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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo oil | Other | The placebo group will receive placebo oil. |
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| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
Enrollment is limited to patients undergoing a pregnancy termination; therefore, all subjects must be female.
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| Name | Affiliation | Role |
|---|---|---|
| Leanne Free, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Women's Health Center | Denver | Colorado | 80230 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37858617 | Derived | 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. |
| Label | URL |
|---|---|
| Guttmacher Institute. "Induced Abortion in the United States," May 3, 2016. | View source |
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From May 2021 through April 2022, we assessed 196 participants for eligibility. We excluded 51 potential participants, the majority of whom declined to participate. Of 144 participants consented and enrolled, 73 were randomized to aromatherapy and 71 were randomized to placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis) | Study randomization to lavender aromatherapy or placebo occurred just prior to the initiation of the abortion procedure. A permutated block stratified randomization scheme was utilized so that equal numbers of participants receiving no sedation and PO sedation were 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 were instructed to self-administer the study product. They brought 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 were instructed to take 4 deep breaths and then replace their mask over their nose. The patient then proceeded to the procedure. Placebo oil: The placebo group received jojoba oil. |
| FG001 | Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend | Study randomization to lavender aromatherapy or placebo occurred just prior to the initiation of the abortion procedure. A permutated block stratified randomization scheme was utilized so that equal numbers of participants receiving no sedation and PO sedation were 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 were instructed to self-administer the study product. They brought 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 were instructed to take 4 deep breaths and then replace their mask over their nose. The patient then proceeded to the procedure. Lavender oil: Investigational Product. This group received a 10% lavandula angustafolia diluted in jojoba oil. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
32 participants were excluded from analysis: 30 were enrolled prior to posting the study on ClinicalTrials.gov; 1 had an undiagnosed ectopic pregnancy, and one had a protocol deviation (did not receive study product).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Lavender oil.: Investigational Product. This group will receive Lavender oil. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 32 participants were excluded from analysis: 30 were enrolled prior to posting the study on ClinicalTrials.gov; 1 had an undiagnosed ectopic pregnancy, and one had a protocol deviation (did not receive study product). | Posted | Mean | Standard Deviation | score on a scale | 15 minutes post-procedure |
|
Adverse event data were collect only on the day of the procedure; from time of enrollment into the study until discharge from the clinic.
32 participants were excluded from analysis: 30 were enrolled prior to posting the study on ClinicalTrials.gov; 1 had an undiagnosed ectopic pregnancy, and one had a protocol deviation (did not receive study product).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis) | Study randomization to lavender aromatherapy or placebo occurred just prior to the initiation of the abortion procedure. A permutated block stratified randomization scheme was utilized so that equal numbers of participants receiving no sedation and PO sedation were 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 were instructed to self-administer the study product. They brought 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 were instructed to take 4 deep breaths and then replace their mask over their nose. The patient then proceeded to the procedure. Placebo oil: The placebo group received jojoba oil. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leanne Free | Principal Investigator | 303-724-8576 | leanne.free@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2022 | Apr 5, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C045718 | lavender oil |
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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.
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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.
| Lavender oil. | Other | Investigational Product. This group will receive Lavender oil. |
|
| 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 |
| First-Trimester Surgical Abortion Practices: A Survey of National Abortion Federation Members | View source |
| 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: | View source |
| 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. | View source |
| 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. | View source |
| enner, Sallie Stoltz. "Lavandula Angustifolia Miller: English Lavender." Holistic Nursing Practice 23, no. 1 (January 2009): 57-64. | View source |
| 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 | View source |
| 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. | View source |
| "Dexter - 2012 - Iowa Satisfaction with Anesthesia Scale.Pdf." Accessed August 24, 2020. | View source |
| Dexter, Franklin. "Iowa Satisfaction with Anesthesia Scale." Korean Journal of Anesthesiology 62, no. 3 (2012): 297. | View source |
| 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. | View source |
| BG001 | 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. Placebo oil: The placebo group will receive placebo oil. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| History of | Count of Participants | Participants |
|
| Highest Level of Education | There were 3 non-responders in the aromatherapy group and 1 in the placebo group | Count of Participants | Participants |
|
| Pain with Menses Visual Analog Scale | Baseline menstrual pain was assessed using an unmarked 100mm visual analog scale (VAS) with anchors at 0mm indicating "no pain" and 100mm indicating "severe pain." | Median | Full Range | units on a scale |
|
| Adjusted State Trait Anxiety Iventory | Additionally, participants completed the State-Trait Anxiety Inventory (STAI) [15], a 40-item self-reported questionnaire to measure current state of anxiety and overall anxiety proneness. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always") with higher scores indicating greater anxiety. The presence of state or trait anxiety was determined using a cut-off score of 40 which defines a probable clinical diagnosis of anxiety | Median | Full Range | units on a scale |
|
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. Lavender oil.: Investigational Product. This group will receive Lavender oil. |
| OG001 | 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. Placebo oil: The placebo group will receive placebo oil. |
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| Secondary | 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). | 32 participants were excluded from analysis: 30 were enrolled prior to posting the study on ClinicalTrials.gov; 1 had an undiagnosed ectopic pregnancy, and one had a protocol deviation (did not receive study product). | Posted | Median | Full Range | millimeters | Immediately post-procedure |
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|
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| Secondary | 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. | During analysis, participants who "neither agreed or disagreed" were considered not satisfied. | Posted | Count of Participants | Participants | 11 months |
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| Secondary | 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. | During analysis, participants who "neither agreed or disagreed" were considered not satisfied. | Posted | Count of Participants | Participants | 15 minutes post-procedure |
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| 0 |
| 71 |
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend | Study randomization to lavender aromatherapy or placebo occurred just prior to the initiation of the abortion procedure. A permutated block stratified randomization scheme was utilized so that equal numbers of participants receiving no sedation and PO sedation were 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 were instructed to self-administer the study product. They brought 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 were instructed to take 4 deep breaths and then replace their mask over their nose. The patient then proceeded to the procedure. Lavender oil: Investigational Product. This group received a 10% lavandula angustafolia diluted in jojoba oil. | 0 | 73 | 0 | 73 | 0 | 73 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| If needed another procedural abortion, would want to inhale scented oil during procedure |
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| If needed another procedural abortion, would want to inhale scented oil during procedure |
|