UMIN-ICDS 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語

英語
Using Virtual Reality to Help Reduce Anxiety Before Oral Surgery

一般向け試験名略称/Acronym

日本語

英語
VR-RELAX

科学的試験名/Scientific Title

日本語

英語
The Effectiveness of Virtual Reality in Reducing Perioperative Anxiety Among Oral Surgery Patients: A Salivary Biomarker and Questionnaire-Based Study

科学的試験名略称/Scientific Title:Acronym

日本語

英語
RELAX-VR
Reducing perioperative anxiety using salivary biomarker analysis and Virtual Reality

試験実施地域/Region

アジア（日本以外）/Asia(except Japan)

対象疾患名/Condition

日本語

英語
Preoperative anxiety in oral surgery patients

疾患区分1/Classification by specialty

口腔外科学/Oral surgery	歯学/Dental medicine

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語

英語
The objective of this study is to evaluate the effectiveness of virtual reality in reducing preoperative anxiety among patients undergoing minor oral surgery. This will be assessed using changes in salivary alpha-amylase and cortisol levels, as well as the Amsterdam Preoperative Anxiety and Information Scale (APAIS)

目的2/Basic objectives2

有効性/Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

探索的/Exploratory

試験の性質2/Trial characteristics_2

説明的/Explanatory

試験のフェーズ/Developmental phase

第Ⅰ相/Phase I

主要アウトカム評価項目/Primary outcomes

日本語

英語
Changes in salivary alpha-amylase, salivary cortisol levels, and APAIS scores from pre- to post-intervention to assess perioperative anxiety reduction.

副次アウトカム評価項目/Key secondary outcomes

日本語

英語
Patient satisfaction score with preoperative experience
Definition: Self-reported satisfaction with the preoperative process, including comfort and clarity of information.
Time point: Immediately after intervention (after VR or control exposure but before surgery).
Instrument: 5-point Likert scale questionnaire (1 = very dissatisfied, 5 = very satisfied).
Change in heart rate as a physiological marker of anxiety
Definition: Difference in heart rate measured before and after intervention.
Time point: Measured immediately before and after VR or control exposure.
Unit: Beats per minute (bpm).
Method: Digital pulse oximeter.
Incidence of adverse events during VR use
Definition: Frequency of nausea, dizziness, or other discomfort during or after VR exposure.
Time point: During and immediately after VR session.
Method: Structured observation checklist and spontaneous reporting.

試験の種類/Study type

介入/Interventional

基本デザイン/Basic design

並行群間比較/Parallel

ランダム化/Randomization

ランダム化/Randomized

ランダム化の単位/Randomization unit

個別/Individual

ブラインド化/Blinding

オープン/Open -no one is blinded

コントロール/Control

無治療対照/No treatment

層別化/Stratification

いいえ/NO

動的割付/Dynamic allocation

いいえ/NO

試験実施施設の考慮/Institution consideration

施設を考慮していない/Institution is not considered as adjustment factor.

ブロック化/Blocking

はい/YES

割付コードを知る方法/Concealment

中央登録/Central registration

群数/No. of arms

2

介入の目的/Purpose of intervention

治療・ケア/Treatment

介入の種類/Type of intervention

行動・習慣/Behavior,custom

介入1/Interventions/Control_1

日本語

英語
Virtual Reality Relaxation
Participants in the intervention group received a 15-minute immersive Virtual Reality (VR) session immediately prior to minor oral surgery under general anesthesia. The VR content featured a relaxing beach environment with calming background sounds. The session was delivered using a head-mounted display (Oculus Go), with the same video and duration used for all participants to ensure standardization.
Duratioin 15 minutes, one-time session

介入2/Interventions/Control_2

日本語

英語
Standard Preoperative Procedure (Control Group)

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

18

歳/years-old

より上/<

年齢（上限）/Age-upper limit

40

歳/years-old

以下/>=

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語

英語
Adults aged 18 to 45 years
Scheduled for elective minor oral surgery under general anesthesia
Able to understand the study procedures and provide informed consent
Able to read and complete the APAIS questionnaire
No prior exposure to virtual reality

除外基準/Key exclusion criteria

日本語

英語
History of psychiatric or neurological disorders
Use of medications affecting stress hormones in the last 7 days (e.g., corticosteroids, anxiolytics)
Systemic diseases that may affect saliva biomarkers (e.g., diabetes, adrenal disorders)
Current or past substance abuse (alcohol, drugs)
Pregnant or breastfeeding
Visual, vestibular, or balance disorders that interfere with VR usage
Allergy to materials used for saliva collection
Unwilling or unable to comply with study procedures

目標参加者数/Target sample size

30

責任研究者/Name of lead principal investigator

日本語

名
ミドルネーム
姓

英語

名	Abel
ミドルネーム	Tasman
姓	Yuza

所属組織/Organization

日本語

英語
Universitas Padjadjaran

所属部署/Division name

日本語

英語
Faculty of Dentistry

郵便番号/Zip code

40132

住所/Address

日本語

英語
Jalan Sekeloa Selatan i Bandung

電話/TEL

62817212232

Email/Email

abel.yuza@unpad.ac.id

試験問い合わせ窓口担当者/Name of contact person

日本語

名
ミドルネーム
姓

英語

名	Arlette
ミドルネーム	Suzy
姓	Setiawan

組織名/Organization

日本語

英語
Universitas Padjadjaran

部署名/Division name

日本語

英語
Faculty of Dentistry

郵便番号/Zip code

40132

住所/Address

日本語

英語
Jl. Sekeloa Selatan I Bandung

電話/TEL

628122092334

試験のホームページURL/Homepage URL

Email/Email

arlette.puspa@unpad.ac.id

機関名/Institute

日本語
その他

英語
Universitas Padjadjaran

機関名/Institute
（機関選択不可の場合）

日本語

部署名/Department

日本語

個人名/Personal name

日本語

英語
Universitas Padjadjaran

機関名/Organization

日本語
その他

英語
Universitas Padjadjaran

機関名/Organization
（機関選択不可の場合）

日本語

組織名/Division

日本語

組織の区分/Category of Funding Organization

地方自治体/Local Government

研究費拠出国/Nationality of Funding Organization

日本語

英語

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語

英語
Research Ethics Committee, Faculty of Dentistry, Universitas Padjadjaran

住所/Address

日本語

英語
Jalan Sekeloa Selatan I

電話/Tel

6222

Email/Email

fkg@unpad.ac.id

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

Rumah Sakit Gigi dan Mulut Unpad

一般公開日（本登録希望日）/Date of disclosure of the study information

2025

年

11

月

10

日

プロトコル掲載URL/URL releasing protocol

試験結果の公開状況/Publication of results

未公表/Unpublished

結果掲載URL/URL related to results and publications

組み入れ参加者数/Number of participants that the trial has enrolled

30

主な結果/Results

日本語

英語
A total of 30 participants were randomized equally into VR and control groups. Both groups showed significant reductions in salivary alpha-amylase and APAIS scores post-intervention. No significant between-group differences were observed in cortisol levels. The VR group showed a larger reduction in anxiety biomarkers and questionnaire scores, suggesting VR may be effective in reducing perioperative anxiety.

主な結果入力日/Results date posted

2025

年

11

月

08

日

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語

英語
A total of 30 participants were enrolled in the study and randomly allocated into the Virtual Reality (VR) group and the control group, with 15 participants in each. Baseline characteristics including age, sex, and educational background were comparable between the two groups, indicating successful randomization.

参加者の流れ/Participant flow

日本語

英語
Out of 45 patients assessed for eligibility, 30 participants met the inclusion criteria and were randomized into two groups: 15 in the Virtual Reality (VR) group and 15 in the control group. All participants received the allocated intervention and completed the study, with no loss to follow-up or discontinuation.

有害事象/Adverse events

日本語

英語
No adverse events or complications were reported in either the Virtual Reality (VR) or control group throughout the study period. All participants completed the intervention without experiencing dizziness, nausea, discomfort, or exacerbation of anxiety symptoms during or after the intervention. The procedure and data collection process were well tolerated by all participants.

評価項目/Outcome measures

日本語

英語
Primary Outcome
Name: Change in preoperative anxiety levels
Measurement Tool: Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Timepoint: Before and after the intervention (immediately after VR exposure and before surgery)
Description: APAIS scores will be compared between the VR intervention group and the control group to determine effectiveness in reducing preoperative anxiety.

Key Secondary Outcomes
Name: Salivary alpha-amylase concentration
Measurement Tool: Saliva test using ELISA method
Timepoint: Before and after VR intervention
Description: Measures sympathetic nervous system activity associated with stress.
Name: Salivary cortisol concentration
Measurement Tool: Saliva test using ELISA method
Timepoint: Before and after VR intervention
Description: Measures hypothalamic-pituitary-adrenal (HPA) axis activity to assess physiological stress response.

個別症例データ共有計画/Plan to share IPD

日本語

英語
Plan to share IPD: No

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語
Justification:
The individual participant data (IPD) will not be shared publicly due to privacy concerns and ethical considerations related to identifiable salivary biomarkers and anxiety questionnaires.

試験進捗状況/Recruitment status

参加者募集終了‐試験継続中/No longer recruiting

プロトコル確定日/Date of protocol fixation

2024

年

12

月

01

日

倫理委員会による承認日/Date of IRB

2023

年

12

月

15

日

登録・組入れ開始（予定）日/Anticipated trial start date

2025

年

01

月

01

日

フォロー終了(予定)日/Last follow-up date

2025

年

07

月

01

日

入力終了(予定)日/Date of closure to data entry

データ固定（予定）日/Date trial data considered complete

解析終了(予定)日/Date analysis concluded

その他関連情報/Other related information

日本語

英語

登録日時/Registered date

2025

年

11

月

08

日

最終更新日/Last modified on

2025

年

11

月

08

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000068285

英語
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068285