Virtual Reality Distraction During Pediatric Intravenous Line Placement
Virtual Reality Distraction During Pediatric Intravenous Line Placement: A Prospective Randomized Comparison Study
調査の概要
詳細な説明
Children often describe procedures involving needles as the most stressful portion of the hospital experience. 1,2 Many studies involving the perception of pain have highlighted the importance of attention for the perception of pain, and, conversely, the benefit of distraction for decreasing pain perception. 3,4 Virtual reality technologies (VR) have been shown to mitigate the experience of pain and anxiety in patients undergoing procedures in a number of different ways. 5,6 While small studies have demonstrated the use of VR to be effective in diminishing pain during intravenous (IV) placement for outpatient imaging in pediatric patients aged 8-12, there have not been large-scale studies assessing the use of VR during IV placement in the Pediatric Emergency Department. 7 Studies examining the use of VR during venipuncture and IV placement also frequently focus on self-reported or parent-reported pain, rather than objectively quantifying number of IV sticks and time to successful IV placement.8 Additionally, the pediatric age ranges which benefit from VR have not been well-established, with some studies citing benefits only in patients over 10 years of age, and others showing improvements in all age groups.7,9,10
This study aims to prospectively investigate the use of virtual reality headsets on the placement of IVs in a pediatric emergency department, by comparing the first stick success rate, total number of attempts, and the time to successful IV placement between patients who use virtual reality headset technology during the placement and those who receive the standard of care IV placement when child life ( individuals with special training in aiding and augmenting pediatric coping skills) is not available. The investigators will also compare the patient and parent perception of pain and anxiety associated with the IV placement in both study groups. Finally, by detailing which medications have been given prior to use of the VR for IV placement the investigators may evaluate for possible synergistic effects of VR with prior medication administration.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Texas
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Austin、Texas、アメリカ、78723
- 募集
- Dell Children's Medical Center of Central Texas
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コンタクト:
- Matthew Wilkinson, MD
- 電話番号:512-547-8362
- メール:mhwilkinson@ascension.org
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patient aged 4-17 years
- Requiring IV placement
- Child Life unavailable
Exclusion Criteria:
- Previous enrollment in the study
- Physically/ developmentally unable to tolerate headset
- Skin/eye pathology
- Critically ill patient
- Language other than English or Spanish
- Student Nurse placing IV
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:他の
- 割り当て:ランダム化
- 介入モデル:単一グループの割り当て
- 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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介入なし:IV placement no Virtual reality
Patient will have IV placed in traditional manner, with no virtual reality headset
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実験的:IV placement with Virtual Reality
Patient will have IV placed with Virtual Reality headset distraction
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Virtual Reality Headset applied to the patient during placement of IV.
Control is patient group without headset applied.
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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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Successful IV placement with first attempt
時間枠:6 months
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success in first attempt in VR group vs non VR group
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6 months
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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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number of attempts before successfully establishing IV
時間枠:6 months
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number of attempts before successful IV placement in VR group vs non VR group
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6 months
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time to establishing successful IV
時間枠:6 months
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time to establishing successful IV in VR group vs non VR group
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6 months
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Pre vs Post FACES revised pain scale parents
時間枠:6 months
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Pre vs Post FACES pain scale in VR group vs non VR group
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6 months
|
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Pre vs Post FACES revised pain Scale patients
時間枠:6 months
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Pre vs Post FACES pain scale in VR group vs non VR group
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6 months
|
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Pre vs Post Likert-Type Anxiety Scale - parents
時間枠:6 months
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Pre vs Post Likert-Type Anxiety Scale of parents in VR group vs non VR group
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6 months
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Pre vs Post Likert-Type Anxiety Scale- patients
時間枠:6 months
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Pre vs Post Likert-Type Anxiety Scale of patients in VR group vs non VR group
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6 months
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age range of patients that tolerate VR
時間枠:6 months
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Which of evaluated age range of 4-17 years tolerate VR placement
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6 months
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
その他の研究ID番号
- ASalinas
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
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。
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