Virtual Reality for Anxiolysis During Laceration Repair in the Pediatric Emergency Room
2019년 12월 1일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New York
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Bronx, New York, 미국, 10467
- Children's Hospital at Montefiore
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
5년 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The percentage of children whose anxiety score did NOT increase by ≥ 20mm on a visual analog anxiety scale
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in anxiety score
기간: 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).
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from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes
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Change in anxiety score
기간: from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 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 enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes
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Change in anxiety score
기간: from enrollment to procedure completion, which typically ranges from 20 to 180 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 enrollment to procedure completion, which typically ranges from 20 to 180 minutes
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|
Patient satisfaction with the use of VR during the procedure as assessed by a patient questionnaire
기간: 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
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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
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Parent/guardian satisfaction with the use of VR during the procedure as assessed by a parent/guardian questionnaire
기간: 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.
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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
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Provider satisfaction with the use of VR during the procedure as measured by a provider questionnaire
기간: 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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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.
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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
기간: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
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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
기간: 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
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Eye pain due to VR use as reported on a qualitative simulator sickness questionnaire
기간: 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
|
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Nausea due to VR use as reported on a qualitative simulator sickness questionnaire
기간: 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
기간: 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
기간: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
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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
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from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 4월 15일
기본 완료 (실제)
2019년 11월 22일
연구 완료 (실제)
2019년 11월 22일
연구 등록 날짜
최초 제출
2018년 3월 10일
QC 기준을 충족하는 최초 제출
2018년 3월 16일
처음 게시됨 (실제)
2018년 3월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 12월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 12월 1일
마지막으로 확인됨
2019년 12월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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