NCT04234737

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

January 13, 2020

Last Update Submit

August 22, 2022

Conditions

Dental Anxiety

Keywords

dental anxietyhypnotherapypediatric dentistry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Visual Analog Scale (VAS)

    during dental treatment

Study Arms (2)

Hypnotherapy

EXPERIMENTAL
Behavioral: Hypnotherapy

Control

NO INTERVENTION

Interventions

HypnotherapyBEHAVIORAL

Hypnotherapy

Hypnotherapy

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Faculty of Dentistry Pediatric Dentistry Department

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Fatih Sengul

    assistant professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 21, 2020

Study Start

September 15, 2019

Primary Completion

February 15, 2020

Study Completion

February 15, 2020

Last Updated

August 23, 2022

Record last verified: 2022-08

Locations

TU(1)