Aromatherapy to Reduce Pain and Anxiety During Cervical Colposcopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether aromatherapy with lavender oil compared to placebo lowers anxiety levels in women during colposcopy.

Detailed Description
-----------------
Aromatherapy is a modality that might reduce anxiety. Women experience high levels of anxiety and negative emotional responses at all stages of cervical cancer screening. High levels of anxiety before and during colposcopy can be bad. If lavender oil aromatherapy reduces anxiety, then simple use of this modality may improve experiences during colposcopy.

Official Title
-----------------
Aromatherapy With Lavender Oil to Reduce Pain and Anxiety During Cervical Colposcopy: A Randomized, Controlled Trial

Conditions
-----------------
Colposcopy

Intervention / Treatment
-----------------
* Other: Essential Lavender Oil
* Other: Lavender Scent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB All women at least 18 yrs of age undergoing colposcopy who have not previously participated in this protocol. Exclusion Criteria: age <18 years pregnancy breastfeeding asthma poor sense of smell allergy to one of the essential oils consumption of any analgesic short-term anxiolytic (i.e. benzodiazepines) or chronic anxiolytic medications (i.e. SSRI)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Lavender Scent<br>Patients will receive aromatherapy with a fake lavender scent (placebo) which will be initiated 5 minutes prior to the procedure and continued until the conclusion of the procedure. | Other: Lavender Scent<br>* Aromatherapy with a fake lavender scent (placebo) will be initiated 5 minutes prior to the procedure and continued until the conclusion of the procedure (patient dressed and ready to leave the room). The fake lavender scent will be administered by fan diffuser.<br>|
| Experimental: Essential Lavender Oil<br>Patients will receive essential Lavender Oil which will be initiated 5 minutes prior to the procedure and continued until the conclusion of the procedure. | Other: Essential Lavender Oil<br>* Aromatherapy with essential lavender oil will be initiated 5 minutes prior to the procedure and continued until the conclusion of the procedure (patient dressed and ready to leave the room). The essential lavender oil and will be administered by fan diffuser.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Level | Patients will be measured on an 11 point scale from 0 to 10 on their pain Level. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Level | Patients will be measured on an 11 point scale from 0 to 10 on their anxiety level. | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colposcopy