Clinical trial NCT04967300: Measuring and Evaluating the Changes in Anxiety Levels of Children With Repetitive Sessions of Dental Treatments
Official title: Measuring and Evaluating the Changes in Anxiety Levels of Children With Repetitive Sessions of Dental Treatments: A Retrospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Anxiety
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 224
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 224 children aged 5-8 years who needed at least two restorative dental treatments of the mandibular first primary molar were included in the study. As the inclusion criteria, children with no mental disorders, with no past dental experience, hospitalization or invasive medical treatments, and no pain or symptom in their oral health. All included children and parents had to spoken and understood the Turkish language. Patients with chronic systemic illnesses that may affect the blood pressure or heart rate of a child were excluded from the study. Only children who required multiple-visit treatments were taken into consideration.

Brief summary: Dental anxiety is defined as the fear of terrible events during dental treatment and the loss of control.Anxiety may be related to adaptation of the patient to external factors in environment, so the adaptation of the pediatric patient to the stimuli in the dental environment may affect the level of anxiety.The aim of the this study was to evaluate the relationship between sequential visits in dental treatments and dental anxiety levels of pediatric patients with anxiety scales and physiological measurements.

Detailed description: A total of 224 children aged 5-8 years who needed at least two restorative dental treatment of the mandibular first primary molar were included in the study.

In each sessions the Wong-Baker FACES Pain Rating Scale (W-BFRS) was used to evaluate the dental anxiety before and after the treatment.

The Modified Corah's Dental Anxiety Scale (MDAS) was used as a dental anxiety measurement method.

A portable finger pulse oximeter (Nellcor™ PMN10, Medtronic Corp. MN, USA) was used to measure the heart rate.

Data were statistically analyzed with the help of the Statistical Package for Social Sciences statistical software (SPSS 18.0), considering a 5% significance level. Nonparametric tests were used. Normality assumption was evaluated with the Kolmogorov Smirnov test. The association between two groups was analyzed by Wilcoxon Signed Rank Test.

Eligibility criteria: Inclusion Criteria:

* Children aged 5-8 years
* Children who need at least two restorative dental treatments of the mandibular first primary molar

Exclusion Criteria:

* Chronic systemic illnesses
* Dental experience
* Mental disorders
* Invasive medical treatments
* Hospitalization
* Oral health problems with a painful history

Primary outcomes:
measure: Dental anxiety
timeFrame: at the first dental visit, during two weeks
measure: Dental anxiety
timeFrame: at the second dental visit, during two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Nurcan Kutluer Karaca
Study officials:
References: