Improving Sleep in the Pediatric Intensive Care Unit
Improving Sleep and Outcomes in Critically Ill Children
Sleep is disrupted in the PICU. This disruption has been reported in studies that have used: (a) observation of sleep-wake cycles (b) self-reports by children themselves , and (c) objective measures (e.g., electroencephalograph( EEG). Noise and light levels have been correlated with profound sleep disruption in the PICU . Sleep disruption is known to have a profound impact on the overall health of a child, both from a physiological and a psychological standpoint . In addition, sleep disruption has been shown to change cortisol levels, cause impaired immune responses and impair cognitive function in both children and adults . Disruption in sleep also is known to impair healing through these many complex connections with other homeostatic processes in the human body. What is the effect of wearing earplugs in critically ill children admitted to the PICU on:
- Sleep states
- Physiological stability (e.g. melatonin, cortisol and immune status)
- Sleep habits after discharge from the PICU (on the general pediatric unit, 2 weeks and 2 months after discharge), and
- Child behavior at 2 weeks and 2 months after discharge from the PICU by parent report on the Child Behavior Checklist (CBCL).
調査の概要
詳細な説明
While often life saving, the need for admission to the pediatric intensive care unit (PICU) places children in a profoundly artificial environment that has the potential to alter the biological processes that defend homeostasis. All living organisms have biological rhythms that serve as their basic organizing feature. These rhythms vary widely, ranging from seconds (e.g., heartbeat) to weeks (menstrual cycle). Biological rhythms that have a 24-hour cycle are termed circadian rhythms. Of the many circadian rhythms, the sleep-wake cycle is the most evident [2]. Other biological processes that have a circadian rhythm include growth hormone, melatonin, and cortisol secretion .
Sleep is disrupted in the PICU. This disruption has been reported in studies that have used: (a) observation of sleep-wake cycles [6, 7]; (b) self-reports by children themselves, and (c) objective measures (e.g., electroencephalograph( EEG). Noise and light levels have been correlated with profound sleep disruption in the PICU . Sleep disruption is known to have a profound impact on the overall health of a child, both from a physiological and a psychological standpoint . In addition, sleep disruption has been shown to change cortisol levels, cause impaired immune responses and impair cognitive function in both children and adults . Disruption in sleep also is known to impair healing through these many complex connections with other homeostatic processes in the human body.
There is a dearth of research on improving sleep and reversing the negative effects of sleep disruption on homeostasis in critically ill children
RQ1: What is the effect of wearing earplugs in critically ill children admitted to the PICU on:
- Sleep states
- Physiological stability (e.g. melatonin, cortisol and immune status)
- Sleep habits after discharge from the PICU (on the general pediatric unit, 2 weeks and 2 months after discharge), and
- Child behavior at 2 weeks and 2 months after discharge from the PICU by parent report on the Child Behavior Checklist (CBCL).
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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New York
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Rochester、New York、アメリカ、14642
- University of Rochester
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Parents or primary caregivers ages 18 years or older, who can read and speak English and their critically ill children who meet the following criteria will be eligible for participation (a) ages 1-15 years, (b) anticipated survival, (c) no severe handicapping (neurological) conditions, (d) not a prior transplant patient, (e) no active oncology or metabolic process (other than diabetes), (f) not diagnosed with a traumatic brain injury and (a) between 1 and 15 years of age, (b) expected length of stay >2days, (c) expected to live, and (d) parents that can read and write English
Exclusion Criteria:
- diagnosis of cancer, a previous transplant patient, diagnosis of a metabolic disorder (except for diabetes), neurological conditions that would affect sleep wake cycles, a traumatic brain injury patient, evidence of abuse. These conditions are known to affect sleep patterns and/or immune system and (a) not meeting inclusion criteria, (b) anticipated death of the child, (c) parents/primary caregiver make a personal choice to withdraw themselves and their child from the study, (d) the child has evidence of abuse.
研究計画
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:防止
- 割り当て:ランダム化
- 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)
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 |
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To pilot test the changes in sleep patterns with the use of earplugs in the PICU
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二次結果の測定
結果測定 |
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To see if there are neurobehavioral differences in children who use the earplugs in the PICU vs, those who do not
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Heidi V. Connolly, MD、University of Rochester
- 主任研究者:Margaret-Ann Carno, PhD, RN、University of Rochester
研究記録日
主要日程の研究
研究開始
研究の完了
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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。