Exploring the Effect of Aromatherapy
1 other identifier
interventional
128
1 country
1
Brief Summary
To explore the effect of aromatherapy in laboring patients with pain, anxiety, and/or nausea/vomiting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable anxiety
Started Oct 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2025
CompletedFirst Posted
Study publicly available on registry
September 4, 2025
CompletedStudy Start
First participant enrolled
October 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
December 17, 2025
August 1, 2025
11 months
August 14, 2025
December 10, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Relief of nausea/vomiting
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
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)
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.
Study Arms (2)
Intervention group: Education video
EXPERIMENTALThe participant receives aromatherapy plus standard of care (SoC) for treatment based on symptoms (anxiety, pain, and/or nausea/vomiting) as prescribed by the physician.
Control group: Standard of Care
OTHERThe patient receives SoC for treatment of based on symptoms (anxiety, pain, and/or nausea/vomiting) as prescribed by the physician.
Interventions
Participant receives symptom management medications for pain, nausea/vomiting, and/or anxiety as prescribed by the physician.
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.
Eligibility Criteria
You may qualify if:
- Pregnant patients at least 18 years old in spontaneous labor or induction of labor (despite transitioning into a caesarean section)
You may not qualify if:
- Patients who are unable to detect scents/odors
- Patients with known allergies to aromatherapy and/or its components
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Miami Hospital
Miami, Florida, 33143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2025
First Posted
September 4, 2025
Study Start
October 15, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
December 17, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share