ColposcopyLavender ColpoNCT01214304
Aromatherapy to Reduce Pain and Anxiety During Cervical Colposcopy
A study testing Essential Lavender Oil and Lavender Scent in people with Colposcopy, run by Mike O'Callaghan Military Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine whether aromatherapy with lavender oil compared to placebo lowers anxiety levels in women during colposcopy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Colposcopy
- What is being tested?
- Essential Lavender Oil and Lavender Scent
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Federal Medical Center
Las Vegas, Nevada, 89191
About this study
Official title: Aromatherapy With Lavender Oil to Reduce Pain and Anxiety During Cervical Colposcopy: A Randomized, Controlled Trial
The purpose of this study is to determine whether aromatherapy with lavender oil compared to placebo lowers anxiety levels in women during colposcopy.
Read the 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.
- Conditions
- Colposcopy
- Being tested
- Essential Lavender Oil, Lavender Scent
- Keywords
- Colposcopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential Lavender OilOther
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 ScentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lavender Scent | Placebo comparator | 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. Receives: Other: Lavender Scent |
| Essential Lavender Oil | Experimental | Patients will receive essential Lavender Oil which will be initiated 5 minutes prior to the procedure and continued until the conclusion of the procedure. Receives: Other: Essential Lavender Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
Patients will be measured on an 11 point scale from 0 to 10 on their pain Level.
Measured: 8 months
Secondary outcomes (1)
Anxiety Level
Patients will be measured on an 11 point scale from 0 to 10 on their anxiety level.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startFeb 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColposcopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Collaborators
- American Academy of Family Physicians
- Responsible party
- Sponsor
- Investigators
- Paul Crawford, M.D., Principal investigator, Mike O'Callaghan Federal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214304
- Sponsor's protocol ID
- FWH20100154H
- Acronym
- Lavender Colpo
- Status last verified
- Nov 2013
- First submitted
- 30 Sep 2010
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy With Lavender Oil to Reduce Pain and Anxiety During Cervical Colposcopy: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01214304
- Acronym / sponsor ID
- Lavender Colpo / FWH20100154H
- Conditions
- Colposcopy
- Keywords
- Colposcopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Collaborators
- American Academy of Family Physicians
- Study start
- Feb 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lavender Scent | Placebo comparator | Other: Lavender ScentPatients 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 | Experimental | Other: Essential Lavender OilPatients will receive essential Lavender Oil which will be initiated 5 minutes prior to the procedure and continued until the conclusion of the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- age <18 years
- pregnancy
- breastfeeding
- asthma
- poor sense of smell
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essential Lavender OilAromatherapy 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. | Other | Essential Lavender Oil |
| Lavender ScentAromatherapy 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. | Other | Lavender Scent |
Primary outcome
Pain Level
Time frame: 8 months
Patients will be measured on an 11 point scale from 0 to 10 on their pain Level.
1 secondary outcome
Anxiety Level
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Crawford, M.D. principal investigator
Mike O'Callaghan Federal Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential Lavender Oil and Lavender Scent in people with Colposcopy, run by Mike O'Callaghan Military Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.