Tablet-based Interactive Distraction Preoperative Anxiety in Children: A Randomized Controlled Trial (TABLET)
Tablet-based Interactive Distraction for the Management of Preoperative Anxiety in Children: A Randomized Controlled Trial
연구 개요
상세 설명
It is estimated that 50% of children may suffer preoperative anxiety. They have a higher risk of generating postanesthetic delirium and behavioral changes in the postoperative period up to 67% of cases.
For the management of preoperative anxiety there are pharmacological and non-pharmacological treatments. Within the first group there's the use of benzodiazepines of short half life like midazolam, however, the use of this medication is not exempt of risks such as paradox reactions, respiratory depression, among others. This is why the non pharmacological mesures have taken force and every day there is more evidence regarding its effectiveness.
There are no reports in Chile or latin america regarding the use of this tools, this is why the investigators designed this study to prove the effectiveness of audiovisual distraction measures in reducing preparatory anxiety compared to premeditation with midazolam.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Valparaiso, 칠레, 2341131
- 모병
- Hospital Carlos Van Buren
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연락하다:
- Nathalie Lopez, M.D.
- 전화번호: 2364000
- 이메일: nathalielopez.jq@gmail.com
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연락하다:
- Anamaria Correa, M.D.
- 이메일: correanamaria@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Children aged 2-10 years, under major surgery ambulatory program at Hospital Carlos Van Buren, with no contraindication for the use of midazolam.
Exclusion Criteria:
Patients with cognitive impairment or sensory deficit Patients with previous history of major surgery will also be excluded Patients with myastenia "Hard airway" History of paroxystic reaction to benzodiazepines Attentional deficit hyperactivity disorder Sleep aphnea Full stomach Adenotonsillar hypertrophy Respiratory acute infections
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: TIBD Tablet-based video distraction
Children will receive of tablet-based interctive games in preoperatory room
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Table-based Interactive Distraction using video-games will be used to prove efficacy in preventing preoperative anxiety.
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활성 비교기: Midazolam
Children will be premedicated with usual treatmente (midazolam)
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Administration of midazolam oral or rectal 30 minutes to one hour prior to transfer to the theater.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Short version of the modified Yale Preoperative Anxiety Scale(mYPAS-SF)
기간: 6 hours
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Difference between the measurement of the mYPAS-SF applied in the preoperative time and prior to induction. The scale has 18 items in 4 categories. Maximum score is 100 points. The higher the score, the greater the anxiety. |
6 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Cooperation with the induction
기간: 30 minuts
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Scale with 10 items, 1 point for each one. 0 points shows an induction with perfect cooperation. This scale will be applied at the moment of the induction by the anesthesiologist |
30 minuts
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Changes in postoperative behavior
기간: 10 days
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The Post Behavioral Behavior Change Questionnaire (PHBQ) will be applied at the postoperative surgical control (7-10 days after the intervention).
This survey will be applied by people trained by the hospital's pediatric psychiatry team The higher the score, the more behavioral changes in the postoperative period
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10 days
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Emergence delirium
기간: 1 hour
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In the post-anesthesia recovery unit, the Emergency Delirium Scale for Pediatric Anesthesia (PAED) will be applied every 15 minutes during the first 30 minutes of their stay in the unit.
Score goes from 0 to 20.
Scores greater than 10 is considered as delirium.
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1 hour
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Parents Satisfaction
기간: 10 minuts
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A gradual scale will be applied to the parents of the patient upon discharge from hospital.
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10 minuts
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공동 작업자 및 조사자
수사관
- 연구 책임자: Nathalie López, MD, Universidad de Valparaíso Chile
- 수석 연구원: Anamaria Correa, MD, Universidad de Valparaíso Chile
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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