Virtual Reality for Anxiolysis During Laceration Repair in the Pediatric Emergency Room
2019年12月1日 更新者：Daniel Marc Fein、Montefiore Medical Center
A Feasibility Study for the Use of Virtual Reality to Reduce Procedural Anxiety for Children Undergoing Laceration Repair in the Pediatric Emergency Room
The investigators propose a pilot study to examine the feasibility of utilizing immersive virtual reality to reduce procedural anxiety in children undergoing non-facial laceration repair in the Pediatric Emergency Department.
The investigators hypothesize that virtual reality will be well-received by patients and their caregivers, and that the anxiety provoked by laceration repair will be mitigated by the immersive virtual reality experience.
調査の概要
研究の種類
介入
入学 (実際)
40
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
-
-
New York
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Bronx、New York、アメリカ、10467
- Children's Hospital at Montefiore
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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
5年～13年 (子)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- children 5-13 years of age
- present to ED during the study period with non-facial lacerations
- patient to undergo wound closure with sutures
Exclusion Criteria:
- Patients with lacerations on the head/face
- Patients with lacerations sustained in conjunction with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma
- Patients who sustained a laceration in conjunction with an open fracture
- Patients with open skin, lice, scabies, or other infectious skin conditions on the head/face
- Patients with a history of or current symptoms of vertigo
- Patients who are blind
- Patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver
- Patients on whom the VR headset does not fit appropriately
- Non-English speaking patients will be excluded from this study (we do not have funds available to translate the study documents into other languages)
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：処理
- 割り当て：なし
- 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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実験的：Virtualy Reality App
Virtual reality app produced by KindVR played via a stereoscopic head mounted display (Samsung GearVR) and headphones that the patient will wear over their eyes and ears.
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Virtual reality app produced by KindVR played via a stereoscopic head mounted display (Samsung GearVR) and headphones that the patient will wear over their eyes and ears.
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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 |
|---|---|---|
|
The percentage of children whose anxiety score did NOT increase by ≥ 20mm on a visual analog anxiety scale
時間枠：from the time of enrollment to the placement of the first stitch, which is typically ranges from 15 to 90 minutes
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Anxiety score will be measured on a Visual Analog Scale.
This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).
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from the time of enrollment to the placement of the first stitch, which is typically ranges from 15 to 90 minutes
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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 anxiety score
時間枠：from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes
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Anxiety score will be measured on a Visual Analog Scale.
This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).
|
from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes
|
|
Change in anxiety score
時間枠：from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes
|
Anxiety score will be measured on a Visual Analog Scale.
This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).
|
from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes
|
|
Change in anxiety score
時間枠：from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
|
Anxiety score will be measured on a Visual Analog Scale.
This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).
|
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
|
|
Patient satisfaction with the use of VR during the procedure as assessed by a patient questionnaire
時間枠：Patients will fill out the questionnaire at the time their sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
|
To assess the receptiveness of patients to this technology as well as the efficacy of the VR experience, participants will be asked to complete a brief questionnaire at the end of the procedure assessing their experience while using VR during the laceration repair. These surveys address the patient's comfort and satisfaction with the technology. We have created separate patient surveys for children ages 5-7 and children ages 8-13 - these surveys have the same questions, but the answer choices are simplified from Likert Rating Scales (scale of 1 - 5) for the older children to a simple "Yes, No, I don't know" choice for the younger children. There is also a free text response question for which patients can provide additional comments or suggestions regarding their use of VR during laceration repair. |
Patients will fill out the questionnaire at the time their sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
|
|
Parent/guardian satisfaction with the use of VR during the procedure as assessed by a parent/guardian questionnaire
時間枠：Parent/guardian will fill out the questionnaire at the time their child's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
|
To assess the receptiveness of patients to this technology as well as the efficacy of the VR experience, parents/guardians will be asked to complete a brief survey at the end of the procedure assessing their comfort and satisfaction with their child's use of VR during the laceration repair.
The survey contains both rating questions with Likert Rating Scales (scale of 1 - 5), yes/no questions, and questions with free text responses.
|
Parent/guardian will fill out the questionnaire at the time their child's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
|
|
Provider satisfaction with the use of VR during the procedure as measured by a provider questionnaire
時間枠：Providers will fill out the questionnaire at the time their patient's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
|
The ED provider who performed the laceration repair will complete a survey at the end of the procedure assessing their satisfaction with using VR during laceration repair.
The survey contains yes/no questions, multiple choice questions, and questions with free text responses.
|
Providers will fill out the questionnaire at the time their patient's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
|
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Need for adjunctive anxiolysis methods, sedation, or restraints during the procedure as reported on a provider questionnaire
時間枠：from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
|
The ED provider who performed the laceration repair will complete a questionnaire at the end of the procedure which will detail which, if any, adjunctive measures were needed during the procedure.
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from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
|
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Headache due to VR use as reported on a qualitative simulator sickness questionnaire
時間枠：from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
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The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain.
The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
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from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
|
|
Eye pain due to VR use as reported on a qualitative simulator sickness questionnaire
時間枠：from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
|
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain.
The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
|
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
|
|
Nausea due to VR use as reported on a qualitative simulator sickness questionnaire
時間枠：from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
|
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain.
The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
|
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
|
|
Dizziness due to VR use as reported on a qualitative simulator sickness questionnaire
時間枠：from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
|
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain.
The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
|
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
|
|
Barriers to the use of VR identified during this study as reported on a provider questionnaire
時間枠：from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
|
The ED provider who performed the laceration repair will complete a questionnaire at the end of the procedure which will detail which, if any, barriers to the use of VR that they encountered during the procedure
|
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
|
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)
2018年4月15日
一次修了 (実際)
2019年11月22日
研究の完了 (実際)
2019年11月22日
試験登録日
最初に提出
2018年3月10日
QC基準を満たした最初の提出物
2018年3月16日
最初の投稿 (実際)
2018年3月23日
学習記録の更新
投稿された最後の更新 (実際)
2019年12月3日
QC基準を満たした最後の更新が送信されました
2019年12月1日
最終確認日
2019年12月1日
詳しくは
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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