UMIN-ICDS Clinical Trial

Public title

Virtual Reality Dental Hypnosis for Dental Anxiety: EEG and Salivary Cortisol Responses

Acronym

VRDH

Scientific Title

Neurophysiological and Neuroendocrine Responses Following Virtual Reality Dental Hypnosis in Dental Patients: An Exploratory Quasi Experimental Study

Scientific Title:Acronym

VRDH EEG Study

Region

Asia(except Japan)

Condition

Dental Anxiety During Tooth Extraction

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate short term neurophysiological and neuroendocrine responses following a single session of Virtual Reality Dental Hypnosis (VRDH) in dental patients with moderate dental anxiety undergoing tooth extraction, using electroencephalography (EEG) spectral power and salivary cortisol as objective biomarkers.

Basic objectives2

Others

Basic objectives -Others

Mechanistic and physiological response assessment

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Change in theta band EEG spectral power between baseline (before VRDH intervention) and post intervention assessment immediately after completion of the tooth extraction procedure and VRDH exposure (approximately 40 minutes after baseline).

Key secondary outcomes

1. Change in salivary cortisol concentration between baseline collection (09:00) and post intervention collection immediately after tooth extraction (approximately 09:40-09:42).

2. Changes in delta, alpha, and beta EEG spectral power between baseline and post intervention assessments.

3. Correlation between changes in EEG spectral power (Delta EEG) and changes in salivary cortisol concentration (Delta salivary cortisol) following VRDH intervention.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Single-arm intervention. Participants receive a standardized Virtual Reality Dental Hypnosis (VRDH) session delivered through a custom virtual reality headset. The intervention consists of a 10-minute prerecorded audiovisual hypnodontic program combining natural landscape scenes and verbal hypnotic suggestions. After completion of the initial session, the audiovisual content is automatically replayed throughout the tooth extraction procedure for approximately 30 minutes. Total VRDH exposure is approximately 40 minutes. EEG is recorded continuously and salivary cortisol is collected before and after the intervention.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

58

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Active-duty Indonesian Navy personnel aged 20 to 58 years.
2. Scheduled to undergo routine tooth extraction.
3. Moderate dental anxiety defined as a Modified Dental Anxiety Scale (MDAS) score of 9 to 14.
4. Presence of teeth indicated for routine extraction without severe periodontal abnormalities.
5. Able and willing to provide written informed consent.

Key exclusion criteria

1. Severe dental phobia.
2. Pregnancy, oral contraceptive use, or menstruation at the time of saliva collection.
3. History of systemic, endocrine, metabolic, hematological, neurological, or psychiatric disorders.
4. Use of corticosteroids, hormonal therapy, inhaled corticosteroids, or medications affecting salivary gland function.
5. Xerostomia.
6. Smoking, alcohol abuse, or substance abuse.
7. Psychological or psychiatric conditions that could interfere with study participation or physiological measurements.

Target sample size

11

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

Jl. Ir. Soekarno KM 21, Sumedang 45363, West Java, Indonesia

TEL

0222504985

Email

gilang.yubiliana@unpad.ac.id

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

Jl. Raya Bandung Sumedang KM.21

TEL

0222504985

Homepage URL

https://www.fkg.unpad.ac.id

Email

gilang.yubiliana@unpad.ac.id

Institute

Faculty of Dentistry, Universitas Padjadjaran

Institute

Department

Personal name

Gilang Yubiliana

Organization

Universitas Padjadjaran

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Indonesia

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Dr. Mintohardjo Naval Hospital

Address

Jl. Bendungan Hilir No.17, Jakarta Pusat, Indonesia

Tel

0215703081

Email

rsalminto@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Dr. Mintohardjo Hospital(Jakarta)

Date of disclosure of the study information

2026

Year

08

Month

14

Day

URL releasing protocol

Not available

Publication of results

Unpublished

URL related to results and publications

Not available

Number of participants that the trial has enrolled

11

Results

Eleven participants completed the study. Virtual Reality Dental Hypnosis was associated with significant increases in theta EEG spectral power in frontal and occipital regions after the intervention. Salivary cortisol concentrations showed a decreasing trend following the intervention. Significant associations were observed between changes in EEG activity and salivary cortisol levels.

Results date posted

2026

Year

08

Month

14

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Eleven active-duty Indonesian Navy personnel aged 20 to 58 years with moderate dental anxiety (Modified Dental Anxiety Scale score 9 to 14) scheduled for routine tooth extraction were enrolled.

Participant flow

Eleven participants were screened and enrolled. All participants received the intervention and completed EEG and salivary cortisol assessments. No participants were lost to follow-up.

Adverse events

No serious adverse events related to the intervention were reported.

Outcome measures

Primary outcome:
Change in EEG spectral power between baseline and post-intervention assessments.

Secondary outcomes:
Change in salivary cortisol concentration and correlation between EEG spectral power changes and salivary cortisol changes.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2023

Year

03

Month

01

Day

Date of IRB

2023

Year

04

Month

01

Day

Anticipated trial start date

2023

Year

06

Month

01

Day

Last follow-up date

2023

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study was retrospectively registered after completion of participant recruitment, data collection, and analysis. The study was conducted between June and July 2023 following ethics approval from the Ethics Committee of Dr. Mintohardjo Naval Hospital (Approval No. B/21/EC/LKS/IV/2023).

Registered date

2026

Year

08

Month

14

Day

Last modified on

2026

Year

08

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071627