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OpenTrials
Completed

NCT Number: NCT04969900

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Comprehensive Women's Health Center

Denver, Colorado, 80230, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo oil

Other

The placebo group will receive placebo oil.

Lavender oil.

Other

Investigational Product. This group will receive Lavender oil.

Primary outcomes

  1. Patient Satisfaction With Anesthesia

    Time frame: 15 minutes post-procedure

    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.

Secondary outcomes

  1. Maximum Procedural Pain

    Time frame: Immediately post-procedure

    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).

  2. Acceptability

    Time frame: 11 months

    Patient acceptability of lavender aromatherapy as a complementary and alternative medicine used during first trimester surgical abortion as measured through a post-procedure survey.

  3. Patient Acceptability of Lavender Aromatherapy in Procedural Abortion

    Time frame: 15 minutes post-procedure

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2021
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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