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Aromatherapy to Reduce Pain and Anxiety During Cervical Colposcopy

NCT ID: NCT01214304

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Colposcopy

Keywords

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Colposcopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Lavender Scent

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Essential Lavender Oil

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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American Academy of Family Physicians

OTHER

Sponsor Role collaborator

Mike O'Callaghan Military Hospital

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Crawford, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mike O'Callaghan Federal Medical Center

Locations

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Mike O'Callaghan Federal Medical Center

Las Vegas, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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FWH20100154H

Identifier Type: -

Identifier Source: org_study_id