Aromatherapy to Reduce Pain and Anxiety During Cervical Colposcopy

Not Applicable

Completed

• Conditions: Colposcopy
• Interventions: Other: Lavender Scent; Other: Essential Lavender Oil

• Registration Number: NCT01214304
• Lead Sponsor: Mike O'Callaghan Military Hospital

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.

Study Timeline

• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-05
• Study Start: 2011-02
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 262

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lavender Scent	Lavender Scent	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.
Essential Lavender Oil	Essential Lavender Oil	Patients will receive essential Lavender Oil which will be initiated 5 minutes prior to the procedure and continued until the conclusion of the procedure.

Primary Outcome Measures

Name	Time	Method
Pain Level	8 months	Patients will be measured on an 11 point scale from 0 to 10 on their pain Level.

Secondary Outcome Measures

Name	Time	Method
Anxiety Level	8 months	Patients will be measured on an 11 point scale from 0 to 10 on their anxiety level.

Trial Locations

Locations (1)

Mike O'Callaghan Federal Medical Center; 🇺🇸 Las Vegas, Nevada, United States