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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01214304
Other study ID # FWH20100154H
Secondary ID
Status Completed
Phase N/A
First received September 30, 2010
Last updated November 21, 2013
Start date February 2011
Est. completion date November 2013

Study information

Verified date November 2013
Source Mike O'Callaghan Federal Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether aromatherapy with lavender oil compared to placebo lowers anxiety levels in women during colposcopy.


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.


Recruitment information / eligibility

Status Completed
Enrollment 262
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Essential Lavender Oil
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.
Lavender Scent
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.

Locations

Country Name City State
United States Mike O'Callaghan Federal Medical Center Las Vegas Nevada

Sponsors (2)

Lead Sponsor Collaborator
Mike O'Callaghan Federal Hospital American Academy of Family Physicians

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Level Patients will be measured on an 11 point scale from 0 to 10 on their pain Level. 8 months No
Secondary Anxiety Level Patients will be measured on an 11 point scale from 0 to 10 on their anxiety level. 8 months No
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