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Trial record 30 of 73 for:    aromatherapy

Aromatherapy to Reduce Pain and Anxiety During Cervical Colposcopy (Lavender Colpo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01214304
Recruitment Status : Completed
First Posted : October 5, 2010
Last Update Posted : November 25, 2013
Sponsor:
Collaborator:
American Academy of Family Physicians
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colposcopy Other: Essential Lavender Oil Other: Lavender Scent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Aromatherapy With Lavender Oil to Reduce Pain and Anxiety During Cervical Colposcopy: A Randomized, Controlled Trial
Study Start Date : February 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Placebo Comparator: 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.
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.

Experimental: 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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Anxiety Level [ Time Frame: 8 months ]
    Patients will be measured on an 11 point scale from 0 to 10 on their anxiety level.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214304


Locations
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United States, Nevada
Mike O'Callaghan Federal Medical Center
Las Vegas, Nevada, United States, 89191
Sponsors and Collaborators
Mike O'Callaghan Military Hospital
American Academy of Family Physicians
Investigators
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Principal Investigator: Paul Crawford, M.D. Mike O'Callaghan Federal Medical Center

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Responsible Party: Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT01214304     History of Changes
Other Study ID Numbers: FWH20100154H
First Posted: October 5, 2010    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Mike O'Callaghan Military Hospital:
Colposcopy