Stefan Żeromski Specialist Hospital in Kraków
Krakow, 31-913, Poland
NCT Number: NCT06849297
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
Female
Interventional
Not applicable
Krakow, 31-913, Poland
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:
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.
Data Collection Methods
Data will be collected at multiple stages:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of essential oils (diffusion, massage, or infused cloths) during labor to promote relaxation and pain relief.
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.
Time frame: 1 hour after the start of aromatherapy (or at the same time point in the control group without aromatherapy).
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.
Time frame: 2 hours postpartum
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.
Time frame: 2 weeks postpartum
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.
Andrzej Frycz Modrzewski Krakow University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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