- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Center
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Antalya, Center, Turcja (Türkiye), 06000
- Antalya City Hospital
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Antalya, Center, Turcja (Türkiye), 43000
- Antalya City Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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
Inne nazwy:
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Eksperymentalny: 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
Inne nazwy:
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Eksperymentalny: 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
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Labor pain intensity Visual Analog Scale
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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State anxiety level, state and trait anxiety scale I
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Śledczy
- Główny śledczy: Hulya t Tosun, Phd. FM., Kutahya Health Science University
Publikacje i pomocne linki
Publikacje ogólne
- 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 . : . .
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Objawy neurologiczne
- Choroby Układu Nerwowego
- Zaburzenia psychiczne
- Manifestacje neurobehawioralne
- Zaburzenia percepcyjne
- Stany patologiczne, oznaki i objawy
- Objawy i symptomy
- Ból
- Zaburzenia lękowe
- Agnozja
- Lecznictwo
- Terapie umysłowe
- Terapie uzupełniające
- Chemikalia nieorganiczne
- Psychoterapia
- Dyscypliny i działania behawioralne
- Terapie sztuki sensoryczne
- Fitoterapia
- Aromaterapia
- Alkalies
Inne numery identyfikacyjne badania
- E-95961207-202.3.02-402
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
Badanie danych/dokumentów
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Protokół badania
Identyfikator informacji: Fatma Cigdem Sirin DurmazKomentarze do informacji: If the data would like, the researchers will send to researchers
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Lęk
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Peking UniversityAktywny, nie rekrutującyZaburzenia lękowe | Znajomość zdrowia psychicznego | Anxiety LiteracyChiny