Exploring the Effect of Aromatherapy

December 10, 2025 updated by: Baptist Health South Florida

Exploring the Effect of Aromatherapy Inhalation for Managing Pain, Anxiety, and Nausea/Vomiting Throughout the Laboring Process

To explore the effect of aromatherapy in laboring patients with pain, anxiety, and/or nausea/vomiting.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33143
        • South Miami Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• Pregnant patients at least 18 years old in spontaneous labor or induction of labor (despite transitioning into a caesarean section)

Exclusion Criteria:

  • Patients who are unable to detect scents/odors
  • Patients with known allergies to aromatherapy and/or its components

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group: Education video
The participant receives aromatherapy plus standard of care (SoC) for treatment based on symptoms (anxiety, pain, and/or nausea/vomiting) as prescribed by the physician.
Other: Aromatherapy plus standard of care

The participant is offered an aromatherapy scented tab that is attached to their gown based on symptoms (anxiety, pain, and/or nausea/vomiting):

  1. Pain or anxiety: lavender or lavender sandalwood,
  2. Nausea/vomiting: orange ginger, or
  3. Despite the type of discomfort, the participant may request the alternate scent if the scent offered is not to their liking.

Plus, the patient receives SoC for treatment based on symptoms (anxiety, pain, and/or nausea/vomiting) as prescribed by the physician.
Other: Control group: Standard of Care
The patient receives SoC for treatment of based on symptoms (anxiety, pain, and/or nausea/vomiting) as prescribed by the physician.
Other: Standard of Care Only
Participant receives symptom management medications for pain, nausea/vomiting, and/or anxiety as prescribed by the physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relief of nausea/vomiting
Time Frame: Measured before and after receiving standard of care (SoC) or Intervention+SoC.
Measured in the control and intervention groups before and after receiving treatment (yes or no - presence of nausea/vomiting).
Measured before and after receiving standard of care (SoC) or Intervention+SoC.
Decreased anxiety
Time Frame: Measured before and after receiving standard of care (SoC) or Intervention+SoC.
Measured before and after receiving treatment in both the control and intervention groups. Anxiety level = 0 =none, 1 = minimal (a little), 2 = moderate (medium), and 3 = severe (a lot).
Measured before and after receiving standard of care (SoC) or Intervention+SoC.
Pain relief (scale of 0 to 10)
Time Frame: Measured before and after receiving standard of care (SoC) or Intervention+SoC.
Level of pain is measured before and after receiving treatment in both the control and interventions groups. Pain is measured on a scale of 0 to 10 (0 = no pain, 10 = severe pain).
Measured before and after receiving standard of care (SoC) or Intervention+SoC.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baptist Health South Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 14, 2025

First Submitted That Met QC Criteria

August 26, 2025

First Posted (Estimated)

September 4, 2025

Study Record Updates

Last Update Posted (Actual)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2298893

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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