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非負荷試験中の音楽

2026年10月16日 更新者:GAMZE GOKE ARSLAN、Karamanoğlu Mehmetbey University

非ストレステスト中の音楽が女性の快適さ、バイタルサイン、不安に及ぼす影響:無作為化比較試験

Music has direct and indirect positive effects on the mother and fetus during pregnancy and perinatal period. This study was aimed at investigating effects of music played during the Non-Stress Test (NST) procedure on the mother's comfort, vital signs and anxiety.

調査の概要

状態

完了

研究の種類

介入

入学 (実際)

173

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Central
      • Karaman、Central、トルコ(Türkiye)、70200
        • University District, 2076 Street, No: 11

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~45年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

説明

Inclusion Criteria:

  • Women aged 18-45 years
  • Completion of at least the 32nd week of gestation
  • No pregnancy-related risk factors (e.g., premature rupture of membranes, preeclampsia, gestational diabetes)
  • No multiple pregnancy
  • Normal blood pressure levels (not ≤80/60 mmHg and not ≥140/90 mmHg)
  • Having eaten at least two hours before the NST procedure
  • No smoking or alcohol consumption for at least two hours before the NST procedure
  • Ability to communicate effectively
  • No hearing impairment
  • Voluntary participation in the study

Exclusion Criteria:

  • Pregnant women with fetal distress
  • Cases for whom the physician considered emergency intervention necessary
  • Individuals with an impaired NST requiring immediate intervention
  • Individuals with a diagnosed psychiatric disorder
  • Individuals with hearing impairment

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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: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:Music Group

After the pregnant women were positioned, while the NST procedure was implemented they listened to music for 20-30 minutes. The pregnant women listened to the music on an MP3 player during the application. The duration of the music recorded on the MP3 player was 30 minutes. The music played to the pregnant women was selected by the researchers in accordance with the definition of relaxing music made in the literature. Before the music selection, the researchers communicated with the TÜMATA (Turkish acronym for the "Research and Promotion of Turkish Music Association). After the meeting held with the association, it was decided to use the 'Acemaşiran' (a musical mode in traditional Turkish music). In the study, music prepared by the TÜMATA in the Acemaşiran mode was played. It is stated that Acemaşiran mode helps balance the body, helps the listener relax, facilitates birth, helps correct the wrong position of the fetus in the womb, and has a pain and spasm relieving effect

The music played to the pregnant women was selected by the researchers in accordance with the definition of relaxing music made in the literature. Before the music selection, the researchers communicated with the TÜMATA (Turkish acronym for the "Research and Promotion of Turkish Music Association). After the meeting held with the association, it was decided to use the 'Acemaşiran' (a musical mode in traditional Turkish music). In the study, music prepared by the TÜMATA in the Acemaşiran mode was played. It is stated that Acemaşiran mode helps balance the body, helps the listener relax, facilitates birth, helps correct the wrong position of the fetus in the womb, and has a pain and spasm relieving effect.

介入なし:Control Group

Pregnant women were not subjected to any intervention during the NST 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
During Non-Stress Testing on Women's Comfort Level
時間枠:Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)

Prenatal Comfort Scale (PCS) was used to determine women's comfort level. The short version of the PCS consists of 15 items. Response given to the items are rated on a six-point Likert type scale ranging from 0 to 5 (0 = Strongly disagree, 1 = Disagree, 2 = Undecided, 3 = Somewhat agree, 4 = Agree, 5 = Strongly agree). The minimum and maximum possible scores that can be obtained from the PCS are 0 and 75, respectively. The higher the score is the higher the comfort level is.

Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
During Non-Stress Testing on Women's Systolic Blood Pressure Level
時間枠:Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)

The women's systolic blood pressure levels were measured with a calibrated electronic sphygmomanometer. Blood pressure levels are expressed in millimeters of mercury (mmHg).

Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
During Non-Stress Testing on Women's Diastolic Blood Pressure Level
時間枠:Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)

The women's diastolic blood pressure levels were measured with a calibrated electronic sphygmomanometer. Blood pressure levels are expressed in millimeters of mercury (mmHg).

Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
During Non-Stress Testing on Women's Heart Rate Level
時間枠:Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)

Heart rate level was determined electronically. Heart rate level was recorded in beats per minute (bpm).

Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
During Non-Stress Testing on Women's Anxiety Level
時間枠:Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)

State Anxiety Scale (SAS) was used to determine the anxiety level. The scale is a 4-point Likert type, "not at all" (1), "somewhat" (2), "moderately" (3), "very much" (4). The scale consists of 20 items and items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reverse scored. To calculate the total score of the SAS, the total score of the reversed items is subtracted from the total score of the non-reversed items. Then, 50 points, which is the constant value of the state anxiety scale, are added to this score. The result is the score for the overall SAS. The total score varies between 20 and 80. The higher the score is the higher the level of the anxiety is. While a score ranging between 0 and 19 indicates "no anxiety", a score ranging between 20 and 39 indicates mild anxiety, a score ranging between 40 and 59 indicates moderate anxiety, a score ranging between 60 and 79 indicates severe anxiety, and a score of 80 indicates very severe anxiety (Panic).

Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年6月1日

一次修了 (実際)

2025年8月31日

研究の完了 (実際)

2025年8月31日

試験登録日

最初に提出

2025年11月23日

QC基準を満たした最初の提出物

2025年12月9日

最初の投稿 (実際)

2025年12月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月19日

QC基準を満たした最後の更新が送信されました

2026年10月16日

最終確認日

2026年10月1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

  • KMBU-NST-2025-01
  • 2169 (Ethics decision number) (その他の識別子:Non-Interventional Clinical Research Ethics Committee of the Republic of Türkiye Izmir Bakırçay University)

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?

未定

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

いいえ

米国FDA規制機器製品の研究

いいえ

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