Back to resultsEfficacy of Hypnotherapy in Children With Dental Anxiety
Primary Purpose
Dental Anxiety
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hypnotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Dental Anxiety focused on measuring dental anxiety, hypnotherapy, pediatric dentistry
Eligibility Criteria
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
Sites / Locations
- Ataturk University Faculty of Dentistry Pediatric Dentistry Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hypnotherapy
Control
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04234737
Brief Title
Efficacy of Hypnotherapy in Children With Dental Anxiety
Official Title
Efficacy of Hypnotherapy in Children Aged 8-12 Years Old With Dental Anxiety: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
February 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety
Keywords
dental anxiety, hypnotherapy, pediatric dentistry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypnotherapy
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Hypnotherapy
Intervention Description
Hypnotherapy
Primary Outcome Measure Information:
Title
Modified Children Dental Anxiety Scale Faces version MCDAS(f)
Description
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.
Time Frame
maximum 1 week after hypnotherapy.
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
during dental treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatih Sengul
Organizational Affiliation
assistant professor
Official's Role
Study Director
Facility Information:
Facility Name
Ataturk University Faculty of Dentistry Pediatric Dentistry Department
City
Erzurum
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy of Hypnotherapy in Children With Dental Anxiety
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