Dental AnxietyNCT04234737
Efficacy of Hypnotherapy in Children With Dental Anxiety
A study testing Hypnotherapy in people with Dental Anxiety, run by Ataturk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Hypnotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2019to 15 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- initial MCDAS(f) total score > 19
- ICDAS II (international caries detection and assessment score)= 5 for at least one tooth
Who cannot join
- presence of dental pain complaint
- non-obtaining the informed consent form
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Faculty of Dentistry Pediatric Dentistry Department
Erzurum
About this study
Official title: 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).
- Conditions
- Dental Anxiety
- Being tested
- Hypnotherapy
- Keywords
- dental anxiety, hypnotherapy, pediatric dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnotherapyBehavioural
Hypnotherapy
| Study group | Role | What they receive |
|---|---|---|
| Hypnotherapy | Experimental | Not described Receives: Behavioral: Hypnotherapy |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: during dental treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start15 Sep 2019
- Primary completion15 Feb 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Kardes, Ataturk University
- Investigators
- Fatih Sengul, Study director, assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234737
- Sponsor's protocol ID
- 352684
- Status last verified
- Aug 2022
- First submitted
- 13 Jan 2020
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hypnotherapy in Children Aged 8-12 Years Old With Dental Anxiety: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04234737
- Acronym / sponsor ID
- 352684
- Conditions
- Dental Anxiety
- Keywords
- dental anxiety, hypnotherapy, pediatric dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnotherapy | Experimental | Behavioral: Hypnotherapy |
| Control | No intervention | – |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- initial MCDAS(f) total score > 19
- ICDAS II (international caries detection and assessment score)= 5 for at least one tooth
Key exclusion criteria (2 listed)
- presence of dental pain complaint
- non-obtaining the informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnotherapyHypnotherapy | Behavioural | Hypnotherapy |
Primary outcome
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.
1 secondary outcome
Visual Analog Scale (VAS)
Time frame: during dental treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatih Sengul study director
assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotherapy in people with Dental Anxiety, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Children Dental Anxiety Scale Faces version MCDAS(f) (time frame: maximum 1 week after hypnotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.