Immersive Virtual Reality to Reduce Procedural Pain During IV Insertion in Children in the Emergency Department
2019年10月7日 更新者：Jennifer Stinson、The Hospital for Sick Children
Immersive Virtual Reality to Reduce Procedural Pain During IV Insertion in Children in the Emergency Department: A Feasibility Pilot Study
Venipuncture and intravenous (IV) access continue to be the most common causes of pain and distress among children in the pediatric emergency department.
Virtual reality has been successful for reducing pain and fear in many clinical scenarios, including port access in oncology patients, anxiety disorders, phobias, burn and wound care and others.
There is only one previous study examining virtual reality distraction to reduce procedural pain during IV insertion in pediatric patients and no previous studies examining this in the emergency department setting.
In this study, the investigators will compare immersive virtual reality (an interactive underwater environment) to the current standard (tablet device/iPad playing a movie) for distraction to reduce procedural pain during IV insertion.
The investigators hypothesize that the immersive quality of the virtual reality will reduce patient's pain scores, fear scores and tachycardia during and after the procedure, and have minimal effect on departmental flow and nursing satisfaction.
If this feasibility pilot study yields positive results, the investigators plan to expand to a larger randomized control trial.
調査の概要
状態
完了
詳細な説明
This study is a pilot randomized control trial that aims to (a) to determine the differences in self-reported and proxy-reported pain and fear during IV insertion between the interactive VR intervention and control group, and (b) to assess the feasibility (safety, acceptability) of the VR intervention to children/families and the healthcare team in the pediatric emergency department.
The study will consist of two study arms, where both study arms will be screened and recruited using the same procedure.
Participants will be randomized into either (1) Control group: child life specialist plays an age-appropriate video on a tablet device, or (2) Intervention (VR Distraction): child life specialist facilitates immersive VR experience.
Both the intervention and control groups will receive standard medical care (e.g., topical anesthetics).
A convenience sample of 80 children and adolescents with cancer (40 participants per treatment arm; 20 boys and 20 girls per treatment arm) will be recruited.
In addition to usual care, children in the experimental condition will wear the VR headset plus headphones.
In the control condition, children will watch a video (i.e., an age-appropriate video selected by an emergency department affiliated child life specialist) on an iPad, while wearing the same headphones as in the experimental condition.
Implementation outcomes include accrual and retention rates, acceptability and technical difficulties.
Effectiveness outcomes include child pain, distress, and fear, as well as parent distress.
研究の種類
介入
入学 (実際)
58
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
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Ontario
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Toronto、Ontario、カナダ、M5G 1X8
- Hospital for Sick Children
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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
8年～18年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion criteria will be:
- aged 8-17 years
- able to speak and understand English
- parent/guardian present
- medically stable (CTAS 2, 3, 4 or 5; IV insertion +/-20 minutes will not impact the safety of the patient according to treating medical team)
- requires IV insertion
Exclusion criteria will be:
- visual, auditory or cognitive impairments precluding interaction with the VR intervention or reporting pain and fear
- psychiatric conditions that could be exacerbated by the VR environment (i.e. hallucinations)
- skin, face or ear infections or injuries, which could contaminate the intervention equipment
- medically unstable (CTAS 1; patient requires immediate IV insertion)
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：ランダム化
- 介入モデル：並列代入
- マスキング：独身
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：Intervention Group (VR)
The patient will be allowed to 'try-out' the VR system (including all auditory and visual features) for ~5 minutes prior to the start of the procedure.
In addition to usual care, consisting of child-life presence and topical analgesics if ordered by the treating medical team, children in the experimental condition will wear the VR HMD plus headphones and hold the VR controller.
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VR with head mounted display (HMD) and headphones.
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アクティブコンパレータ：Control Group (Standard Care - Video)
The patient will be allowed to watch an age-appropriate video on a tablet device.
The patient will be offered to wear the same headphones as in the experimental condition.
The patient will have the tablet and headphones for ~5 minutes prior to the start of the procedure.
In addition, the patient will receive standard care consisting of a child life specialist and topical analgesics (if ordered by the treating medical team).
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iPad with headphones
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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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Change in Pain Intensity
時間枠：Baseline, 30 minutes after baseline
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Using an 11 point Numerical Rating Scale (NRS) (0 being no distress at all and 10 being the most distress you can imagine this child or you having) children will self-report their pain and parents, nurses and the researcher will report children's pain BOTH prior to and following the procedure.
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Baseline, 30 minutes after baseline
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Change in Child Distress
時間枠：Baseline, 30 minutes after baseline
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Using an 11 point Numerical Rating Scale (NRS) (0 being no distress at all and 10 being the most distress you can imagine this child or you having) children will self-report their distress and parents, nurses and the researcher will report children's distress BOTH prior to and following the procedure
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Baseline, 30 minutes after baseline
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Change in Child Fear
時間枠：Baseline, 30 minutes after baseline
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Children will report fear BOTH prior to and following the procedure using the Child Fear Scale (CFS) which is a 5-face visual scale that measures fear intensity and is validated in children as young as 5 years.
It consists of a 1-question scale rating fear from 0 - 4, based on the faces provided.
A higher number represents higher fear intensity.
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Baseline, 30 minutes after baseline
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Child Pain Catastrophizing
時間枠：Baseline
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Children will report baseline tendencies to catastrophize about pain using the Pain Catastrophizing Scale - Child (PCS-C).
This is a self-report measure of children's tendency to catastrophize about pain validated in children 8-18 years of age.
6-items responded to on an 11-point scale from 0 ("not at all") to 10 ("a lot"), with a higher number representing higher pain catastrophizing.
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Baseline
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Parent Pain Catastrophizing
時間枠：Baseline
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Parents will report baseline tendencies to catastrophize about their child's pain using the Pain Catastrophizing Scale - Parent (PCS-P), which is a self-report measure of parents' tendency to catastrophize about their child's pain validated in parents of children 8-18 years of age.
6-items responded to on an 11-point scale from 0 ("not at all") to 10 ("a lot"), with a higher number representing higher parental pain catastrophizing of their child's pain.
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Baseline
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Parent Distress
時間枠：30 minutes after baseline measures are completed
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Parents will report on their own level of distress following the child's procedure using the Parent Distress Questionnaire.
This measure consists of 4-items responded to on an 11-point numeric rating scale from 0 ("not at all") to 10 ("extremely").
A higher number value represents higher distress levels.
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30 minutes after baseline measures are completed
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Child Presence Measure
時間枠：30 minutes after baseline measures are completed
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This child self-report measure assesses effectiveness of the immersive aspect of the VR toolkit/iPad using 12 questions, a choice of three answers ("no", "a little", and "a lot").
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30 minutes after baseline measures are completed
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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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Recruitment log
時間枠：through study completion, an average of 1 year
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Using an investigator-generated recruitment log, accrual rates will be measured by counting the number eligible children per recruitment day, participants enrolled, reasons for ineligibility, reasons for non-participation and reasons for study attrition.
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through study completion, an average of 1 year
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Acceptability
時間枠：30 minutes after baseline measures are completed
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Measured using the VR Distraction Satisfaction Questionnaire completed by children, parents and nurses and will collect data on acceptability, perceived utility of pain reducing procedures, and recommendations for changes related to the needle insertion experience.
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30 minutes after baseline measures are completed
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Outcome measure feasibility
時間枠：through study completion, an average of 1 year
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Will be measured as the percentage of completed outcome measures at baseline and study completion and will be recorded on the VR Distraction Activity Log.
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through study completion, an average of 1 year
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Technical Difficulties Log
時間枠：through study completion, an average of 1 year
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Using an investigator-generated technical difficulties log, researchers will record data related to technical difficulties associated with the VR intervention, observed difficulties in implementing the trial protocol in the clinic and time to complete IV needle insertion.
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through study completion, an average of 1 year
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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。
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2月1日
一次修了 (実際)
2019年9月30日
研究の完了 (実際)
2019年9月30日
試験登録日
最初に提出
2018年1月19日
QC基準を満たした最初の提出物
2018年2月9日
最初の投稿 (実際)
2018年2月19日
学習記録の更新
投稿された最後の更新 (実際)
2019年10月9日
QC基準を満たした最後の更新が送信されました
2019年10月7日
最終確認日
2019年10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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