Aromatherapy to Reduce Pain and Anxiety During Cervical Colposcopy

Colposcopy Clinical Trial

— Lavender Colpo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214304
• Other study ID #: FWH20100154H
• 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

• Colposcopy

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