Clinical trial NCT04969900: Effects of Aromatherapy on Patient Satisfaction With Surgical Abortion at Less Than 10 Weeks Gestation
Official title: Effects of Aromatherapy on Patient Satisfaction With Surgical Abortion at Less Than 10 Weeks Gestation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Abortion
Patient Satisfaction
Anesthesia
Pain
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Satisfaction with Anesthesia
timeFrame: 1 year
Secondary outcomes:
measure: Satisfaction Based on Baseline Anxiety
timeFrame: 1 year
measure: Difference in Patient Satisfaction Based on Sedation
timeFrame: 1 year
measure: Maximum Procedural Pain
timeFrame: 1 year
measure: Acceptability
timeFrame: 1 year
Other outcomes:
Locations:
city: Denver
country: United States
facility: Comprehensive Women's Health Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Leanne Free, MD
role: PRINCIPAL_INVESTIGATOR
References: