ClinicalTrials.gg
CompletedNCT04234737Updated Aug 23, 2022

Efficacy of Hypnotherapy in Children With Dental Anxiety

An interventional study of Hypnotherapy in Dental Anxiety, sponsored by Ataturk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-23.

Sponsored by Ataturk University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2019, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
8 Years to 12 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Dental Anxiety

Keywords

  • dental anxiety
  • hypnotherapy
  • pediatric dentistry
03

In context

Lead sponsor

Ataturk University is the lead sponsor of 454 studies on the registry; 123 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Hypnotherapy

    Behavioral: Hypnotherapy

  • No intervention
    Control

Interventions

  • BehavioralHypnotherapy

    Hypnotherapy

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What researchers measure

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.

    Time frame: maximum 1 week after hypnotherapy.

Secondary outcomes

  1. 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.

    Time frame: during dental treatment

07

Study locations

1 site
  • Ataturk University Faculty of Dentistry Pediatric Dentistry Department
    Erzurum, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2019 to primary completion in Feb 2020, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 13, 2020
First posted
Jan 21, 2020
StartActual
Sep 15, 2019
Primary completionActual
Feb 15, 2020
CompletionActual
Feb 15, 2020
Last update
Aug 23, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04234737
Lead sponsor
Ataturk University
Responsible party
Elif Kardes (Principal Investigator, Ataturk University) — Principal investigator
First posted
Jan 21, 2020
Start date
Sep 15, 2019
Primary completion
Feb 15, 2020
Completion
Feb 15, 2020
Last update
Aug 23, 2022

Study contacts

Fatih Sengul
study director · assistant professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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