Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction (VR-PED)
2026年7月3日 更新者：Sultan Qaboos University
"Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction: A Randomized Controlled Trial"
The goal of this clinical trial is to learn if virtual reality distraction can reduce dental anxiety and pain perception in children aged 6-10 years undergoing simple dental extraction. The main questions it aims to answer are:
Does virtual reality distraction lower dental anxiety compared to audio-visual distraction and conventional tell-show-do techniques?
Does virtual reality distraction reduce pain perception during dental extraction?
Researchers will compare virtual reality distraction, audio-visual distraction (2D cartoons with headset), and conventional tell-show-do with verbal distraction to see which method is most effective in improving child cooperation and reducing anxiety and pain.
Participants will:
Wear VR glasses to watch immersive 3D cartoons, or
Watch 2D cartoons with headset, or
Receive the conventional tell-show-do technique with verbal distraction.
Outcome measures will include child dental anxiety (CFSS-DS, VCARS), pain perception (Wong-Baker FACES), physiological parameters (pulse rate, SpO₂), and behavioral cooperation (Frankl scale).
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
168
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。
研究連絡先
- 名前：Dr.Zamzam AlQulhati Ali AlQulhati, BDS, MFD ( RSCI)
- 電話番号：+96895573313
- メール：zalqulhati@gmail.com
研究連絡先のバックアップ
- 名前：Azza AlShidhani Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd)
- 電話番号：+96895692669
- メール：azzak@squ.edu.om
研究場所
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Muscat、オマーン
- Sultan Qaboos University Hospital - Dental & Maxillofacial Department
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コンタクト：
- Azza Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd)
- 電話番号：+96895692669
- メール：Azzak@squ.edu.om
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コンタクト：
- Mohammed AlAzki, DSA
- 電話番号：+968-97674606
- メール：m.alazki@squ.edu.om
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副調査官：
- Mohammed AlAzki, Diploma in Dental Surgery Assi
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Muscat、オマーン
- The Medical City of Military and Security Service (Dental Center-AlKhoudh )
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コンタクト：
- Dr.Khalifa AlAzri, DclinDent (Ed), MPaeds (RCSEd)
- 電話番号：+968-98199877
- メール：Khalifaazri_omsb@outlook.com
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コンタクト：
- Majid AlFori, DSA
- 電話番号：00968-99668984
- メール：Superhero-9w8@gmail.com
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副調査官：
- Majid AlFori, Diploma in Dental Surgery Assi
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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
- 子
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Children aged 6 to 10 years
- Classified as ASA class 1 or 2 (healthy or with mild systemic disease)
- Those who demonstrated Frankl behavior rating 2 and 3 toward dental procedures
- Children with NO previous exposure to invasive dental procedure
- No prior experience using VR glasses
- Requiring extraction of mandibular deciduous molar under local anesthesia
Exclusion Criteria:
- ASA 3 and above
- Those who demonstrated Frankl behavior rating 1 and 4 toward dental procedures
- Special needs ( intellectual and developmental)
- Children on psychotropic medication
- Children wearing glasses
- Presence of intra-oral swelling
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 |
|---|---|
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実験的：Arm 1: Virtual Reality Distraction
Children wear VR glasses to watch immersive 3D cartoons during dental extraction.
Anxiety, pain, and cooperation are assessed using CFSS-DS, Wong-Baker FACES, VCARS, Frankl scale, and physiological parameters
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Children wear a virtual reality headset to watch immersive 3D cartoons during dental extraction.
This device provides distraction to reduce dental anxiety and pain perception.
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アクティブコンパレータ：Arm 2: Audio-Visual Distraction
Children watch 2D cartoons with headset during dental extraction.
Anxiety, pain, and cooperation are measured using the same scales and physiological parameters as the VR group.
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Children watch 2D cartoons with headset during dental extraction.
This behavioral technique provides distraction to reduce dental anxiety and pain perception.
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アクティブコンパレータ：Arm 3: Conventional Tell-Show-Do
Children receive the standard tell-show-do technique with verbal distraction during dental extraction.
Anxiety, pain, and cooperation are assessed using CFSS-DS, Wong-Baker FACES, VCARS, Frankl scale, and physiological parameters.
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Children receive the standard tell-show-do technique with verbal distraction during dental extraction.
This behavioral method is used to reduce dental anxiety and improve cooperation.
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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 |
|---|---|---|
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Child Dental Anxiety (Self-Report)
時間枠：Time Points: Baseline (before starting the procedure) and post-operative assessments ( after finishing the extraction)
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Change in child dental anxiety will be measured using the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS, Arabic version).
The CFSS-DS consists of 15 items, each scored from 1 (not afraid) to 5 (very afraid), yielding a total score range of 15 to 75.
Higher scores indicate greater dental anxiety (worse outcome).
The unit of measure is the CFSS-DS score.
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Time Points: Baseline (before starting the procedure) and post-operative assessments ( after finishing the extraction)
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Child Dental Anxiety (Observation-based Assessment)
時間枠：Time points: This scale will be measured at 4 time points during the procedure: T0(baseline)= 15 min before starting the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 mins after the extraction
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Change in child dental anxiety will also be assessed using Venham's Clinical Anxiety Rating Scale (VCARS).
This observational scale is scored from 0 (relaxed) to 5 (out of control), with a total score range of 0 to 5. Higher scores indicate greater observed anxiety (worse outcome).
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Time points: This scale will be measured at 4 time points during the procedure: T0(baseline)= 15 min before starting the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 mins after the extraction
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3a: Physiological Monitoring - Pulse Rate
時間枠：Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction
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Pulse rate will be monitored using a pulse oximeter. The unit of measure is beats per minute (bpm). In children, the normal resting pulse rate varies by age: Preschool children (3-5 years): ~80-120 bpm School-aged children (6-12 years): ~70-118 bpm Adolescents (13-18 years): ~60-100 bpm Higher values during the dental procedure indicate greater physiological arousal (worse outcome). |
Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction
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3b: Physiological Monitoring - Oxygen Saturation (SpO₂)
時間枠：Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction
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Oxygen saturation will be monitored using a pulse oximeter.
The unit of measure is percentage (%).
In healthy children, normal SpO₂ values are typically 95-100% at rest.
Lower values indicate poorer physiological status (i.e., worse outcomes).
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Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain Perception (Self-Report)
時間枠：at the end of the procedure
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Self-reported pain perception will be measured using the Wong-Baker FACES Pain Rating Scale (Arabic version).
This scale ranges from 0 (no pain) to 10 (worst pain), represented by facial expressions.
Higher scores indicate greater pain intensity (worse outcome), and lower scores indicate less pain intensity (better outcome)
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at the end of the procedure
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Child Behavior (Observation)
時間枠：Time Points: Baseline (before the dental extraction procedure) and follow-up assessment at 1 month post-procedure
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Child behavior will be assessed using the Frankl Behavior Rating Scale. This scale has four degrees:
The total score range is 1 to 4. Higher scores indicate more cooperative behavior (better outcome). |
Time Points: Baseline (before the dental extraction procedure) and follow-up assessment at 1 month post-procedure
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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。
スポンサー
捜査官
- スタディディレクター：Dr. Azza Khalid AlSHidhani, DclinDent (Ed), MPaeds (RCSEd)、Pediatric dental clinic , Dental and maxillofacial department (SQUH), University Medical City,
- スタディディレクター：Dr. Khalifa Mohammed AlAzri, DclinDent (Ed), MPaeds (RCSEd)、Pediatric dental clinic, Dental Center (Alkhoudh), The Medical City of Military and Security Services
- 主任研究者：Dr. Zamzam Ali Alqulhati, BDS, MFD(RCSI)、Oman Medical Specialty Boaered
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Barros Padilha DX, Veiga NJ, Mello-Moura ACV, Nunes Correia P. Virtual reality and behaviour management in paediatric dentistry: a systematic review. BMC Oral Health. 2023 Dec 12;23(1):995. doi: 10.1186/s12903-023-03595-7.
- Kasimoglu Y, Alpaycetin E, Ince G, Tuna Ince EB. Reduction of Dental Anxiety in Children Using Virtual Reality: A Randomised Controlled Trial. Eur J Paediatr Dent. 2025 Sep 1;26(3):185-191. doi: 10.23804/ejpd.2024.2109. Epub 2024 Oct 1.
- Gomez-Polo C, Vilches AA, Ribas D, Castano-Seiquer A, Montero J. Behaviour and Anxiety Management of Paediatric Dental Patients through Virtual Reality: A Randomised Clinical Trial. J Clin Med. 2021 Jul 7;10(14):3019. doi: 10.3390/jcm10143019.
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 (推定)
2026年9月1日
一次修了 (推定)
2027年8月31日
研究の完了 (推定)
2027年10月1日
試験登録日
最初に提出
2026年6月24日
QC基準を満たした最初の提出物
2026年7月3日
最初の投稿 (実際)
2026年7月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月9日
QC基準を満たした最後の更新が送信されました
2026年7月3日
最終確認日
2026年7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
- PED-VR-2026-A
- OMSBoard-2026 (その他の助成金/資金番号：Oman Medical Specialty Board)
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?
いいえ
IPD プランの説明
Individual participant data (IPD) will not be shared due to ethical considerations in pediatric populations, privacy concerns, and institutional policy.
Only aggregated results will be published in peer-reviewed journals and presented at scientific meetings.
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。