Effect of ASMR and White Noise on Sleep Quality in Patients Undergoing Elective Lower Extremity Surgery (SLEEP-ASMR)
Effect of ASMR and White Noise on Sleep Quality in Patients Undergoing Elective Lower Extremity Surgery: A Randomized Controlled Trial
調査の概要
状態
詳細な説明
Sleep disturbance is one of the most common postoperative complications following orthopedic surgery and is associated with increased pain perception, delayed recovery, prolonged hospitalization, and decreased patient comfort. Non-pharmacological interventions that improve sleep quality may contribute positively to postoperative recovery and patient outcomes.
Autonomous Sensory Meridian Response (ASMR) is characterized by relaxing sensory experiences triggered by auditory stimuli and has recently gained attention for its potential effects on sleep and emotional well-being. White noise is another auditory intervention commonly used to reduce environmental noise perception and promote sleep quality. Although previous studies have demonstrated beneficial effects of ASMR and white noise separately, there is limited evidence comparing these interventions in postoperative orthopedic patients.
This study is designed as a three-arm parallel randomized controlled trial conducted in patients undergoing elective lower extremity surgery. Eligible participants will be randomized in a 1:1:1 ratio into ASMR, white noise, or control groups using computer-generated block randomization. Participants in the intervention groups will listen to standardized 30-minute audio recordings before sleep during the postoperative hospitalization period. The control group will receive headphones without audio playback to minimize environmental noise exposure.
The primary outcome of the study is postoperative sleep quality measured using the Richards-Campbell Sleep Questionnaire (RCSQ). Secondary outcomes may include postoperative pain intensity, nocturnal awakening frequency, and patient comfort. Blinded researchers will perform outcome assessment and statistical analyses.
The findings of this study are expected to provide evidence regarding effective non-pharmacological nursing interventions to improve postoperative sleep quality in orthopedic surgery patients.
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：Müzeyyen Ataseven, PhD, RN
- 電話番号：+905052299474
- メール：muzeyyenataseven@hotmail.com
研究場所
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Istanbul、トルコ（Türkiye）、34810
- Fatih Sultan Mehmet Training and Research Hospital
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コンタクト：
- Müzeyyen Ataseven, PhD, RN
- 電話番号：+905052299474
- メール：muzeyyenataseven@hotmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18 years and older
- Undergoing elective lower extremity surgery
- Conscious and able to communicate
- No hearing impairment or hearing aid use
- Numeric Rating Scale (NRS) pain score of 5 or lower
- No use of medications affecting sleep
- Willing to participate in the study
- Able to provide written informed consent
Exclusion Criteria:
- Participation in another clinical study
- Surgery due to trauma
- Transfer to the intensive care unit during the postoperative period
- Development of serious postoperative complications
- Withdrawal from the study at any stage
- Failure to comply with study procedures
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：ASMR Group
Participants will listen to standardized 30-minute ASMR audio recordings before sleep during the postoperative hospitalization period.
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Standardized ASMR audio recordings administered for 30 minutes before sleep during the postoperative period.
他の名前：
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実験的：White Noise Group
Participants will listen to standardized 30-minute white noise audio recordings before sleep during the postoperative hospitalization period.
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Standardized white noise audio recordings administered for 30 minutes before sleep during the postoperative period.
他の名前：
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介入なし：Control Group
Participants will receive routine postoperative care and will wear headphones without audio playback before sleep.
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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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Postoperative Sleep Quality
時間枠：Postoperative nights 1 and 2
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Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ).
The RCSQ is a validated five-item visual analog scale evaluating sleep depth, sleep latency, number of awakenings, sleep efficiency, and overall sleep quality.
Each item is scored between 0 and 100, and higher scores indicate better sleep quality.
Total scores are calculated by averaging the item scores.
Sleep quality will be evaluated during postoperative nights 1 and 2.
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Postoperative nights 1 and 2
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Müzeyyen Ataseven, PhD,RN、Medipol 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
- ASMR-2026
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
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。
睡眠の質の臨床試験
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University Hospital, Clermont-Ferrand積極的、募集していないMSProgress Qualityアプローチサポートツールの影響の評価標準ケアと比較して、MSPが選択したインジケーターの進化に及ぼすツールフランス
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Fujian Shengdi Pharmaceutical Co., Ltd.募集
ASMR Audio Interventionの臨床試験
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Huazhong University of Science and Technology完了
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
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University of MichiganNational Institute on Drug Abuse (NIDA)完了
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University of PittsburghCenters for Disease Control and Prevention募集暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ