Effect of Maternal Voice on Pain, Sedation, and Physiological Parameters in Mechanically Ventilated Children
The Effect of Maternal Voice Played to Children on Mechanical Ventilators on Pain, Sedation, and Physiological Parameters: A Randomized Controlled Trial
調査の概要
詳細な説明
This randomized controlled trial will be conducted in the Pediatric Intensive Care Unit (PICU) of Kayseri City Hospital. Eligible children (aged 1-3 years, intubated, mechanically ventilated, and sedated, with no change in sedation dose in the prior 24 hours) will be assigned to an intervention or control group using stratified block randomization (stratified by age, sex, diagnosis duration, and COMFORT scale score), with simple randomization within blocks performed by an independent researcher.
In the intervention group, each child's mother will be asked to read a children's storybook aloud in a quiet room, and this reading will be recorded (approximately 10 minutes). The recording will then be played to the child once, through wireless over-ear headphones at a safe volume (50-55 dB), during a single morning session. The COMFORT Scale and physiological parameters (heart rate, oxygen saturation, blood pressure, respiratory rate) will be assessed before, during, and after the recording is played. All sessions will be video recorded so that COMFORT Scale scores can also be scored by independent, blinded observers.
Children in the control group will receive standard unit care with no additional intervention, and will be assessed on the same schedule and with the same tools as the intervention group.
Data will be analyzed using IBM SPSS 27.0. Group comparisons will use Chi-square, Independent/Paired Samples t-tests, or Mann-Whitney U/Wilcoxon tests as appropriate, with statistical significance set at p < 0.05.
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：GAMZE NUR GÜZEL, RN
- 電話番号：+905535664246
- メール：gmznrgzl446@gmail.com
研究場所
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Kayseri
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Kayseri、Kayseri、トルコ（Türkiye）
- Kayseri City Hospital
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コンタクト：
- GAMZE NUR GÜZEL, RN
- 電話番号：+905535664246
- メール：gmznrgzl446@gmail.com
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コンタクト：
- MERAL BAYAT, PhD
- 電話番号：+905336504292
- メール：mbayat@erciyes.edu.tr
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Children aged 1-3 years, intubated and mechanically ventilated under sedation
- No change in sedation dose within the last 24 hours
- No hearing impairment in the child
- Parent has no visual, hearing, or speech impairment
- Parent is a Turkish speaker/reader with at least a primary school education
- Parent provides written and verbal informed consent
Exclusion Criteria:
- Children receiving care/treatment due to surgical operation or trauma
- Children who experience cardiac arrest during the study
- Children whose parent withdraws consent during the study
- Children who are extubated during the study
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Maternal Voice Intervention Group
Children received a single ~10-minute recording of their mother's voice reading a children's storybook, played once through wireless over-ear headphones at 50-55 dB during a single morning session, with no other interventions during playback.
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A single ~10-minute audio recording of the child's own mother reading a children's storybook ("The Invisible String," Turkish edition) will be played once through wireless over-ear headphones at a safe listening level (50-55 dB), during a single morning session (10:00-12:00), with no other procedural interventions during playback. The recording will be made in a quiet room by an independent researcher using a digital audio recorder. Want to be notified when Claude responds? |
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介入なし：Control Group
Children received standard PICU care with no additional intervention.
Assessments (COMFORT Scale, physiological parameters, video recording) were performed on the same schedule as the intervention group.
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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 |
|---|---|---|
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COMFORT Scale
時間枠：Assessed before (~5 min), during (~10 min), and immediately after (~5 min) the intervention, within a single ~20-minute session on the day of enrollment
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The COMFORT Scale (full behavioral and physiological scale for assessing pain and sedation level in critically ill children) assesses eight items - alertness, calmness, respiratory response, physical movement, blood pressure, heart rate, muscle tone, and facial tension - each scored 1 to 5, yielding a total score ranging from 8 (minimum) to 40 (maximum).
Higher scores indicate greater distress/pain and inadequate sedation, while lower scores indicate deeper sedation and better comfort.
Scores will be compared between the maternal voice intervention group and the control group.
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Assessed before (~5 min), during (~10 min), and immediately after (~5 min) the intervention, within a single ~20-minute session on the day of enrollment
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協力者と研究者
スポンサー
捜査官
- スタディチェア：MERAL BAYAT, PhD、TC Erciyes 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
追加の関連 MeSH 用語
その他の研究ID番号
- 2025/607
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?
IPD プランの説明
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
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