Trial Outcomes & Findings for Effects of Aromatherapy on Patient Satisfaction With Surgical Abortion at Less Than 10 Weeks Gestation (NCT NCT04969900)
NCT ID: NCT04969900
Last Updated: 2025-08-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
144 participants
Primary outcome timeframe
15 minutes post-procedure
Results posted on
2025-08-03
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
73
|
|
Overall Study
COMPLETED
|
55
|
57
|
|
Overall Study
NOT COMPLETED
|
16
|
16
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
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
There were 3 non-responders in the aromatherapy group and 1 in the placebo group
Baseline characteristics by cohort
| Measure |
Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend
n=57 Participants
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.
|
Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis)
n=55 Participants
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.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27 years
n=5 Participants
|
28 years
n=7 Participants
|
27 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Other
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Prefer not to answer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
History of
Vaginal Delivery
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
History of
Cesarean Delivery
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
History of
Miscarriage
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
History of
Medication Abortion
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
History of
Surgical Abortion
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
History of
Nulliparous (no SVD or CD)
|
33 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Highest Level of Education
Graduated college or graduate school
|
24 Participants
n=5 Participants • There were 3 non-responders in the aromatherapy group and 1 in the placebo group
|
22 Participants
n=7 Participants • There were 3 non-responders in the aromatherapy group and 1 in the placebo group
|
46 Participants
n=5 Participants • There were 3 non-responders in the aromatherapy group and 1 in the placebo group
|
|
Highest Level of Education
Less than college (some college, graduated high school, GED, vocational school)
|
30 Participants
n=5 Participants • There were 3 non-responders in the aromatherapy group and 1 in the placebo group
|
32 Participants
n=7 Participants • There were 3 non-responders in the aromatherapy group and 1 in the placebo group
|
62 Participants
n=5 Participants • There were 3 non-responders in the aromatherapy group and 1 in the placebo group
|
|
Highest Level of Education
Non-responders
|
3 Participants
n=5 Participants • There were 3 non-responders in the aromatherapy group and 1 in the placebo group
|
1 Participants
n=7 Participants • There were 3 non-responders in the aromatherapy group and 1 in the placebo group
|
4 Participants
n=5 Participants • There were 3 non-responders in the aromatherapy group and 1 in the placebo group
|
|
Pain with Menses Visual Analog Scale
|
56 units on a scale
n=5 Participants
|
42 units on a scale
n=7 Participants
|
51 units on a scale
n=5 Participants
|
|
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
n=5 Participants
|
45 units on a scale
n=7 Participants
|
45 units on a scale
n=5 Participants
|
|
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
n=5 Participants
|
37 units on a scale
n=7 Participants
|
36 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutes post-procedurePopulation: 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).
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.
Outcome measures
| Measure |
Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend
n=57 Participants
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.
|
Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis)
n=55 Participants
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.
|
|---|---|---|
|
Patient Satisfaction With Anesthesia
|
0.72 score on a scale
Standard Deviation 0.96
|
0.46 score on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Immediately post-procedurePopulation: 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).
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).
Outcome measures
| Measure |
Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend
n=55 Participants
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.
|
Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis)
n=57 Participants
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.
|
|---|---|---|
|
Maximum Procedural Pain
|
63 millimeters
Interval 7.0 to 97.0
|
65 millimeters
Interval 4.0 to 95.0
|
SECONDARY outcome
Timeframe: 11 monthsPopulation: During analysis, participants who "neither agreed or disagreed" were considered not satisfied.
Patient acceptability of lavender aromatherapy as a complementary and alternative medicine used during first trimester surgical abortion as measured through a post-procedure survey.
Outcome measures
| Measure |
Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend
n=55 Participants
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.
|
Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis)
n=57 Participants
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.
|
|---|---|---|
|
Acceptability
Would recommend inhaling scented oil to a friend who needed a procedural abortion.
|
31 Participants
|
49 Participants
|
|
Acceptability
Agreed inhaling scented was helpful during procedure.
|
25 Participants
|
41 Participants
|
|
Acceptability
If needed another procedural abortion, would want to inhale scented oil during procedure
|
39 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 15 minutes post-procedurePopulation: During analysis, participants who "neither agreed or disagreed" were considered not satisfied.
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.
Outcome measures
| Measure |
Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend
n=55 Participants
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.
|
Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis)
n=57 Participants
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.
|
|---|---|---|
|
Patient Acceptability of Lavender Aromatherapy in Procedural Abortion
Agreed inhaling scented was helpful during procedure.
|
25 Participants
|
41 Participants
|
|
Patient Acceptability of Lavender Aromatherapy in Procedural Abortion
Would recommend inhaling scented oil to a friend who needed a procedural abortion.
|
31 Participants
|
49 Participants
|
|
Patient Acceptability of Lavender Aromatherapy in Procedural Abortion
If needed another procedural abortion, would want to inhale scented oil during procedure
|
39 Participants
|
50 Participants
|
Adverse Events
Placebo - Jojoba Oil (100% Organic Golden Expeller-pressed Simmondsia Chinensis)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Investigational Product - A 10% Dilute Lavandula Angustifolia - Jojoba Oil Essential Oil Blend
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place