HealthyNCT06849297
Effectiveness of Aromatherapy in Reducing Anxiety and Pain Perception in Women During Childbirth
A study testing Aromatherapy during labor in people with Healthy, run by Andrzej Frycz Modrzewski Krakow University at 1 site in Poland.
Trial summary
Study Summary Objective of the StudyThis study aims to evaluate the effects of aromatherapy on women's childbirth experiences, particularly in reducing anxiety, alleviating pain, and increasing overall satisfaction with labor. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aromatherapy during labor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 17 Feb 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female participants.
- Minimum age of 18 years.
- Pregnant women between 37 and 42 weeks of gestation.
- Planning a vaginal delivery.
- In overall good health, without pregnancy-related complications.
- Willing to provide informed consent for participation in the study.
- No history of high-risk pregnancy.
- Ability to understand the study procedures and follow instructions.
Who cannot join
- Severe maternal health conditions that may affect labor outcomes.
- High-risk pregnancy requiring medical interventions.
- Presence of fetal congenital anomalies.
- Decision to receive epidural or other pharmacological pain relief.
- Need for medical intervention during labor (e.g., cesarean section, forceps, vacuum extraction).
- Known allergies or adverse reactions to essential oils.
- Inability to provide informed consent due to cognitive impairment or language barriers.
- Presence of chronic respiratory conditions that may be affected by inhaled essential oils.
Trial locations and contacts
1 site in 1 country.
About this study
Study Summary
Objective of the StudyThis study aims to evaluate the effects of aromatherapy on women's childbirth experiences, particularly in reducing anxiety, alleviating pain, and increasing overall satisfaction with labor. The research seeks to explore whether aromatherapy can serve as an effective, non-pharmacological method to improve comfort during childbirth.
Read more
Research QuestionDoes the use of aromatherapy during labor reduce pain intensity, lower anxiety levels, and enhance maternal satisfaction compared to standard obstetric care?
HypothesisIt is hypothesized that the use of aromatherapy during labor helps to decrease anxiety, lessen labor pain, and improve the overall birth experience without negatively affecting the health of the mother or newborn.
Brief Description of the StudyThis study is a randomized controlled clinical trial conducted at the Stefan Żeromski Specialist Hospital in Kraków. It will include women who are delivering vaginally between 37-42 weeks of gestation. Participants will be randomly assigned to either a group receiving aromatherapy (using essential oils such as lavender, clary sage, and lemon) or a control group receiving standard obstetric care without aromatherapy.
The effectiveness of aromatherapy will be assessed based on pain perception, anxiety levels, labor duration, and newborn condition. The study aims to provide scientific evidence on the benefits of aromatherapy in labor, potentially contributing to its broader adoption in maternity care.
Read the detailed description
Study Summary Study Objective The objective of this study is to evaluate the impact of aromatherapy on women's childbirth experiences, including anxiety reduction, pain perception, and overall satisfaction with the delivery process. Given the increasing interest in non-pharmacological pain and stress relief methods during labor, this study aims to provide reliable scientific data on the effectiveness of aromatherapy as a supportive method for laboring women.
Research Question Does the use of aromatherapy during labor reduce labor pain, lower anxiety levels, and improve overall satisfaction with the childbirth experience compared to standard obstetric care? Research Hypothesis It is hypothesized that the use of aromatherapy during labor leads to reduced anxiety levels, decreased intensity of labor pain, and increased satisfaction with the childbirth experience, without adverse effects on maternal and neonatal health.
Study Description
This is a randomized controlled clinical trial conducted at the Labor and Delivery Ward of the Stefan Żeromski Specialist Hospital in Kraków. Women delivering vaginally between 37-42 weeks of gestation will be included. Participants will be randomly assigned to one of two groups:
- Experimental Group - use of aromatherapy during labor, including diffusion of essential oils, inhalation, or massage with patient-selected oils (e.g., lavender, clary sage, lemon, geranium, peppermint).
- Control Group - standard obstetric care without the use of aromatherapy. Methods for Evaluating Aromatherapy Effectiveness
- Pain assessment using the Visual Analogue Scale (VAS).
- Anxiety level assessment using the Childbirth Anxiety Questionnaire (KLP II).
- Analysis of childbirth satisfaction using the Childbirth Experience Questionnaire (QACE).
- Evaluation of the impact of aromatherapy on labor duration and perineal incision rates.
- Neonatal assessment using the Apgar score and determining the need for hospitalization in the Neonatal Pathology Unit.
- Postpartum depression assessment two weeks after birth using the Edinburgh Postnatal Depression Scale (EPDS).
Detailed Study Description Study Design The study is designed as a randomized controlled clinical trial (RCT) with double-blinded allocation to study groups. Randomization will be performed using a computer algorithm, and group assignment will remain concealed until the intervention begins.
Study Procedure The study is divided into three phases: the preliminary phase, the main study phase, and the data analysis phase.
- Preliminary Phase - Adaptation of research tools to Polish conditions, pilot tests, and training of medical personnel.
- Main Study Phase - Conducting the study according to protocol, participant enrollment, and data collection.
- Analysis Phase - Statistical data analysis and interpretation of results. Intervention In the experimental group, doTERRA essential oils will be used, selected based on patient preferences and medical indications. Possible application methods include diffusion, inhalation, and massage.
Data Collection Methods
Data will be collected at multiple stages:
- Upon study enrollment (demographic questionnaire, medical history).
- During labor (VAS pain assessment, KLP II anxiety measurements).
- After childbirth (QACE childbirth satisfaction assessment, neonatal Apgar scores).
- Two weeks postpartum (EPDS postpartum depression assessment). Study Significance The results are expected to provide scientific evidence on the effectiveness of aromatherapy in reducing labor pain and anxiety. The study findings may contribute to the widespread implementation of aromatherapy as a standard supportive method in obstetric care.
- Conditions
- Healthy
- Being tested
- Aromatherapy during labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy during laborBehavioural
Use of essential oils (diffusion, massage, or infused cloths) during labor to promote relaxation and pain relief.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy Group (Intervention Arm) | Experimental | Participants will receive aromatherapy during labor, using essential oils as recommended by medical staff and based on individual preferences. The laboring woman will choose the type of oil and method of application. Before use, a midwife will inform her about the properties and application methods of essential oils.
Possible aromatherapy applications during labor:
* Diffusion: Dispersing essential oils in the air using a diffuser to create a relaxing atmosphere. Oils like lavender, geranium, and mandarin may help reduce tension and anxiety.
* Massage: Essential oils mixed with a carrier oil (e.g., coconut or almond) can be used for gentle massage of the back, arms, or feet to ease muscle tension and discomfort.
* Infused cloths: Essential oil-soaked cloths or compresses can be used for inhalation. The woman can hold the cloth near her nose during contractions to aid relaxation.
The medical staff will offer different essential oils depending on the woman's preferences. Receives: Behavioral: Aromatherapy during labor |
| Control Group (Standard Care Arm) | No intervention | Participants in this group will receive standard obstetric care without the use of aromatherapy. All routine childbirth procedures will be applied according to hospital protocols. This arm serves as the baseline for comparing the effectiveness of aromatherapy against standard care in terms of pain management, anxiety reduction, and childbirth satisfaction. Randomization will ensure equal distribution of participants into both arms to enable an objective comparison of the outcomes associated with aromatherapy versus standard obstetric care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity during labor measured by Visual Analog Scale (VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable. Measurements will be taken multiple times: at 3 cm, 6 cm, and 9 cm cervical dilation, Pain scores will be compared between the aromatherapy and control groups.
Measured: At cervical dilation of 3 cm, 6 cm, and 9 cm,
Secondary outcomes (3)
MMaternal anxiety during labor measured by Childbirth Anxiety Questionnaire (KLP II)
Anxiety levels during labor will be assessed using the Childbirth Anxiety Questionnaire (KLP II). Measurements will be taken approximately 1 hour after the start of aromatherapy in the intervention group. In the control group, anxiety levels will be assessed at the same time point without aromatherapy. Anxiety scores will be compared between both groups.
Measured: 1 hour after the start of aromatherapy (or at the same time point in the control group without aromatherapy).
Maternal satisfaction with childbirth experience measured by QACE (Questionnaire for Assessing the Childbirth Experience)
Overall satisfaction with the childbirth experience will be assessed using the QACE questionnaire. Measurements will be taken 2 hours after birth and compared between the aromatherapy and control groups.
Measured: 2 hours postpartum
Postpartum depression symptoms assessed using the Edinburgh Postnatal Depression Scale (EPDS)
The Edinburgh Postnatal Depression Scale (EPDS) will be used to assess postpartum depression symptoms. A higher score indicates a greater likelihood of postpartum depression. Data will be collected 2 weeks postpartum via an online questionnaire.
Measured: 2 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start17 Feb 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrzej Frycz Modrzewski Krakow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renata Bakalarz, Andrzej Frycz Modrzewski Krakow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849297
- Sponsor's protocol ID
- KBKA/18/O/2024
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently, we have not made a final decision about sharing individual participant data (IPD). The decision to share data will depend on factors such as obtaining ethical approvals, participant consent for data sharing, as well as ensuring adequate privacy protection and data anonymization procedures. The final determination will be made in accordance with institutional policies and ethical standards following the completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Aromatherapy in Reducing Anxiety and Pain Perception in Women During Childbirth
- ClinicalTrials.gov ID
- NCT06849297
- Acronym / sponsor ID
- KBKA/18/O/2024
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Andrzej Frycz Modrzewski Krakow UniversityUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 27 Feb 2025 (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.
Study Summary
Objective of the StudyThis study aims to evaluate the effects of aromatherapy on women's childbirth experiences, particularly in reducing anxiety, alleviating pain, and increasing overall satisfaction with labor. The research seeks to explore whether aromatherapy can serve as an effective, non-pharmacological method to improve comfort during childbirth.
Research QuestionDoes the use of aromatherapy during labor reduce pain intensity, lower anxiety levels, and enhance maternal satisfaction compared to standard obstetric care?
HypothesisIt is hypothesized that the use of aromatherapy during labor helps to decrease anxiety, lessen labor pain, and improve the overall birth experience without negatively affecting the health of the mother or newborn.
Brief Description of the StudyThis study is a randomized controlled clinical trial conducted at the Stefan Żeromski Specialist Hospital in Kraków. It will include women who are delivering vaginally between 37-42 weeks of gestation. Participants will be randomly assigned to either a group receiving aromatherapy (using essential oils such as lavender, clary sage, and lemon) or a control group receiving standard obstetric care without aromatherapy.
The effectiveness of aromatherapy will be assessed based on pain perception, anxiety levels, labor duration, and newborn condition. The study aims to provide scientific evidence on the benefits of aromatherapy in labor, potentially contributing to its broader adoption in maternity care.
Detailed description
Study Summary Study Objective The objective of this study is to evaluate the impact of aromatherapy on women's childbirth experiences, including anxiety reduction, pain perception, and overall satisfaction with the delivery process. Given the increasing interest in non-pharmacological pain and stress relief methods during labor, this study aims to provide reliable scientific data on the effectiveness of aromatherapy as a supportive method for laboring women.
Research Question Does the use of aromatherapy during labor reduce labor pain, lower anxiety levels, and improve overall satisfaction with the childbirth experience compared to standard obstetric care? Research Hypothesis It is hypothesized that the use of aromatherapy during labor leads to reduced anxiety levels, decreased intensity of labor pain, and increased satisfaction with the childbirth experience, without adverse effects on maternal and neonatal health.
Study Description
This is a randomized controlled clinical trial conducted at the Labor and Delivery Ward of the Stefan Żeromski Specialist Hospital in Kraków. Women delivering vaginally between 37-42 weeks of gestation will be included. Participants will be randomly assigned to one of two groups:
- Experimental Group - use of aromatherapy during labor, including diffusion of essential oils, inhalation, or massage with patient-selected oils (e.g., lavender, clary sage, lemon, geranium, peppermint).
- Control Group - standard obstetric care without the use of aromatherapy. Methods for Evaluating Aromatherapy Effectiveness
- Pain assessment using the Visual Analogue Scale (VAS).
- Anxiety level assessment using the Childbirth Anxiety Questionnaire (KLP II).
- Analysis of childbirth satisfaction using the Childbirth Experience Questionnaire (QACE).
- Evaluation of the impact of aromatherapy on labor duration and perineal incision rates.
- Neonatal assessment using the Apgar score and determining the need for hospitalization in the Neonatal Pathology Unit.
- Postpartum depression assessment two weeks after birth using the Edinburgh Postnatal Depression Scale (EPDS).
Detailed Study Description Study Design The study is designed as a randomized controlled clinical trial (RCT) with double-blinded allocation to study groups. Randomization will be performed using a computer algorithm, and group assignment will remain concealed until the intervention begins.
Study Procedure The study is divided into three phases: the preliminary phase, the main study phase, and the data analysis phase.
- Preliminary Phase - Adaptation of research tools to Polish conditions, pilot tests, and training of medical personnel.
- Main Study Phase - Conducting the study according to protocol, participant enrollment, and data collection.
- Analysis Phase - Statistical data analysis and interpretation of results. Intervention In the experimental group, doTERRA essential oils will be used, selected based on patient preferences and medical indications. Possible application methods include diffusion, inhalation, and massage.
Data Collection Methods
Data will be collected at multiple stages:
- Upon study enrollment (demographic questionnaire, medical history).
- During labor (VAS pain assessment, KLP II anxiety measurements).
- After childbirth (QACE childbirth satisfaction assessment, neonatal Apgar scores).
- Two weeks postpartum (EPDS postpartum depression assessment). Study Significance The results are expected to provide scientific evidence on the effectiveness of aromatherapy in reducing labor pain and anxiety. The study findings may contribute to the widespread implementation of aromatherapy as a standard supportive method in obstetric care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy Group (Intervention Arm) | Experimental | Behavioral: Aromatherapy during laborParticipants will receive aromatherapy during labor, using essential oils as recommended by medical staff and based on individual preferences. The laboring woman will choose the type of oil and method of application. Before use, a midwife will inform her about the properties and application methods of essential oils. Possible aromatherapy applications during labor: * Diffusion: Dispersing essential oils in the air using a diffuser to create a relaxing atmosphere. Oils like lavender, geranium, and mandarin may help reduce tension and anxiety. * Massage: Essential oils mixed with a carrier oil (e.g., coconut or almond) can be used for gentle massage of the back, arms, or feet to ease muscle tension and discomfort. * Infused cloths: Essential oil-soaked cloths or compresses can be used for inhalation. The woman can hold the cloth near her nose during contractions to aid relaxation. The medical staff will offer different essential oils depending on the woman's preferences. |
| Control Group (Standard Care Arm) | No intervention | –Participants in this group will receive standard obstetric care without the use of aromatherapy. All routine childbirth procedures will be applied according to hospital protocols. This arm serves as the baseline for comparing the effectiveness of aromatherapy against standard care in terms of pain management, anxiety reduction, and childbirth satisfaction. Randomization will ensure equal distribution of participants into both arms to enable an objective comparison of the outcomes associated with aromatherapy versus standard obstetric care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female participants.
- Minimum age of 18 years.
- Pregnant women between 37 and 42 weeks of gestation.
- Planning a vaginal delivery.
- In overall good health, without pregnancy-related complications.
Key exclusion criteria (8 listed)
- Severe maternal health conditions that may affect labor outcomes.
- High-risk pregnancy requiring medical interventions.
- Presence of fetal congenital anomalies.
- Decision to receive epidural or other pharmacological pain relief.
- Need for medical intervention during labor (e.g., cesarean section, forceps, vacuum extraction).
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 during laborUse of essential oils (diffusion, massage, or infused cloths) during labor to promote relaxation and pain relief. | Behavioural | Aromatherapy Group (Intervention Arm) |
Primary outcome
Pain intensity during labor measured by Visual Analog Scale (VAS)
Time frame: At cervical dilation of 3 cm, 6 cm, and 9 cm,
Pain intensity will be assessed using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable. Measurements will be taken multiple times: at 3 cm, 6 cm, and 9 cm cervical dilation, Pain scores will be compared between the aromatherapy and control groups.
3 secondary outcomes
MMaternal anxiety during labor measured by Childbirth Anxiety Questionnaire (KLP II)
Time frame: 1 hour after the start of aromatherapy (or at the same time point in the control group without aromatherapy).
Maternal satisfaction with childbirth experience measured by QACE (Questionnaire for Assessing the Childbirth Experience)
Time frame: 2 hours postpartum
Postpartum depression symptoms assessed using the Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 2 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: Undecided. Currently, we have not made a final decision about sharing individual participant data (IPD). The decision to share data will depend on factors such as obtaining ethical approvals, participant consent for data sharing, as well as ensuring adequate privacy protection and data anonymization procedures. The final determination will be made in accordance with institutional policies and ethical standards following the completion of the study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy during labor in people with Healthy, run by Andrzej Frycz Modrzewski Krakow University at 1 site in Poland.
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 8 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain intensity during labor measured by Visual Analog Scale (VAS) (time frame: At cervical dilation of 3 cm, 6 cm, and 9 cm,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2025.