ChildbirthComparisonNCT07652957
Comparison Of The Effects Of Swedish Massage With Natural Oils
A study testing Aromatherapy and Massage Care for labor pain management in people with Childbirth and Aromatherapy, run by Kutahya Health Sciences University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childbirth, Aromatherapy, Pain Management
- What is being tested?
- Aromatherapy and Massage Care for labor pain management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 24 Jul 2024to 19 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Antalya City Hospital
Antalya, Center, 06000
Antalya City Hospital
Antalya, Center, 43000
About this study
Official title: 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.
Read the detailed description
This randomized controlled trial was conducted to evaluate the effects of Swedish massage combined with chamomile oil or lavender oil during the first and second stages of labor. Participants were randomly allocated to three groups: chamomile oil with Swedish massage, lavender oil with Swedish massage, and carrier oil with Swedish massage. Outcome measures included labor pain, anxiety, childbirth fear, maternal vital signs, duration of labor stages, and selected maternal and neonatal birth outcomes. Data were collected at predefined stages of labor using validated assessment tools.
- Conditions
- Childbirth, Aromatherapy, Pain Management, Fear, Anxiety, Midwifery
- Being tested
- Aromatherapy and Massage Care for labor pain management
- Keywords
- Pain, labor, childbirth fear, lavender oil, Chamomile oil, Swedish massage, aromatherapy
- Medical subject headings
- Agnosia, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy and Massage Care for labor pain managementOther
Also called Aromatherapy Care Chamomile oil and swedish massage, Swedish massage and basic oil, Aromatherapy Care Lavender oil and swedish massage
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention A, | Experimental | 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. Receives: Other: Aromatherapy and Massage Care for labor pain management |
| Intervention B, | Experimental | 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. Receives: Other: Aromatherapy and Massage Care for labor pain management |
| Intervention C | Experimental | 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. Receives: Other: Aromatherapy and Massage Care for labor pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor pain intensity Visual Analog Scale
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.
Measured: During Childbirth ( to 24 hours)
Secondary outcomes (3)
State anxiety level, state and trait anxiety scale I
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.
Measured: 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
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.
Measured: Duration of first and second stage of labor servical opening 6-10 cm (up to 4 hours)
Delivery Fear Scale
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.
Measured: During the first and second stages of labor. (up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start24 Jul 2024
- Primary completion14 Jan 2025
- Study completion19 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChildbirthStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomise controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya Tosun, Kutahya Health Sciences University
- Investigators
- Hulya t Tosun, Phd. FM., Principal investigator, Kutahya Health Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652957
- Sponsor's protocol ID
- E-95961207-202.3.02-402
- Acronym
- Comparison
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
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 at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07652957
- Acronym / sponsor ID
- Comparison / E-95961207-202.3.02-402
- Conditions
- Childbirth, Aromatherapy, Pain Management, Fear, Anxiety, Midwifery
- Keywords
- Pain, labor, childbirth fear, lavender oil, Chamomile oil, Swedish massage, aromatherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 14 Jan 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized controlled trial was conducted to evaluate the effects of Swedish massage combined with chamomile oil or lavender oil during the first and second stages of labor. Participants were randomly allocated to three groups: chamomile oil with Swedish massage, lavender oil with Swedish massage, and carrier oil with Swedish massage. Outcome measures included labor pain, anxiety, childbirth fear, maternal vital signs, duration of labor stages, and selected maternal and neonatal birth outcomes. Data were collected at predefined stages of labor using validated assessment tools.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomise controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention A, | Experimental | Other: Aromatherapy and Massage Care for labor pain managementIntervention 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. |
| Intervention B, | Experimental | Other: Aromatherapy and Massage Care for labor pain managementIntervention 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. |
| Intervention C | Experimental | Other: Aromatherapy and Massage Care for labor pain managementControl (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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Voluntarily participate in the study and provide written consent.
Key exclusion criteria (4 listed)
- Having a medical, psychiatric, or obstetric condition that could negatively affect the safety/validity of participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aromatherapy and Massage Care for labor pain managementAlso: Aromatherapy Care Chamomile oil and swedish massage, Swedish massage and basic oil, Aromatherapy Care Lavender oil and swedish massageAlthough 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 | Intervention A,, Intervention B,, Intervention C |
Primary outcome
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.
3 secondary outcomes
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)
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)
Delivery Fear Scale
Time frame: During the first and second stages of labor. (up to 24 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Results publicationDurmaz 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 . : . .
- ArticleLink provided by the sponsor.
- https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jspLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hulya t Tosun, Phd. FM. principal investigator
Kutahya Health Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy and Massage Care for labor pain management in people with Childbirth and Aromatherapy, run by Kutahya Health Sciences University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labor pain intensity Visual Analog Scale (time frame: During Childbirth ( to 24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07652957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.