Efficacy of Hypnotherapy in Children With Dental Anxiety

Overview

Dental anxiety is a common problem among the children. The aim of this study is to evaluate the efficacy of hypnotherapy in children with dental anxiety. The participants will be randomized in a 1:1 ratio to hypnotherapy or control group. The outcome measures will be Modified Children Dental Anxiety Scale-faces version(MCDAS(f)) and Visual Analogue Scale(VAS).

Full Title of Study: “Efficacy of Hypnotherapy in Children Aged 8-12 Years Old With Dental Anxiety: A Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 15, 2020

Interventions

  • Behavioral: Hypnotherapy
    • Hypnotherapy

Arms, Groups and Cohorts

  • Experimental: Hypnotherapy
  • No Intervention: Control

Clinical Trial Outcome Measures

Primary Measures

  • Modified Children Dental Anxiety Scale Faces version MCDAS(f)
    • Time Frame: maximum 1 week after hypnotherapy.
    • Modified Children Dental Anxiety Scale is a self-reported measurement and consists of 8 questions with 5 pictorial answers for each question. Total score ranges from 8 to 40, with higher scores higher dental anxiety.

Secondary Measures

  • Visual Analog Scale (VAS)
    • Time Frame: during dental treatment
    • Visual Analog Scale was used to evaluate the dental anxiety in six stages of dental treatment. The scores range from 0 to 10, with higher scores higher dental anxiety.

Participating in This Clinical Trial

Inclusion Criteria

  • initial MCDAS(f) total score > 19
  • ICDAS II (international caries detection and assessment score)= 5 for at least one tooth

Exclusion Criteria

  • presence of dental pain complaint
  • non-obtaining the informed consent form

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ataturk University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Elif Kardes, Principal Investigator – Ataturk University
  • Overall Official(s)
    • Fatih Sengul, Study Director, assistant professor

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