Effects of Aromatherapy on Patient Satisfaction With Surgical Abortion at Less Than 10 Weeks Gestation

The investigators propose a single-site, double-blinded, placebo-controlled clinical trial of lavender aromatherapy versus placebo for patient satisfaction in adult women having a surgical abortion before 10 weeks and 0 days gestation. The investigators will evaluate whether lavender aromatherapy is an effective adjunct therapy for patient satisfaction during first trimester surgical abortion. The investigators will measure satisfaction using the Iowa Satisfaction with Anesthesia Scale (ISAS). The investigators hypothesize that women receiving lavender aromatherapy will report higher satisfaction scores compared to women receiving placebo.

Prior studies have investigated the use of aromatherapy in laboring patients, in menstruating women, and in general post-operative populations. No investigations have focused on the use of lavender aromatherapy as an adjunct therapy to paracervical block and/or oral narcotics and anxiolytics in outpatient surgical abortion. Our study is novel in investigating patient satisfaction with first trimester surgical abortion using lavender aromatherapy.

The contribution of this proposed research to the literature is significant because current affordable anesthetic adjuncts to opioids and benzodiazepines are limited.

Study Overview

• Status: Completed
• Conditions: Pain; Anesthesia; Patient Satisfaction; Surgical Abortion
• Intervention / Treatment: Other: Placebo oil; Other: Lavender oil.

Detailed Description

The investigators propose a single-site, double-blinded, placebo-controlled clinical trial of lavender aromatherapy versus placebo for patient satisfaction in adult women having a surgical abortion before 10 weeks and 0 days gestation. The investigators will evaluate whether lavender aromatherapy is an effective adjunct therapy for patient satisfaction during first trimester surgical abortion. The investigators will measure satisfaction using the Iowa Satisfaction with Anesthesia Scale (ISAS). The investigators hypothesize that women receiving lavender aromatherapy will report higher satisfaction scores compared to women receiving placebo.

Prior studies have investigated the use of aromatherapy in laboring patients, in menstruating women, and in general post-operative populations. No investigations have focused on the use of lavender aromatherapy as an adjunct therapy to paracervical block and/or oral narcotics and anxiolytics in outpatient surgical abortion. This study is novel in investigating patient satisfaction with first trimester surgical abortion using lavender aromatherapy.

The contribution of this proposed research to the literature is significant because current affordable anesthetic adjuncts to opioids and benzodiazepines are limited.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80230
      • Comprehensive Women's Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women18 years or older
• Have decide to have a pregnancy termination with no sedation or oral sedation.
• Are less than10 weeks 0 days gestational age with viable pregnancy.
• Agree to being randomized to aromatherapy or placebo

Exclusion Criteria:

• Contraindications or allergies to ibuprofen, lidocaine, or jojoba oil.
• A non-viable intrauterine pregnancy
• A pregnancy greater than or equal to 10 weeks gestational age.
• Adults who are unable to consent or who are currently incarcerated.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo - Jojoba Oil (100% organic golden expeller-pressed Simmondsia chinensis); Study randomization to lavender aromatherapy or placebo will occur just prior to the initiation of the abortion procedure. A permutated block stratified randomization scheme will be utilized so that equal numbers of participants receiving no sedation and PO sedation will be randomized to lavender aromatherapy or placebo. 1cc of dilute lavender aromatherapy and placebo will be pre-filled in a 5/8 dram mini amber glass bottle provided to the patient. Immediately prior to procedure start (defined as after receiving antibiotic and emptying bladder), participants will be instructed to self-administer the study product. They will bring down their personal cloth mask to chin level and rub the study product within the amber glass bottle on their upper lip and nose (left and right ala, alarfacial grooves, and columella). Participants will be instructed to take 4 deep breaths and then replace their mask over their nose. The patient will then proceed to the procedure.	Other: Placebo oil; The placebo group will receive placebo oil.
Active Comparator: Investigational Product - A 10% dilute Lavandula angustifolia - jojoba oil essential oil blend; Study randomization to lavender aromatherapy or placebo will occur just prior to the initiation of the abortion procedure. A permutated block stratified randomization scheme will be utilized so that equal numbers of participants receiving no sedation and PO sedation will be randomized to lavender aromatherapy or placebo. 1cc of dilute lavender aromatherapy and placebo will be pre-filled in a 5/8 dram mini amber glass bottle provided to the patient. Immediately prior to procedure start (defined as after receiving antibiotic and emptying bladder), participants will be instructed to self-administer the study product. They will bring down their personal cloth mask to chin level and rub the study product within the amber glass bottle on their upper lip and nose (left and right ala, alarfacial grooves, and columella). Participants will be instructed to take 4 deep breaths and then replace their mask over their nose. The patient will then proceed to the procedure.	Other: Lavender oil.; Investigational Product. This group will receive Lavender oil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction With Anesthesia	Difference in patient satisfaction with their abortion experience as measured on the Iowa Satisfaction with Anesthesia Scale (ISAS) following a surgical abortion less than 10 weeks 0 days gestational age between women randomized to lavender aromatherapy versus placebo. The self-reported questionnaire consists of 11 items such as "I hurt," "I felt safe," "I had nausea," each assessed on a Likert-type scale ranging from "Disagree very much" to "Agree very much." The responses are then scored from -3 (least satisfied) to +3 (most satisfied) and an average composite score is obtained.	15 minutes post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Procedural Pain	Difference in maximum procedural pain as measured by Visual Analog Scale (VAS) in patients receiving lavender aromatherapy versus placebo. The VAS is presented as a 100-millimeter line with descriptive anchors at each end, "no pain" on the left at 0 centimeters and "pain as bad as it could be" at 100-millimeters. Respondents place a vertical line through the point on the scale that best fits their experience with their procedural pain and that mark is measured as a continuous variable for pain from 0 to 10 (no pain to pain as bad as it could be).	Immediately post-procedure
Acceptability	Patient acceptability of lavender aromatherapy as a complementary and alternative medicine used during first trimester surgical abortion as measured through a post-procedure survey.	11 months
Patient Acceptability of Lavender Aromatherapy in Procedural Abortion	We asked: Agreed inhaling scented was helpful during procedure, Would recommend inhaling scented oil to a friend who needed a procedural abortion, If needed another procedural abortion, would want to inhale scented oil during procedure. Participants' acceptability was measured on a 5-point Likert scale (strongly agree, somewhat agree, neither agree or disagree, somewhat disagree, strongly disagree). With strongly agree being a better outcome. Participants who agree with outcome include those who somewhat agree and strongly agree.	15 minutes post-procedure

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Leanne Free, MD, University of Colorado, Denver

Publications and helpful links

Helpful Links

• Guttmacher Institute. "Induced Abortion in the United States," May 3, 2016.
• First-Trimester Surgical Abortion Practices: A Survey of National Abortion Federation Members
• Micks, Elizabeth A., Alison B. Edelman, Regina Maria Renner, Rongwei Fu, William E. Lambert, Paula H. Bednarek, Mark D. Nichols, Ethan H. Beckley, and Jeffrey T. Jensen. "Hydrocodone-Acetaminophen for Pain Control in First-Trimester Surgical Abortion:
• Ndubisi, Chioma, Antoinette Danvers, Melanie A. Gold, Lisa Morrow, and Carolyn L. Westhoff. "Auricular Acupuncture as an Adjunct for Pain Management during First Trimester Abortion: A Randomized, Double-Blinded, Three Arm Trial." Contraception 99, no.
• schann, Mary, Jennifer Salcedo, Reni Soon, and Bliss Kaneshiro. "Patient Choice of Adjunctive Nonpharmacologic Pain Management during First-Trimester Abortion: A Randomized Controlled Trial." Contraception 98, no. 3 (September 1, 2018): 205-9.
• Tanvisut, Rajavadi, Kuntharee Traisrisilp, and Theera Tongsong. "Efficacy of Aromatherapy for Reducing Pain during Labor: A Randomized Controlled Trial." Archives of Gynecology and Obstetrics 297, no. 5 (May 2018): 1145-50
• Upchurch, Dawn M., and Laura Chyu. "Use of Complementary and Alternative Medicine among American Women." Women's Health Issues 15, no. 1 (January 2005): 5-13.
• "Dexter - 2012 - Iowa Satisfaction with Anesthesia Scale.Pdf." Accessed August 24, 2020.
• Dexter, Franklin. "Iowa Satisfaction with Anesthesia Scale." Korean Journal of Anesthesiology 62, no. 3 (2012): 297.
• Dexter, Franklin, John Aker, and Will A. Wright. "Development of a Measure of Patient Satisfaction with Monitored Anesthesia Care: The Iowa Satisfaction with Anesthesia Scale." Anesthesiology 87, no. 4 (October 1997): 865-73.
• enner, Sallie Stoltz. "Lavandula Angustifolia Miller: English Lavender." Holistic Nursing Practice 23, no. 1 (January 2009): 57-64.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2021
• Primary Completion (Actual): April 26, 2022
• Study Completion (Actual): April 26, 2022

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 21-2561

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