Clinical trial NCT06849297: Effectiveness of Aromatherapy in Reducing Anxiety and Pain Perception in Women During Childbirth
Official title: Effectiveness of Aromatherapy in Reducing Anxiety and Pain Perception in Women During Childbirth
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Andrzej Frycz Modrzewski Krakow University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain intensity during labor measured by Visual Analog Scale (VAS)
timeFrame: At cervical dilation of 3 cm, 6 cm, and 9 cm,
Secondary outcomes:
measure: MMaternal anxiety during labor measured by Childbirth Anxiety Questionnaire (KLP II)
timeFrame: 1 hour after the start of aromatherapy (or at the same time point in the control group without aromatherapy).
measure: Maternal satisfaction with childbirth experience measured by QACE (Questionnaire for Assessing the Childbirth Experience)
timeFrame: 2 hours postpartum
measure: Postpartum depression symptoms assessed using the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 2 weeks postpartum
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Stefan Żeromski Specialist Hospital in Kraków
Study officials:
References: