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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04969900
• Other study ID #: 21-2561
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: April 19, 2022

Study information

• Verified date: August 2021
• Source: University of Colorado, Denver
• Contact: Leanne Free, MD
• Phone: 720-810-5442
• Email: LEANNE.FREE[@]CUANSCHUTZ.EDU
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: April 19, 2022
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Pain
• Patient Satisfaction
• Surgical Abortion

Intervention

Other:
• Placebo oil
The placebo group will receive placebo oil.
• Lavender oil.
Investigational Product. This group will receive Lavender oil.

Locations

Country	Name	City	State
United States	Comprehensive Women's Health Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 year
Secondary	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
Secondary	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
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 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
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.	1 year

External Links

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