Effectiveness of Virtual Reality in Reducing Anxiety and Pain During the First Postoperative Orthopedic Dressing Change in Pediatric Patients (VR OrthoPed)
Effectiveness of Virtual Reality in Reducing Anxiety and Pain During the First Postoperative Orthopedic Dressing Change in Pediatric Patients: A Randomized Controlled Trial
The goal of this randomized clinical trial is to learn whether immersive virtual reality can reduce anxiety and pain in children and adolescents undergoing postoperative orthopedic dressing changes. The main questions it aims to answer are:
Does immersive virtual reality reduce anxiety during postoperative dressing changes compared with standard care?
Does immersive virtual reality reduce pain and physiological signs of distress, such as changes in heart rate and respiratory rate?
Researchers will compare participants who use an immersive virtual reality headset during the dressing change with participants who receive standard care without virtual reality.
Participants will:
Be randomly assigned to the virtual reality group or the standard care group
Undergo a postoperative orthopedic dressing change with or without immersive virtual reality
Report their anxiety and pain before and after the procedure
Have their heart rate and respiratory rate measured before, during, and after the dressing change
調査の概要
状態
詳細な説明
Postoperative orthopedic dressing changes can cause anxiety, pain, and physiological distress in pediatric patients. Immersive virtual reality may provide a non-pharmacological form of distraction by directing the participant's attention away from the clinical procedure and toward an engaging virtual environment.
This randomized clinical trial was conducted in a pediatric orthopedic unit to evaluate the use of immersive virtual reality during postoperative dressing changes. After enrollment and baseline assessment, participants were randomly assigned to receive either immersive virtual reality in addition to the usual dressing procedure or standard care alone.
Participants assigned to the virtual reality group wore a head-mounted display and viewed an immersive virtual environment during the dressing change. Participants assigned to the standard care group underwent the same clinical procedure according to usual practice without virtual reality. The dressing change was performed by the clinical team in accordance with routine postoperative care.
Anxiety, pain, heart rate, respiratory rate and peripheral oxygen saturation were assessed at predefined time points before, during, and after the procedure, as applicable. These measurements were used to examine whether immersive virtual reality was associated with reduced psychological and physiological distress during the dressing change.
The study was designed to provide evidence on the potential usefulness of immersive virtual reality as a non-drug supportive intervention during postoperative procedures in pediatric orthopedic care.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
Liguria
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Genoa、Liguria、イタリア、16132
- Dipartimento di scienze della salute, DISSAL - UNIGE
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria
- Patients aged 6-18 years.
- Undergoing corrective orthopedic surgery for congenital or acquired limb deformities, with or without external fixation devices, or spinal arthrodesis for scoliosis or spondylolisthesis.
- Undergoing the first postoperative wound dressing procedure.
- Written informed consent obtained from a parent or legal guardian.
- Assent obtained from the participant, when appropriate. Exclusion Criteria
- Neurological disorders.
- History of epilepsy.
- Prematurity.
- Sensory impairments preventing the use of the virtual reality headset.
- Cognitive impairments preventing the use of the virtual reality headset.
- Motor limitations preventing the use of the virtual reality headset.
研究計画
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：Immersive Virtual Reality Plus Standard Care
Participants received the first postoperative orthopedic dressing procedure according to routine clinical practice while using an immersive virtual reality headset.
The headset displayed an immersive virtual environment throughout the dressing procedure as a non-pharmacological distraction intervention.
Standard clinical monitoring and nursing care were provided.
|
Participants used an immersive virtual reality headset during the first postoperative orthopedic dressing procedure.
The headset presented an immersive virtual environment intended to divert attention from the clinical procedure and reduce anxiety, pain, and physiological stress.
The virtual reality intervention was provided in addition to the routine postoperative dressing care delivered by the clinical team.
The headset was worn during the dressing procedure and removed after its completion.
|
|
アクティブコンパレータ：Standard Care Alone
Participants received the first postoperative orthopedic dressing procedure according to routine clinical practice without the use of immersive virtual reality.
Standard clinical monitoring and nursing care were provided.
|
Participants underwent the first postoperative orthopedic dressing procedure according to routine clinical practice without the use of immersive virtual reality.
Standard nursing care and clinical monitoring were provided throughout the procedure.
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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 |
|---|---|---|
|
Change in Anxiety Assessed Using the Visual Analogue Scale for Anxiety
時間枠：Immediately before and immediately after the first postoperative orthopedic dressing procedure
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Anxiety was assessed using the Visual Analogue Scale for Anxiety (VAS-A), a 100 mm horizontal scale ranging from 0, indicating no anxiety, to 100, indicating maximum anxiety.
Higher scores indicate greater anxiety.
Change in anxiety was calculated as the score immediately after the procedure minus the score immediately before the procedure.
A negative change score indicates a reduction in anxiety.
|
Immediately before and immediately after the first postoperative orthopedic dressing procedure
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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 |
|---|---|---|
|
Change in Pain Intensity Assessed Using the Faces Pain Scale
時間枠：Immediately before and immediately after the first postoperative orthopedic dressing procedure
|
Pain intensity in participants aged 6 to 10 years was assessed immediately before and immediately after the first postoperative orthopedic dressing procedure using the Faces Pain Scale.
Higher scores indicate greater pain intensity.
Change in pain was calculated as the post-procedure score minus the pre-procedure score.
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Immediately before and immediately after the first postoperative orthopedic dressing procedure
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Change in Pain Intensity Assessed Using the Numeric Rating Scale
時間枠：Immediately before and immediately after the first postoperative orthopedic dressing procedure.
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Pain intensity in participants older than 10 years was assessed immediately before and immediately after the first postoperative orthopedic dressing procedure using the Numeric Rating Scale (0-10).
Higher scores indicate greater pain intensity.
Change in pain was calculated as the post-procedure score minus the pre-procedure score.
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Immediately before and immediately after the first postoperative orthopedic dressing procedure.
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- VR OrthoPed
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?
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
米国FDA規制機器製品の研究
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