- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Center
-
Antalya, Center, Turkey (Türkiye), 06000
- Antalya City Hospital
-
Antalya, Center, Turkey (Türkiye), 43000
- Antalya City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
Other Names:
|
|
Experimental: 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
Other Names:
|
|
Experimental: 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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Labor pain intensity Visual Analog Scale
Time Frame: During Childbirth ( to 24 hours)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State anxiety level, state and trait anxiety scale I
Time Frame: Duration of first and second stage of labor servical opening 4-6 cm (up to 6 hours)
|
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.
|
Duration of first and second stage of labor servical opening 4-6 cm (up to 6 hours)
|
|
Trait anxiety level, state and trait anxiety scale II
Time Frame: Duration of first and second stage of labor servical opening 6-10 cm (up to 4 hours)
|
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.
|
Duration of first and second stage of labor servical opening 6-10 cm (up to 4 hours)
|
|
Delivery Fear Scale
Time Frame: During the first and second stages of labor. (up to 24 hours)
|
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.
|
During the first and second stages of labor. (up to 24 hours)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hulya t Tosun, Phd. FM., Kutahya Health Science University
Publications and helpful links
General Publications
- 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 . : . .
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Anxiety Disorders
- Agnosia
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Inorganic Chemicals
- Psychotherapy
- Behavioral Disciplines and Activities
- Sensory Art Therapies
- Phytotherapy
- Aromatherapy
- Alkalies
Other Study ID Numbers
- E-95961207-202.3.02-402
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Study Data/Documents
-
Study Protocol
Information identifier: Fatma Cigdem Sirin DurmazInformation comments: If the data would like, the researchers will send to researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
University of CalabriaNot yet recruitingAnxiety | Anxiety Disease | Anxiety and Distress | Public Speaking AnxietyItaly
-
Clinica Alemana de SantiagoUniversidad del DesarrolloRecruitingAnxiety | Induction of Anesthesia | Anxiety Preoperative | Technology Use | Child Anxiety | Anesthesia Care | Anxiety After SurgeryChile
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; Boston University; Johns Hopkins... and other collaboratorsCompletedAnxiety Disorders | Anxiety | Anxiety Symptoms | Child Anxiety | Anxiety, Mild to Moderate | Pediatric Anxiety DisordersUnited States
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Abant Izzet Baysal UniversityRecruitingAnxiety | Parental AnxietyTurkey (Türkiye)
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiActive, not recruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Florida State UniversityRecruitingAnxiety | Generalized Anxiety Disorder (GAD) | WorryingUnited States
-
Institut National de la Santé Et de la Recherche...Active, not recruitingAnxiety Disorders | Anxiety | Anxiety and FearFrance
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
Clinical Trials on Aromatherapy and Massage Care for labor pain management
-
University Tunis El ManarHypnoVREnrolling by invitation
-
Royal Marsden NHS Foundation TrustCompletedPain | Unspecified Adult Solid Tumor, Protocol Specific | Psychosocial Effects of Cancer and Its TreatmentUnited Kingdom
-
Case Western Reserve UniversityUniversity of California, San Diego; Albert Einstein College of Medicine; Vanderbilt... and other collaboratorsCompletedAcute Pain | Pain Management | Acupuncture | Emergency DepartmentUnited States
-
Massachusetts General HospitalCompleted
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingChronic Pain | Cancer PainUnited States
-
Jordan Miller, PT, PhDUniversity Hospitals Kingston Foundation - Women's Giving CircleCompleted
-
Nilgün ErdoğanRecruitingDiabetes Mellitus, Type 2 | Pulmonary Disease, Chronic Obstructive | Respiratory Insufficiency | Stroke, Ischemic | High Blood PressureTurkey
-
Hong Kong Metropolitan UniversityThe University of Hong Kong; The Hong Kong Polytechnic University; Health and... and other collaboratorsActive, not recruitingChronic Pain | Elderly | Informal Caregivers | Dyadic InterventionHong Kong
-
Shahid Beheshti University of Medical SciencesNot yet recruitingPain Management | Nursing Education | Knowledge, Attitudes, PracticeIran
-
Helsinki University Central HospitalCompleted