- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07299214
Музыка во время нестрессового тестирования
Влияние музыки во время нестрессового тестирования на комфорт женщин, показатели жизненно важных функций и тревожность: рандомизированное контролируемое исследование
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.
Обзор исследования
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Central
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Karaman, Central, Турция (Туркие), 70200
- University District, 2076 Street, No: 11
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
|
Без вмешательства: Control Group
Pregnant women were not subjected to any intervention during the NST procedure. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
During Non-Stress Testing on Women's Comfort Level
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- KMBU-NST-2025-01
- 2169 (Ethics decision number) (Другой идентификатор: Non-Interventional Clinical Research Ethics Committee of the Republic of Türkiye Izmir Bakırçay University)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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