Evaluation of The Effect of Consecutive Dental Visits on Dental Anxiety of Paediatric Patients

NCT06266156 | Completed

• 1 other identifier: BMU-HTUNC-01
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about in effect of consecutive dental visits on dental anxiety of paediatric patients. The main question\[s\]it aims to answer are:

• Did the anxiety level of pediatric patients decrease in consecutive treatment sessions?
• Were there changes in the physiological parameters related to stress level of pediatric patients in consecutive treatment sessions? Participants will fill out the questionnaire about dental anxiety in each dental treatment sessions before and after dental treatment. Researchers will compare paeditric patients have two caries on mandibular molars to see if changes dental anxiety levels and physiological parameters such as heart rates and oxygen saturations during dental treatments in consecutive dental treatment sessions.

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (10)

• Determination of sample size.

  The significance level for the sample size in the study was regulated to show an effect size of 0.83 with a power of 0.05 and 95%. The number of samples (n) was calculated as 200. However, it was decided that the total number of samples (n) would be 260 with data loss foreseen.

  Before the starting to study

• Inviting participants to the study.

  ASA1 and ASA2 healthy children who 6-9 years old without any learning and physical disabilities, children who don't need to emergency dental applications, children who can speak and understand Turkish, children who have dental caries that involved only dentine and enamel and were included to this study. The Abeer Children Dental Anxiety Scale that including three parts as evaluation of child, dental, cognitive and 19 questions was used as a cognitive scale for this study. All the answers were scored with scale of 1-3. Children who have score of 26 and above were classified as anxious. Heart rate and oxygen saturations of each patient were measured with pulse oximeter.

  Before the starting to study

• Determination of dental anxiety score of participants before dental treatment in first dental session

  All participants completed The Abeer Children Dental Anxiety Scale (ACDAS) before starting treatment.The ACDAS that including three parts as evaluation of child, dental, cognitive and 19 questions was used as a cognitive scale for this study. In the dental part of ACDAS including 13 questions, the children answered these questions using with three types of facial expressions for to show how they felt. All the answers were scored with scale of 1-3. The total scores were ranging between 13 and 39. Children who have score of 26 and above were classified as anxious.

  Before the starting to dental treatment in first session.

• Heart rate measuring in first dental session.

  The heart rate were measured in every 5 minutes during dental procedures. Total dental treatment time 15 minutes.

  Measured at the 5th, 10th and 15th minutes of dental treatment.

• Oxygen saturation measuring in first dental session.

  The oxygen saturation were measured in every 5 minutes during dental procedures. Total dental treatment time 15 minutes.

  Measured at the 5th, 10th and 15th minutes of dental treatment.

• Determination of dental anxiety score of participants after dental treatment in first dental session

  All participants completed the dental anxiety questionnaire after treatment process.

  After the dental treatment in first session.

• Determination of dental anxiety score of participants before dental treatment in second dental session

  All participants completed the dental anxiety questionnaire before starting treatment.

  Before the starting to dental treatment in second session.

• Heart rate measuring in second dental session.

  The heart rate were measured in every 5 minutes during dental procedures. Total dental treatment time 15 minutes.

  Measured at the 5th, 10th and 15th minutes of dental treatment.

• Oxygen saturation measuring in second dental session.

  The oxygen saturation were measured in every 5 minutes during dental procedures. Total dental treatment time 15 minutes.

  Measured at the 5th, 10th and 15th minutes of dental treatment.

• Determination of dental anxiety score of participants after dental treatment in second dental session

  All participants completed the dental anxiety questionnaire after treatment process.

  After the dental treatment in second session.

Study Arms (2)

Firts Dental Visit

Dental anxiety level, heart rate and oxygen saturation of participants in first dental visit.

Behavioral: Score of anxiety questionnaire; Diagnostic Test: Heart rate; Diagnostic Test: Oxygen saturation

Second dental visit

Dental anxiety level, heart rate and oxygen saturation of participants in second dental visit.

Behavioral: Score of anxiety questionnaire; Diagnostic Test: Heart rate; Diagnostic Test: Oxygen saturation

Interventions

Score of anxiety questionnaire BEHAVIORAL

All participants were answered the dental anxiety questionnaire.

Firts Dental Visit; Second dental visit

Heart rate DIAGNOSTIC_TEST

All participants heart rate were measured with finger type pulse oxymeter.

Firts Dental Visit; Second dental visit

Oxygen saturation DIAGNOSTIC_TEST

All participants oxygen saturation were measured with finger type pulse oxymeter.

Firts Dental Visit; Second dental visit

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged 6-9 years who meet the inclusion criteria and needed at least two restorative dental treatments of the mandibular first primary molar were included in the study.

You may qualify if:

• According to American Society of Anaesthesiologists (ASA), ASA1 and ASA2 healthy children who 6-9 years old without any learning and physical disabilities, children who don't need to emergency dental applications, children who can speak and understand Turkish, children who have dental caries that involved only dentine and enamel and were included to this study.

You may not qualify if:

• Children with any disabilities that physical and mental or without parental consent were excluded from this study. In addition to this, children who has a systemic disease with changing the blood pressure, oxygen saturation and heart rate were excluded from this study.

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

Study Sites (1)

Burdur Mehmet Akif Ersoy University Faculty of Dentistry

Burdur, Centrum, 15100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Heart Rate; Oxygen Saturation

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Metabolism

Study Officials

• Hamit Tunç, Ph.D

  Burdur Mehmet Akif Ersoy University Faculty of Dentistry Deparment of Paediatric Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 20, 2024
• Study Start: August 5, 2023
• Primary Completion: November 3, 2023
• Study Completion: December 27, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)