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Aromatherapy

Experimental for Procedural Pain

Phase 2

Waitlist Available

Led By Tiffani-Amber Miller, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes

Awards & highlights

Study Summary

This trial showed that using lavender aromatherapy during office hysteroscopy can help reduce stress and anxiety levels in patients compared to using a placebo.

Who is the study for?

This trial is for women over 18 who are scheduled for an office hysteroscopy, can consent, read and write in English, and have some anxiety about the procedure. It's not for those allergic to lavender or with conditions that make hysteroscopy risky like severe infections or certain cancers.Check my eligibility

What is being tested?

The study tests if lavender aromatherapy (using Lavandula angustifolia oil by Aura Cacia) can reduce stress and pain during a hysteroscopy compared to a placebo (distilled water). Participants' anxiety levels will be measured using questionnaires.See study design

What are the potential side effects?

Lavender aromatherapy is generally considered safe but may cause mild skin irritation or allergic reactions in sensitive individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine change in anxiety scores from baseline to immediate post-procedure.

Determine level of satisfaction after the procedure

Determine the change in pain scores from baseline to immediate post-procedure.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment1 Intervention

Prior to starting the procedure, the clinic nurse will prepare the aromatherapy Lavender essential oil on a paper towel by applying two drops of each solution on a paper towel. The patients will hold the paper towel over their nose and then they will be asked to take two deep breaths. Before the physician comes in, the nurse will ask the participant to take a deep breath while holding the towel 3 inches from her face and will instruct the participant to continue to take normal breaths subsequently

Group II: PlaceboPlacebo Group1 Intervention

Prior to starting the procedure, the clinic nurse will prepare the distilled water on a paper towel by applying two drops of each solution on a paper towel. The patients will hold the paper towel over their nose and then they will be asked to take two deep breaths. Before the physician comes in, the nurse will ask the participant to take a deep breath while holding the towel 3 inches from her face and will instruct the participant to continue to take normal breaths subsequently

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,638 Total Patients Enrolled

Tiffani-Amber Miller, MDPrincipal InvestigatorUniversity of Florida

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which specific criteria must individuals meet in order to be considered eligible for participation in this clinical study?

"Individuals aged between 18 and 99 experiencing procedural pain are eligible to participate in this study, which aims to enroll approximately 30 participants."

Answered by AI

Does this study include individuals above the age of 40?

"Individuals aged 18 and above up to 99 years old are eligible for enrollment based on the trial's inclusion criteria."

Answered by AI

Are new participants currently being accepted for this research study?

"According to clinicaltrials.gov, this particular investigation is not actively recruiting participants. Despite being posted on 3/1/2024 and last updated on 3/16/2024, it is presently closed for enrollment. However, there are currently 721 alternative trials seeking patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lavender Aromatherapy to Decrease Anxiety/Pain Perception During Office Hysteroscopy

Tiffani-Amber Miller 2024. "Lavender Aromatherapy to Decrease Anxiety/Pain Perception During Office Hysteroscopy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06316934.