Measuring and Evaluating the Changes in Anxiety Levels of Children With Repetitive Sessions of Dental Treatments

Measuring and Evaluating the Changes in Anxiety Levels of Children With Repetitive Sessions of Dental Treatments: A Retrospective Observational Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Dental Anxiety
• Intervention / Treatment: Procedure: Dental treatment

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.

• Study Type: Observational
• Enrollment (Actual): 224

Contacts and Locations

Study Locations

• Turkey
  • Erzincan, Turkey
    • Nurcan Kutluer Karaca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
First Visit; Children who visit dentist at first time	Procedure: Dental treatment; bilateral restorative treatment on the mandibular primary first molars
Second Visit; Children who visit dentist at second time	Procedure: Dental treatment; bilateral restorative treatment on the mandibular primary first molars

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental anxiety	The Modified Corah's Dental Anxiety Scale minimum 5 points maximum 25 points more than 15 points means patient have dental axiety .Higher points mean worse outcome	at the first dental visit, during two weeks
Dental anxiety	The Modified Corah's Dental Anxiety Scale minimum 5 points maximum 25 points more than 15 points means patient have dental axiety .Higher points mean worse outcome	at the second dental visit, during two weeks

Collaborators and Investigators

• Sponsor: Erzincan University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Erzincan Binali Yıldırım U.

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