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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pain, Surgical Abortion, Patient Satisfaction, Anesthesia

Intervention / Treatment
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* Other: Placebo oil
* Other: Lavender oil.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo - Jojoba Oil (100% organic golden expeller-pressed Simmondsia chinensis)<br>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<br>* The placebo group will receive placebo oil.<br>|
| Active Comparator: Investigational Product - A 10% dilute Lavandula angustifolia - jojoba oil essential oil blend<br>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.<br>* Investigational Product. This group will receive Lavender oil.<br>|

What is the study measuring?
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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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction Based on Baseline Anxiety | Difference in patient satisfaction based on baseline state and trait anxiety as measured by the State Trait Anxiety Inventory (STAI) in those who received lavender aromatherapy. | 1 year | 
| Difference in Patient Satisfaction Based on Sedation | Difference in patient satisfaction in those who receive oral sedation compared to those who receive no sedation, in patients receiving lavender aromatherapy versus placebo. Satisfaction is measured through a 3-item post-procedure questionnaire with Likert scale responses ranging from Strongly Agree to Strongly Disagree | 1 year | 
| 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 10-centimeter line with descriptive anchors at each end, no pain on the left at 0 centimeters and pain as bad as it could be at 10 centimeters. 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). | 1 year | 
| 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. | 1 year |