Effectiveness of Aromatherapy in Reducing Anxiety and Pain Perception in Women During Childbirth

NCT06849297 | Active Not Recruiting DMC

• 1 other identifier: KBKA/18/O/2024
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  2 hours postpartum

• Postpartum depression symptoms assessed using the Edinburgh Postnatal Depression Scale (EPDS)

  2 weeks postpartum

Study Arms (2)

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.

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.

Interventions

Aromatherapy during labor BEHAVIORAL

Use of essential oils (diffusion, massage, or infused cloths) during labor to promote relaxation and pain relief.

Aromatherapy Group (Intervention Arm)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only female participants are eligible for this study, as it focuses on the effects of aromatherapy during labor and childbirth, which are exclusive to women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andrzej Frycz Modrzewski Krakow University: lead

Study Sites (1)

Stefan Żeromski Specialist Hospital in Kraków

Krakow, 31-913, Poland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 27, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

PL (1)