- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07652957
Comparison Of The Effects Of Swedish Massage With Natural Oils (Comparison)
Comparison Of The Effects Of Swedish Massage With Natural Oils During The 1st And 2nd Stages Of Labor On Labor Pain, Fear And Anxiety Levels: A Randomized Controlled Study
Aim: This study aimed to evaluate the effects of Swedish massage combined with lavender and chamomile oils on childbirth outcomes during the first and second stages of labor.
Materials and Methods: This randomized controlled experimental study was conducted with 90 pregnant women. Participants were randomly assigned to three groups: Intervention A (n=30; carrier oil + chamomile oil + Swedish massage), Intervention B (n=30; carrier oil + lavender oil + Swedish massage), and Control (n=30; carrier oil + Swedish massage). Data were collected using the Individual Identification Form, Vital Signs (blood pressure and pulse), Partograph, Visual Analog Scale (VAS) for pain, State-Trait Anxiety Inventory (STAI-I and STAI-II), and the Childbirth Fear Scale. Statistical analyses were performed using IBM SPSS Statistics Version 23.0.
The study was designed to compare the effects of Swedish massage combined with chamomile oil, lavender oil, or carrier oil on labor pain, anxiety, childbirth fear, physiological parameters, and selected birth outcomes during the first and second stages of labor.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Center
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Antalya, Center, Турция (Туркие), 06000
- Antalya City Hospital
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Antalya, Center, Турция (Туркие), 43000
- Antalya City Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
• Voluntarily participate in the study and provide written consent.
- Ability to communicate and follow instructions.
- Possess a general health/obstetric status sufficient to safely complete the research process.
- No known allergies to aromatherapy inhalation or skin reactions.
Exclusion Criteria:
Having a medical, psychiatric, or obstetric condition that could negatively affect the safety/validity of participation.
- Being unsuitable for intervention due to conditions requiring acute/chronic treatment.
- Using painkillers/sedatives, etc., that could affect the study results
- Showing hypersensitivity to herbal/essential oils or carrier ingredients.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Intervention A,
Intervention A (n=30; carrier oil + chamomile oil + Swedish massage), Stage I: From cervical dilation of 4 cm to 8 cm, four 10-minute sessions of labor massage were performed using superficial tapping techniques (for the head, shoulders, hands, and feet). Stage II: From 8 cm dilation to delivery, petrissage or strong tapping massage (B-shaped and heart-shaped), petrissage to the head and shoulders, spiral vibration to both sides of the vertebral column, and sacrum compression were applied four times for 20 minutes each. In each stage, the expectant mother was asked to indicate the area where she felt pain using the "Pain Area Drawings" chart. The type and intensity of the massage were determined based on the severity of the pain and the mother's emotional needs. |
Although lavender and chamomile oils have been used in midwifery practices in previous studies, no study has been found comparing the effects of Swedish massage
Другие имена:
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Экспериментальный: Intervention B,
Intervention B (n=30; carrier oil + lavender oil + Swedish massage) Stage I: From cervical dilation of 4 cm to 8 cm, four 10-minute sessions of labor massage were performed using superficial tapping techniques (for the head, shoulders, hands, and feet) Stage II: From 8 cm dilation to delivery, petrissage or strong tapping massage (B-shaped and heart-shaped), petrissage to the head and shoulders, spiral vibration to both sides of the vertebral column, and sacrum compression were applied four times for 20 minutes each. In each stage, the expectant mother was asked to indicate the area where she felt pain using the "Pain Area Drawings" chart. The type and intensity of the massage were determined based on the severity of the pain and the mother's emotional needs. |
Although lavender and chamomile oils have been used in midwifery practices in previous studies, no study has been found comparing the effects of Swedish massage
Другие имена:
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Экспериментальный: Intervention C
Control (n=30; carrier oil + Swedish massage).Stage I: From cervical dilation of 4 cm to 8 cm, four 10-minute sessions of labor massage were performed using superficial tapping techniques (for the head, shoulders, hands, and feet). Stage II: From 8 cm dilation to delivery, petrissage or strong tapping massage (B-shaped and heart-shaped), petrissage to the head and shoulders, spiral vibration to both sides of the vertebral column, and sacrum compression were applied four times for 20 minutes each. In each stage, the expectant mother was asked to indicate the area where she felt pain using the "Pain Area Drawings" chart. The type and intensity of the massage were determined based on the severity of the pain and the mother's emotional needs. |
Although lavender and chamomile oils have been used in midwifery practices in previous studies, no study has been found comparing the effects of Swedish massage
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Labor pain intensity Visual Analog Scale
Временное ограничение: During Childbirth ( to 24 hours)
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Measurement tool: Visual Analog Scale Measurement time: 4 cm, 8 cm, 10 cm cervical dilation and immediately after delivery. The scale is a 10 cm long scale used to assess pain intensity. Scores range from 0-100; higher scores indicate more severe pain. |
During Childbirth ( to 24 hours)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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State anxiety level, state and trait anxiety scale I
Временное ограничение: Duration of first and second stage of labor servical opening 4-6 cm (up to 6 hours)
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The scale consists of two subscales that measure state and trait anxiety.
Each subscale comprises 20 items, with scores ranging from 20 to 80. Higher scores indicate a higher level of anxiety.
The Cronbach's alpha coefficients for the Turkish form are between 0.83 and 0.87 for State anxiety level I and between 0.86 and 0.92 for Trait anxiety level.
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Duration of first and second stage of labor servical opening 4-6 cm (up to 6 hours)
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Trait anxiety level, state and trait anxiety scale II
Временное ограничение: Duration of first and second stage of labor servical opening 6-10 cm (up to 4 hours)
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State-Trait Anxiety Inventory-State Form II, a 20-item self-report instrument.
Each item is rated on a 4-point Likert scale.
Total scores range from 20 to 80, with higher scores indicating greater state anxiety.
The instrument has demonstrated good reliability, with reported Cronbach's alpha values ranging from 0.83 to 0.87 in Turkish validation studies.
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Duration of first and second stage of labor servical opening 6-10 cm (up to 4 hours)
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Delivery Fear Scale
Временное ограничение: During the first and second stages of labor. (up to 24 hours)
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Fear of childbirth will be assessed using the Delivery Fear Scale, a 10-item self-report instrument developed to measure fear experienced during labor.
Each item is scored from 1 to 10, resulting in a total score ranging from 10 to 100.
Higher scores indicate greater fear of childbirth.
The Turkish version of the scale demonstrated excellent internal consistency with a Cronbach's alpha coefficient of 0.90.
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During the first and second stages of labor. (up to 24 hours)
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Соавторы и исследователи
Следователи
- Главный следователь: Hulya t Tosun, Phd. FM., Kutahya Health Science University
Публикации и полезные ссылки
Общие публикации
- Durmaz Fatma Cigdem Sirin, Tosun Hülya, Özlü Aysun COMPARISON OF THE EFFECTS OF SWEDISH MASSAGE WITH NATURAL OILS DURING THE 1ST AND 2ND STAGES OF LABOR ON LABOR PAIN, FEAR AND ANXIETY LEVELS: A RANDOMIZED CONTROLLED STUDY . : . .
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
- Неврологические проявления
- Заболевания нервной системы
- Психические расстройства
- Нейроповеденческие проявления
- Расстройства восприятия
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Боль
- Тревожные расстройства
- Агнозия
- Терапия
- Терапия разума и тела
- Дополнительная терапия
- Неорганические химические вещества
- Психотерапия
- Поведенческие дисциплины и деятельность
- Сенсорная художественная терапия
- Фитотерапия
- Ароматерапия
- Alkalies
Другие идентификационные номера исследования
- E-95961207-202.3.02-402
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Данные исследования/документы
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Протокол исследования
Информационный идентификатор: Fatma Cigdem Sirin DurmazИнформационные комментарии: If the data would like, the researchers will send to researchers
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.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .