Eye Covering and White Noise During Nasogastric Tube Insertion in Preterm Infants
The Effect of Eye Covering and White Noise During Nasogastric Tube Insertion on Comfort, Pain, Stress, and Physiological Parameters in Preterm Infants
This study aims to evaluate the effects of eye covering and white noise during nasogastric tube insertion on comfort, pain, stress, and physiological parameters in preterm infants. A total of 90 preterm infants will be randomly assigned to one of three groups: eye covering, white noise, or combined eye covering and white noise. Comfort, pain, stress, heart rate, respiratory rate, and oxygen saturation will be assessed before, during, and after nasogastric tube insertion.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Aysegu Simsek, PhD
- 電話番号：+905413155774
- メール：asimsek@marmara.edu.tr
研究場所
-
-
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Istanbul、トルコ（Türkiye）
- Bağcılar Training and Research Hospital
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主任研究者：
- Aysegul Simsek, PhD
-
コンタクト：
- Aysegul Simsek, PhD
- 電話番号：+905413155774
- メール：asimsek@marmara.edu.tr
-
-
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:
- Written and verbal parental consent for participation
- Gestational age between 32 and 36 weeks
- Birth weight of 1500 g or greater
- Apgar score of 6 or greater at 1 and 5 minutes
- Postnatal age of 3 days or older
- Hospitalization in the neonatal intensive care unit for more than 24 hours
- No sedation
- No procedures such as peripheral intravenous catheter insertion, blood sampling, or aspiration within 1 hour before enrollment
- Clinically stable condition
Exclusion Criteria:
- Central nervous system problems such as intracranial hemorrhage, seizures, or hypertonia
- Congenital or genetic anomalies
- Receiving phototherapy
- Respiratory distress requiring oxygen support
- Receiving mechanical ventilation
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Eye Covering
Preterm infants will receive eye covering beginning 15 minutes before nasogastric tube insertion. The eye covering will remain in place during the procedure and for 15 minutes after the procedure. |
Eye covering will be applied 15 minutes before nasogastric tube insertion and will remain in place during the procedure and for 15 minutes after the procedure. |
|
実験的：White Noise
Preterm infants will receive white noise at 45 dB beginning 15 minutes before nasogastric tube insertion. White noise will continue during the procedure and for 15 minutes after the procedure. |
White noise at 45 dB will be started 15 minutes before nasogastric tube insertion and will continue during the procedure and for 15 minutes after the procedure. |
|
実験的：Eye Covering and White Noise
Preterm infants will receive both eye covering and white noise beginning 15 minutes before nasogastric tube insertion. Both interventions will continue during the procedure and for 15 minutes after the procedure. |
Eye covering and white noise at 45 dB will be applied together beginning 15 minutes before nasogastric tube insertion. Both interventions will continue during the procedure and for 15 minutes after the procedure. |
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 |
|---|---|---|
|
Neonatal Comfort Level Assessed Using the COMFORTneo Scale
時間枠：5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
|
Neonatal comfort will be assessed using the COMFORTneo Scale before, during, and after nasogastric tube insertion. COMFORTneo is used to assess comfort and distress in neonates. |
5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Neonatal Pain and Stress Assessed Using the ALPS-Neo Scale
時間枠：5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
|
Neonatal pain and stress will be assessed using the ALPS-Neo Neonatal Pain and Stress Assessment Scale before, during, and after nasogastric tube insertion. |
5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
|
|
Heart Rate
時間枠：5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
|
Heart rate will be measured using a pulse oximeter and recorded as beats per minute. |
5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
|
|
Respiratory Rate
時間枠：5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
|
Respiratory rate will be measured and recorded as breaths per minute. |
5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
|
|
Oxygen Saturation
時間枠：5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
|
Peripheral oxygen saturation will be measured using a pulse oximeter and recorded as a percentage. |
5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Aysegul Simsek, PhD、Marmara University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
その他の研究ID番号
- AS-NICU-NG-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。