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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04234737
Other study ID # 352684
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2019
Est. completion date February 15, 2020

Study information

Verified date August 2022
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 15, 2020
Est. primary completion date February 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 12 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Hypnotherapy
Hypnotherapy

Locations

Country Name City State
Turkey Ataturk University Faculty of Dentistry Pediatric Dentistry Department Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Children Dental Anxiety Scale Faces version MCDAS(f) 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. maximum 1 week after hypnotherapy.
Secondary Visual Analog Scale (VAS) 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. during dental treatment
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