Anesthesia, Pain, Patient Satisfaction, Surgical Abortion
Conditions
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.
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.
Interventions
OTHERPlacebo oil
The placebo group will receive placebo oil.
OTHERLavender oil.
Investigational Product. This group will receive Lavender oil.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Anesthesia | 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum Procedural Pain | 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). |
| Acceptability | 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. |
| Patient Acceptability of Lavender Aromatherapy in Procedural Abortion | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 57 |
| 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. | 55 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Subjects excluded due to enrollment in study prior to registration on ClinicalTrials.gov. | 15 | 15 |
Baseline characteristics
| Characteristic | Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend | Total | Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis) |
|---|---|---|---|
| Adjusted State Trait Anxiety Iventory State Anxiety - how a person feels in the moment. Min: 20 max: 80. Higher score is more anxiety . | 43 units on a scale | 45 units on a scale | 45 units on a scale |
| Adjusted State Trait Anxiety Iventory Trait Anxiety - how a person generally feels. Min: 20 max: 80. Higher score is more anxiety . | 34 units on a scale | 36 units on a scale | 37 units on a scale |
| Age, Continuous | 27 years | 27 years | 28 years |
| Highest Level of Education Graduated college or graduate school | 24 Participants | 46 Participants | 22 Participants |
| Highest Level of Education Less than college (some college, graduated high school, GED, vocational school) | 30 Participants | 62 Participants | 32 Participants |
| Highest Level of Education Non-responders | 3 Participants | 4 Participants | 1 Participants |
| History of Cesarean Delivery | 5 Participants | 12 Participants | 7 Participants |
| History of Medication Abortion | 7 Participants | 10 Participants | 3 Participants |
| History of Miscarriage | 13 Participants | 27 Participants | 14 Participants |
| History of Nulliparous (no SVD or CD) | 33 Participants | 60 Participants | 27 Participants |
| History of Surgical Abortion | 15 Participants | 33 Participants | 18 Participants |
| History of Vaginal Delivery | 19 Participants | 43 Participants | 24 Participants |
| Pain with Menses Visual Analog Scale | 56 units on a scale | 51 units on a scale | 42 units on a scale |
| Race/Ethnicity, Customized Hispanic | 20 Participants | 38 Participants | 18 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 9 Participants | 18 Participants | 9 Participants |
| Race/Ethnicity, Customized Non-Hispanic Other | 7 Participants | 12 Participants | 5 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 21 Participants | 43 Participants | 22 Participants |
| Race/Ethnicity, Customized Prefer not to answer | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 57 Participants | 112 Participants | 55 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 73 |
| other Total, other adverse events | 0 / 71 | 0 / 73 |
| serious Total, serious adverse events | 0 / 71 | 0 / 73 |
Outcome results
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.
Time frame: 15 minutes post-procedure
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend | Patient Satisfaction With Anesthesia | 0.72 score on a scale | Standard Deviation 0.96 |
| Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis) | Patient Satisfaction With Anesthesia | 0.46 score on a scale | Standard Deviation 0.98 |
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.
Time frame: 11 months
Population: During analysis, participants who neither agreed or disagreed were considered not satisfied.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend | Acceptability | Agreed inhaling scented was helpful during procedure. | 25 Participants |
| Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend | Acceptability | Would recommend inhaling scented oil to a friend who needed a procedural abortion. | 31 Participants |
| Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend | Acceptability | If needed another procedural abortion, would want to inhale scented oil during procedure | 39 Participants |
| Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis) | Acceptability | Agreed inhaling scented was helpful during procedure. | 41 Participants |
| Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis) | Acceptability | Would recommend inhaling scented oil to a friend who needed a procedural abortion. | 49 Participants |
| Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis) | Acceptability | If needed another procedural abortion, would want to inhale scented oil during procedure | 50 Participants |
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).
Time frame: Immediately post-procedure
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend | Maximum Procedural Pain | 63 millimeters |
| Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis) | Maximum Procedural Pain | 65 millimeters |
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.
Time frame: 15 minutes post-procedure
Population: During analysis, participants who neither agreed or disagreed were considered not satisfied.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend | Patient Acceptability of Lavender Aromatherapy in Procedural Abortion | Agreed inhaling scented was helpful during procedure. | 25 Participants |
| Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend | Patient Acceptability of Lavender Aromatherapy in Procedural Abortion | Would recommend inhaling scented oil to a friend who needed a procedural abortion. | 31 Participants |
| Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend | Patient Acceptability of Lavender Aromatherapy in Procedural Abortion | If needed another procedural abortion, would want to inhale scented oil during procedure | 39 Participants |
| Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis) | Patient Acceptability of Lavender Aromatherapy in Procedural Abortion | Agreed inhaling scented was helpful during procedure. | 41 Participants |
| Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis) | Patient Acceptability of Lavender Aromatherapy in Procedural Abortion | Would recommend inhaling scented oil to a friend who needed a procedural abortion. | 49 Participants |
| Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis) | Patient Acceptability of Lavender Aromatherapy in Procedural Abortion | If needed another procedural abortion, would want to inhale scented oil during procedure | 50 Participants |