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Immersive Virtual Reality to Reduce Procedural Pain During IV Insertion in Children in the Emergency Department

7 октября 2019 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

58

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Канада
    • Ontario
      • Toronto, Ontario, Канада, M5G 1X8
        • Hospital for Sick Children

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 8 лет до 18 лет (Ребенок, Взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion criteria will be:

  1. aged 8-17 years
  2. able to speak and understand English
  3. parent/guardian present
  4. 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)
  5. requires IV insertion

Exclusion criteria will be:

  1. visual, auditory or cognitive impairments precluding interaction with the VR intervention or reporting pain and fear
  2. psychiatric conditions that could be exacerbated by the VR environment (i.e. hallucinations)
  3. skin, face or ear infections or injuries, which could contaminate the intervention equipment
  4. medically unstable (CTAS 1; patient requires immediate IV insertion)

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Устройство: Virtual Reality Program
VR with head mounted display (HMD) and headphones.
Активный компаратор: 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).
Устройство: iPad Tablet
iPad with headphones

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Pain Intensity
Временное ограничение: Baseline, 30 minutes after baseline
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.
Baseline, 30 minutes after baseline
Change in Child Distress
Временное ограничение: Baseline, 30 minutes after baseline
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
Baseline, 30 minutes after baseline
Change in Child Fear
Временное ограничение: Baseline, 30 minutes after baseline
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.
Baseline, 30 minutes after baseline
Child Pain Catastrophizing
Временное ограничение: Baseline
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.
Baseline
Parent Pain Catastrophizing
Временное ограничение: Baseline
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.
Baseline
Parent Distress
Временное ограничение: 30 minutes after baseline measures are completed
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.
30 minutes after baseline measures are completed
Child Presence Measure
Временное ограничение: 30 minutes after baseline measures are completed
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").
30 minutes after baseline measures are completed

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Recruitment log
Временное ограничение: through study completion, an average of 1 year
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.
through study completion, an average of 1 year
Acceptability
Временное ограничение: 30 minutes after baseline measures are completed
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.
30 minutes after baseline measures are completed
Outcome measure feasibility
Временное ограничение: through study completion, an average of 1 year
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.
through study completion, an average of 1 year
Technical Difficulties Log
Временное ограничение: through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

The Hospital for Sick Children

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 февраля 2018 г.

Первичное завершение (Действительный)

30 сентября 2019 г.

Завершение исследования (Действительный)

30 сентября 2019 г.

Даты регистрации исследования

Первый отправленный

19 января 2018 г.

Впервые представлено, что соответствует критериям контроля качества

9 февраля 2018 г.

Первый опубликованный (Действительный)

19 февраля 2018 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

9 октября 2019 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

7 октября 2019 г.

Последняя проверка

1 октября 2019 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 1000058799

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Virtual Reality Program

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