Efficacy of Hypnotherapy in Children With Dental Anxiety

August 22, 2022 updated by: Elif Kardes, Ataturk University

Efficacy of Hypnotherapy in Children Aged 8-12 Years Old With Dental Anxiety: A Randomized Clinical Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey
        • Ataturk University Faculty of Dentistry Pediatric Dentistry Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Hypnotherapy
Behavioral: Hypnotherapy
Hypnotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
maximum 1 week after hypnotherapy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during dental treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Study Director: Fatih Sengul, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 15, 2019

Primary Completion (ACTUAL)

February 15, 2020

Study Completion (ACTUAL)

February 15, 2020

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (ACTUAL)

January 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 352684

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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