Aromatherapy to Reduce Pain and Anxiety During Cervical Colposcopy
Lavender Colpo
Aromatherapy With Lavender Oil to Reduce Pain and Anxiety During Cervical Colposcopy: A Randomized, Controlled Trial
1 other identifier
interventional
262
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2010
CompletedFirst Posted
Study publicly available on registry
October 5, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 25, 2013
November 1, 2013
2.8 years
September 30, 2010
November 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Level
Patients will be measured on an 11 point scale from 0 to 10 on their pain Level.
8 months
Secondary Outcomes (1)
Anxiety Level
8 months
Study Arms (2)
Lavender Scent
PLACEBO COMPARATORPatients 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
EXPERIMENTALPatients will receive essential Lavender Oil which will be initiated 5 minutes prior to the procedure and continued until the conclusion of the procedure.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mike O'Callaghan Federal Medical Center
Las Vegas, Nevada, 89191, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Crawford, M.D.
Mike O'Callaghan Federal Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2010
First Posted
October 5, 2010
Study Start
February 1, 2011
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 25, 2013
Record last verified: 2013-11