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

NCT04969900 | Completed Results

• 1 other identifier: 21-2561
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Abortion; Patient Satisfaction; Anesthesia; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Maximum Procedural Pain

  Immediately post-procedure

• Acceptability

  11 months

• Patient Acceptability of Lavender Aromatherapy in Procedural Abortion

  15 minutes post-procedure

Study Arms (2)

Placebo - Jojoba Oil (100% organic golden expeller-pressed Simmondsia chinensis)

PLACEBO COMPARATOR

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

Investigational Product - A 10% dilute Lavandula angustifolia - jojoba oil essential oil blend

ACTIVE COMPARATOR

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.

Interventions

Placebo oil OTHER

The placebo group will receive placebo oil.

Placebo - Jojoba Oil (100% organic golden expeller-pressed Simmondsia chinensis)

Lavender oil. OTHER

Investigational Product. This group will receive Lavender oil.

Investigational Product - A 10% dilute Lavandula angustifolia - jojoba oil essential oil blend

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Enrollment is limited to patients undergoing a pregnancy termination; therefore, all subjects must be female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Comprehensive Women's Health Center

Denver, Colorado, 80230, United States

Location

Related Publications (1)

• Free LL, Sheeder J, Cohen RH. Effects of aromatherapy on patient satisfaction with procedural abortion at less than 10 weeks' gestation: A randomized controlled trial. Contraception. 2024 Feb;130:110311. doi: 10.1016/j.contraception.2023.110311. Epub 2023 Oct 17.

  PMID: 37858617 DERIVED

Related 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.
• Effects of Aromatherapy Acupressure on Hemiplegic Shoulder Pain and Motor Power in Stroke Patients: A Pilot Study.
• enner, Sallie Stoltz. "Lavandula Angustifolia Miller: English Lavender." Holistic Nursing Practice 23, no. 1 (January 2009): 57-64.
• 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.

MeSH Terms

Conditions

Patient Satisfaction; Pain

Interventions

lavender oil

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Leanne Free
• Organization: Principal Investigator

leanne.free@cuanschutz.edu

303-724-8576

Study Officials

• Leanne Free, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: For purposes of masking, all patients enrolled in the study will be required to wear a cloth face covering over their nose and mouth during their procedure to minimize diffusion of the aromatic scent in the procedure room.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-site, double-blinded, placebo-controlled clinical trial of lavender aromatherapy versus inert oil placebo for patient satisfaction in adult women having a first trimester outpatient surgical abortion before 10 weeks and 0 days gestation.

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 21, 2021
• Study Start: May 13, 2021
• Primary Completion: April 26, 2022
• Study Completion: April 26, 2022
• Last Updated: August 3, 2025
• Results First Posted: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)