UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059291 |
|---|---|
| Receipt number | R000067776 |
| Scientific Title | Effectiveness of Virtual Reality Dental Hypnosis in Lowering Dental Anxiety: Brain Wave Analysis Using EEG |
| Date of disclosure of the study information | 2025/10/05 |
| Last modified on | 2025/10/05 09:28:35 |
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Basic information
Public title
Virtual Reality Dental Hypnosis for Reducing Dental Anxiety in Military Patients
Acronym
VRDH
Scientific Title
Effectiveness of Virtual Reality Dental Hypnosis in Lowering Dental Anxiety: Brain Wave Analysis Using EEG
Scientific Title:Acronym
Effectiveness of Virtual Reality Dental Hypnosis in Lowering Dental Anxiety: Brain Wave Analysis Using EEG
Region
| Asia(except Japan) |
Condition
Condition
Dental anxiety (ICD-10 F40.2)
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of Virtual Reality Dental Hypnosis (VRDH) in reducing dental anxiety and modulating brain activity measured by EEG compared with conventional VR distraction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in EEG alpha and theta wave amplitude during and after VRDH intervention compared to control VR (Time frame: baseline, intervention, post-intervention).
Key secondary outcomes
1) Change in Modified Dental Anxiety Scale (MDAS) score (baseline to post-intervention) 2) Change in Galvanic Skin Response (GSR) values (baseline to post-intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
Group 1 received EEG treatment during a Virtual Reality Distraction Hypnosis (VRDH) session. The session was composed of 7 seconds of hypnotic content and 3 seconds of VR presentation.
Interventions/Control_2
Group 2 was given a VR intervention with no hypnotic content, but of equal length.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 58 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Navy soldiers (male or female) who will receive tooth extraction. 2) Aged 20 - 58 years old. 3) Have a tooth that meets the indications for regular extraction in the absence of periodontal abnormalities 4) Have a medium (9-12) or high (13-14) SADT score 5) Willing to be a research subject by signing a letter of consent in the informed consent form.
Key exclusion criteria
1) Patients with dental phobia (SADT > 25) 2) Female patients who are pregnant, using oral contraceptives and in menstrual cycle 3) Patients using inhaled steroids 4) Patients using any medication that can affect the salivary glands (antihypertensive drugs, antidepressant drugs, antipsychotic drugs) 5) Patients with a history of systemic diseases, endocrine and metabolic diseases and blood deficiencies 6) Patients undergoing corticosteroid and hormonal therapy 7) Patients who have habits that can reduce salivary volume, such as smoking. 8) Patients with xerostomia 9) Patients with drug or alcohol abuse 10) Patients with abnormal psychological development
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Gilang |
| Middle name | |
| Last name | Yubiliana |
Organization
Faculty of Dentistry, Universitas Padjadjaran
Division name
Department of Dental Public Health
Zip code
45363
Address
Hegarmanah, Kec. Jatinangor, Kabupaten Sumedang, Jawa Barat 45363
TEL
0222504985
gilang.yubiliana@unpad.ac.id
Public contact
Name of contact person
| 1st name | Gilang |
| Middle name | |
| Last name | Yubilianan |
Organization
Faculty of Dentistry, Universitas Padjadjaran
Division name
Department of Dental Public Health
Zip code
45363
Address
Hegarmanah, Kec. Jatinangor, Kabupaten Sumedang, Jawa Barat 45363
TEL
0222504985
Homepage URL
https://www.fkg.unpad.ac.id
gilang.yubiliana@unpad.ac.id
Sponsor or person
Institute
Padjadjaran University
Institute
Department
Personal name
Gilang Yubiliana
Funding Source
Organization
Padjadjaran University Research Grant (RKDU) from 2023
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Indonesia
Other related organizations
Co-sponsor
RS TNI AL Dr. Mintohardjo, Jakarta; Department of Physics, Universitas Padjadjaran; Department of Computer Science, Universitas Padjadjaran; SeGi University & Colleges, Malaysia;
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Ethics Committee of Dr. Mintohardjo Naval Hospital
Address
Jl. Bendungan Hilir No.17, Central Jakarta, Indonesia
Tel
0215703081
diklat.rsmth@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
RS TNI AL Dr. Mintohardjo, Jakarta, Indonesia
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Ethics Committee of Dr. Mintohardjo Naval Hospital Jakarta (number B/21/EC/LKS/IV/2023).
Publication of results
Unpublished
Result
URL related to results and publications
Ethics Committee of Dr. Mintohardjo Naval Hospital Jakarta number B/21/EC/LKS/IV/2023).
Number of participants that the trial has enrolled
22
Results
Manuscript under internal review, titled Effectiveness of Virtual Reality Dental Hypnosis in Lowering Dental Anxiety: Brain Wave Analysis Using EEG.
Results date posted
| 2025 | Year | 10 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 22 military dental patients aged 20-58 years were enrolled. No statistically significant difference between groups for age, sex, or military rank .
Participant flow
We conducted a parallel-group randomized clinical trial with two intervention groups. A precursor phase involving 65 potential participants was conducted, which aimed to obtain baseline information on the number of patients reporting moderate-to-severe levels of dental anxiety at the TNI-AL Health Service Facilities. Dental anxiety was recorded both objectively through the Galvanic Skin Response (GSR) and subjectively using the Indonesian version of the Modified Dental Anxiety Scale (MDAS). Demographic patient data were collected during this stage, including age, sex, military rank, unit assignment, history of unpleasant dental experiences, and previous tooth extractions. An instrument validation test was also conducted to ensure that all measurement instruments used were reliable and valid. The instruments utilized for screening were the SADT to evaluate anxiety and a modified GSR to track physical signs of anxiety. This phase also showed the dental anxiety levels of the patient population (low to high) who visited the TNI-AL health clinics. Patients whose criteria matched the set criteria were recruited into the study and received comprehensive information about all study phases. Participants who understood and agreed to take part fully were requested to sign a form of informed consent. Of the original 65 subjects, 43 were excluded owing to failure to meet the inclusion and exclusion criteria, resulting in 22 eligible participants. These volunteers (20-58-year-old navy personnel with teeth scheduled for extraction in the absence of periodontal pathology and with moderate-to-high SADT scores (9-14)) were randomly divided into two groups (Group 1 and Group 2, n=11 per group).
Adverse events
None reported during or after intervention.
Outcome measures
Primary outcome: Changes in EEG alpha and theta power during and after intervention. Secondary outcomes: Changes in Modified Dental Anxiety Scale (MDAS) and Galvanic Skin Response (GSR). The VRDH group showed increased alpha/theta power and decreased beta activity with corresponding reductions in MDAS and GSR scores.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 05 | Day |
Last modified on
| 2025 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067776
