Effects of Virtual Reality Content on Anxiety During Third Molar Surgery
2026年9月13日 更新者：İsmail Burak HALAT、Recep Tayyip Erdogan University
A Comparative Evaluation of the Effects of Different Virtual Reality (VR) Content on Patient Anxiety During Impacted Mandibular Third Molar Surgery
This randomized controlled study evaluated whether the content of an immersive virtual reality environment influenced anxiety in adults undergoing surgical removal of an impacted mandibular third molar. A total of 75 patients aged 18-40 years with elevated dental anxiety were randomly assigned in a 1:1:1 ratio to a nature-based virtual reality group, an art-gallery virtual reality group, or a control group receiving conventional care without virtual reality.
Participants in the two virtual reality groups wore the same headset and headphones and viewed standardized 360-degree content from the beginning of surgery until completion of the procedure. Anxiety was assessed using the Modified Dental Anxiety Scale, the State-Trait Anxiety Inventory-State subscale, and an 11-point numerical anxiety rating scale. Systolic and diastolic blood pressure, heart rate, and peripheral oxygen saturation were also recorded. Measurements were obtained before local anesthesia, after local anesthesia but before surgery and virtual reality exposure, and immediately after wound closure, as applicable. The study compared changes in anxiety and physiological measures among the three groups and examined whether nature-based and art-gallery virtual reality content produced different responses.
調査の概要
研究の種類
介入
入学 (実際)
75
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Rize Province
-
Rize、Rize Province、トルコ（Türkiye）、53020
- Recep Tayyip Erdogan University Faculty of Dentistry
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age between 18 and 40 years
- American Society of Anesthesiologists (ASA) physical status I
- Presence of an impacted mandibular third molar for which surgical removal was indicated
- Pell and Gregory Class II, position B impaction
- Vertical or mesioangular impaction according to Winter's classification
- Preoperative Modified Dental Anxiety Scale (MDAS) score of 11 or higher
- Ability to understand the study procedures and complete the questionnaires
- Provision of written informed consent
Exclusion Criteria:
- A systemic or psychiatric condition considered likely to influence anxiety responses
- Regular use of medication that could alter anxiety or autonomic responses
- Use of antipsychotic or anxiolytic medication
- Smoking 10 or more cigarettes per day
- Previous surgical removal of an impacted tooth
- Acute infection in the operative region
- Pregnancy
- Severe visual or hearing impairment that could prevent adequate virtual reality exposure
- Inability to tolerate or correctly use the virtual reality headset
- Surgical duration exceeding 30 minutes
- Withdrawal of consent at any stage of the study
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Nature-Based Virtual Reality
Participants viewed standardized investigator-developed nature-based 360-degree immersive content using a virtual reality headset and headphones from the beginning of surgery until completion of the procedure.
Exposure duration was determined by surgical duration and did not exceed 30 minutes.
|
Participants viewed standardized investigator-developed nature-based 360-degree immersive content using a virtual reality headset and headphones.
The intervention began at the start of surgery and continued until completion of the procedure.
Exposure duration was determined by surgical duration and did not exceed 30 minutes.
|
|
実験的：Art-Gallery Virtual Reality
Participants viewed standardized investigator-developed art-gallery 360-degree immersive content using the same virtual reality headset, headphones, audiovisual settings, and exposure period as the nature-based virtual reality group.
Exposure continued from the beginning of surgery until completion of the procedure and did not exceed 30 minutes.
|
Participants viewed standardized investigator-developed art-gallery 360-degree immersive content using the same virtual reality headset, headphones, audiovisual settings, and exposure period as the nature-based virtual reality group.
The intervention began at the start of surgery and continued until completion of the procedure.
Exposure duration was determined by surgical duration and did not exceed 30 minutes.
|
|
介入なし：Conventional Care Without Virtual Reality
Participants underwent the same standardized surgical procedure and received conventional clinical care without a virtual reality headset or an alternative audiovisual intervention.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Modified Dental Anxiety Scale Score
時間枠：From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
|
Dental anxiety was assessed using the five-item Modified Dental Anxiety Scale (MDAS).
Each item is scored from 1 to 5, producing a total score ranging from 5 to 25, with higher scores indicating greater dental anxiety.
The outcome was the change in total MDAS score from T0 to T2, calculated as the T2 score minus the T0 score.
|
From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
|
|
Change in State-Trait Anxiety Inventory-State Subscale Score
時間枠：From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
|
State anxiety was assessed using the 20-item State-Trait Anxiety Inventory-State subscale (STAI-S).
Each item is scored from 1 to 4, producing a total score ranging from 20 to 80, with higher scores indicating greater state anxiety.
The outcome was the change in total STAI-S score from T0 to T2, calculated as the T2 score minus the T0 score.
|
From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Anxiety Visual Analog Scale Score
時間枠：At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
Momentary anxiety was assessed using the study-designated Anxiety Visual Analog Scale (VAS-A), administered as an 11-point whole-number response scale ranging from 0 to 10.
A score of 0 indicated no anxiety, whereas a score of 10 indicated the highest perceived anxiety.
Changes in VAS-A scores across T0, T1, and T2 were compared among the study groups.
|
At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
|
Change in Systolic Blood Pressure
時間枠：At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
Systolic blood pressure was measured in millimeters of mercury (mmHg) using the same automated monitoring device during a standardized five-minute assessment period at each time point.
Changes in systolic blood pressure across T0, T1, and T2 were compared among the study groups.
|
At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
|
Change in Diastolic Blood Pressure
時間枠：At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
Diastolic blood pressure was measured in millimeters of mercury (mmHg) using the same automated monitoring device during a standardized five-minute assessment period at each time point.
Changes in diastolic blood pressure across T0, T1, and T2 were compared among the study groups.
|
At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
|
Change in Heart Rate
時間枠：At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
Heart rate was measured in beats per minute (bpm) using the same automated monitoring device during a standardized five-minute assessment period at each time point.
Changes in heart rate across T0, T1, and T2 were compared among the study groups.
|
At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
|
Change in Peripheral Oxygen Saturation
時間枠：At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
Peripheral oxygen saturation was measured as a percentage (SpO2) using the same monitoring device during a standardized five-minute assessment period at each time point.
Changes in peripheral oxygen saturation across T0, T1, and T2 were compared among the study groups.
|
At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年10月1日
一次修了 (実際)
2026年6月30日
研究の完了 (実際)
2026年6月30日
試験登録日
最初に提出
2026年9月8日
QC基準を満たした最初の提出物
2026年9月8日
最初の投稿 (実際)
2026年9月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月16日
QC基準を満たした最後の更新が送信されました
2026年9月13日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2025/353
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
De-identified individual participant data underlying the results reported in the published article will be made available by the corresponding author upon reasonable request.
IPD 共有時間枠
Data will be available beginning after publication of the main study results and will remain available for five years following publication.
IPD 共有アクセス基準
Requests should be submitted to the corresponding author at ismailburak.halat@erdogan.edu.tr and should include a scientifically sound research proposal.
Requests will be evaluated for compatibility with participant consent, ethics approval, and applicable data-protection requirements.
Data will be shared with qualified researchers for approved scientific purposes, and a data-use agreement may be required.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。