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Completed

NCT Number: NCT01214304

Aromatherapy to Reduce Pain and Anxiety During Cervical Colposcopy

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

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Key information

Conditions

Colposcopy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mike O'Callaghan Federal Medical Center

Las Vegas, Nevada, 89191, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Essential Lavender Oil

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.

Lavender Scent

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.

Primary outcomes

  1. Pain Level

    Time frame: 8 months

    Patients will be measured on an 11 point scale from 0 to 10 on their pain Level.

Secondary outcomes

  1. Anxiety Level

    Time frame: 8 months

    Patients will be measured on an 11 point scale from 0 to 10 on their anxiety level.

Sponsors and collaborators

Lead sponsor

Mike O'Callaghan Military Hospital

Fed

Collaborators

  • American Academy of Family Physicians

Registry information

Official study title

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

Acronym: Lavender Colpo

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 5, 2010
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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