Development of a Management Model for Hyperemesis in Pregnant Women Through the "Vibratory Emesis Massage" (VEM)
Development of a Management Model for Hyperemesis in Pregnant Women Through the "Vibratory Emesis Massage" Nursing Intervention at Prof. Chairuddin Panusunan Lubis Hospital, University of North Sumatra
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Hyperemesis gravidarum is a condition characterized by severe nausea and vomiting during pregnancy that may affect nutritional status, fluid balance, and quality of life. Non-pharmacological therapies such as acupressure and massage stimulation have increasingly been used as complementary approaches to reduce symptoms during pregnancy.
This study developed a nursing intervention model called Vibratory Emesis Massage (VEM), which combines vibratory stimulation and acupressure at the Pericardium 6 (P6) point using a wearable wristband device. The intervention was designed to reduce nausea and vomiting symptoms in pregnant women through peripheral nerve stimulation and relaxation mechanisms.
The study used a quasi-experimental pretest-posttest non-equivalent control group design involving 240 pregnant women diagnosed with hyperemesis gravidarum at Prof. Dr. Chairuddin Panusunan Lubis Hospital, University of North Sumatra. Participants were divided into intervention and control groups. The intervention group received Vibratory Emesis Massage therapy for 15-20 minutes per session.
The severity of nausea and vomiting was measured using the Pregnancy Unique Quantification of Emesis (PUQE-24) questionnaire before and after the intervention. Data were analyzed using the Wilcoxon Signed-Rank Test and Mann-Whitney U Test to determine the effectiveness of the intervention.
The study aimed to provide evidence for the effectiveness of Vibratory Emesis Massage as a practical, safe, non-invasive, and nurse-led intervention for managing nausea and vomiting in pregnant women.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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North Sumatra
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Medan, North Sumatra, Индонезия, 20155
- Prof. Dr. Chairuddin Panusunan Lubis Hospital, University of North Sumatra
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Pregnant women diagnosed with emesis gravidarum or hyperemesis gravidarum.
- Gestational age within the first, second, or third trimester (with a focus on those experiencing active nausea and vomiting symptoms).
- Aged between 18 and 45 years.
- Admitted to or receiving care at Prof. Dr. Chairuddin Panusunan Lubis Hospital, University of North Sumatra.
- Willing to participate in the study and capable of providing written informed consent.
Exclusion Criteria:
- Pregnant women with severe medical complications unrelated to hyperemesis (e.g., severe cardiovascular disease, active skin infections, or open wounds at the Pericardium 6 / P6 acupoint area on the wrist).
- Patients receiving concurrent alternative non-pharmacological therapies for nausea and vomiting that could confound the study results.
- Patients who are unable to complete the assigned 15-to-20-minute Vibratory Emesis Massage (MVE) sessions due to acute physical or cognitive distress.
- Participants who choose to withdraw from the hospital treatment or study protocol before the post-test evaluation is completed.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Vibratory Emesis Massage Group
Participants received Vibratory Emesis Massage therapy using a vibratory wristband device applied at the Pericardium 6 (P6) acupoint for approximately 15-20 minutes per session, administered 1-2 times daily in addition to standard nursing care.
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Participants received Vibratory Emesis Massage therapy using a vibratory wristband device applied at the Pericardium 6 (P6) point for approximately 15-20 minutes per session to reduce nausea and vomiting during pregnancy.
Другие имена:
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Без вмешательства: Standard Nursing Care Group
Participants received standard nursing care for hyperemesis gravidarum without Vibratory Emesis Massage intervention.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in the Severity of Nausea and Vomiting Symptoms.
Временное ограничение: Assessed at baseline (pre-test, prior to receiving the device stimulation) and reassessed at the post-test evaluation phase (following the completion of the assigned therapy sessions).
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The frequency and clinical severity of hyperemesis gravidarum are assessed using the researcher-modified Pregnancy Unique Quantification of Emesis (PUQE-24) questionnaire. For clinical macro-level analysis, the continuous index scores are converted into an ordinal scale: Score 1 : Mild category (PUQE index score <6). Score 2 : Moderate category (PUQE index score 7-12) Score 3 : Severe category (PUQE index score >13) |
Assessed at baseline (pre-test, prior to receiving the device stimulation) and reassessed at the post-test evaluation phase (following the completion of the assigned therapy sessions).
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Maternal Demographic and Baseline Clinical Characteristics.
Временное ограничение: Measured once at baseline during the initial participant selection and screening phase.
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Evaluation of baseline participant characteristics using the researcher's modified structured questionnaire to establish descriptive control data.
Recorded categorical variables include: Maternal age (categorized as 18-25, 26-35, or 36-45 years old).
Highest educational attainment (Elementary, Middle School, High School, or College).
Employment status/Occupation (Civil Servant, Self-Employed, or Housewife).
Marriage age, past medical history, gravidity, parity, and the specific stage of pregnancy (First, Second, or Third trimester)
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Measured once at baseline during the initial participant selection and screening phase.
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Device Safety and Treatment Discomfort.
Временное ограничение: Assessed continuously from the first intervention session (Day 1) until completion of the intervention period (Day 3), including monitoring during hospital care and home follow-up visits.
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Continuous researcher observation and participant monitoring for any perceived physical complaints or adverse effects (such as localized wrist pain or skin discomfort) associated with the application of the Vibratory Emesis Massage (VEM) wristband over the Pericardium 6 (P6) acupoint.
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Assessed continuously from the first intervention session (Day 1) until completion of the intervention period (Day 3), including monitoring during hospital care and home follow-up visits.
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Siti Saidah Nasution, S.Kp., M.Kep., Sp.Mat, Universitas Sumatera Utara
Публикации и полезные ссылки
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
- EVM-HG-USU-2026
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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