- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Center
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Antalya, Center, Turecko (Türkiye), 06000
- Antalya City Hospital
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Antalya, Center, Turecko (Türkiye), 43000
- Antalya City Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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
Ostatní jména:
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Experimentální: 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
Ostatní jména:
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Experimentální: 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
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Labor pain intensity Visual Analog Scale
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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State anxiety level, state and trait anxiety scale I
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Hulya t Tosun, Phd. FM., Kutahya Health Science University
Publikace a užitečné odkazy
Obecné publikace
- 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 . : . .
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Neurologické projevy
- Nemoci nervového systému
- Duševní poruchy
- Neurobehaviorální projevy
- Poruchy vnímání
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Bolest
- Úzkostné poruchy
- Agnosia
- Terapeutika
- Terapie mysli a těla
- Doplňkové terapie
- Anorganické chemikálie
- Psychoterapie
- Disciplíny a činnosti chování
- Smyslové umělecké terapie
- Fytoterapie
- Aromaterapie
- Alkalies
Další identifikační čísla studie
- E-95961207-202.3.02-402
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
Studijní data/dokumenty
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Protokol studie
Identifikátor informace: Fatma Cigdem Sirin DurmazKomentáře k informacím: If the data would like, the researchers will send to researchers
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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