential harm associated with dental treatment will be assessed using the Harm Beliefs component of the Harm Beliefs and Coping Efficacy Interview. Changes in harm beliefs will be evaluated as an indicator of outcome expectancy violation and examined as a potential mediator of treatment outcomes. Perceived Likelihood (Probability): Rating how certain the participant is that a worst-case scenario will happen (from 0 Not Going to Happen to 8 Definitely Going to Happen). Perceived Severity (Impact): Rating the magnitude of the anticipated danger (from 0 Not Bad at All to 8 Very, Very Bad). | ClinicalTrials.gov |
| Other | Parent-Reported Treatment Satisfaction | 1 week, 6 months, and 12 months post-treatment | Parent satisfaction with the assigned treatment will be assessed using the parent version of the Treatment Satisfaction Survey. Scores will be compared between OSTD and RELAX at each follow-up assessment to evaluate parent-reported treatment satisfaction. Scores range from 12-60 with higher scores indicating more satisfaction. | ClinicalTrials.gov |
| Other | Child-Reported Treatment Satisfaction | 1 week, 6 months, and 12 months post-treatment | Child satisfaction with the assigned treatment will be assessed using the child version of the Treatment Satisfaction Survey. Scores will be compared between OSTD and RELAX at each follow-up assessment to evaluate child-reported treatment satisfaction. Scores range from 12-60 with higher scores indicating more satisfaction. | ClinicalTrials.gov |
| Other | Interventionist-Reported Treatment Satisfaction | Within 6 months of completion of treatment delivery for all study participants | Interventionists will complete the Acceptability of Intervention Measure (AIM) to evaluate their perceptions of treatment acceptability. Scores will be compared between OST-D and RELAX to assess differences in perceived acceptability. Interventionists will complete the Feasibility of Intervention Measure (FIM) to evaluate their perceptions of the feasibility of delivering the treatment. Scores will be compared between OST-D and RELAX to assess differences in perceived treatment feasibility. Interventionists will complete the Intervention Appropriateness Measure (IAM) to evaluate their perceptions of the appropriateness of the treatment for youth with dental phobia. Scores will be compared between OST-D and RELAX. Scores range from 4-20 with higher scores indicating greater acceptability, feasibility and appropriateness for each respective measure. | ClinicalTrials.gov |
| Other | Treatment Fidelity and Interventionist Competence | Treatment (Day 0) | Treatment fidelity and interventionist competence will be assessed using the study-specific Fidelity and Competence Coding Form. Selected treatment sessions will be evaluated to assess adherence to the assigned intervention protocol and competence in treatment delivery. 25% of sessions in each condition will be coded for fidelity and competence. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Affect Misattribution Task | Secondary outcome | ConductCognition |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.