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ISRCTN
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ISRCTN75633164
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ClinicalTrials.gov identifier
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Public title
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A comparative evaluation of Lavender (Lavendula augustifolia) and Geranium (Perlargonium species e.g. P. odoratissiumum, P. extipulatum, P. x fragrans) aromatherapy oils in participants with mild to moderate insomnia
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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To examine the credibility and effect size of lavender oil and geranium as potential treatments for mild insomnia and almond oil as a placebo.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Insomnia
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Participants - inclusion criteria
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1. Healthy individuals
2. Aged 20-55 years
3. Informed consent
4. Mild to moderate persistent insomnia defined as a Pittsburgh Sleep Quality Index Score within the range 5-14 assessed over the preceding month, and with a minimum of 3 weeks duration
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Participants - exclusion criteria
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1. Anosmic
2. Menopausal women
3. Pregnancy (or planning to become pregnant during the trial period)
4. Children under 3 years
5. Acutely ill
6. Systemic illness affecting their sleep
7. Recently treated with aromatherapy
8. Suffering from any recognised sleep pathology other than insomnia
9. Taking long-term medication (except oral contraceptives) or any short-term medication which may affect their natural sleep patterns
10. Previous hypersensitivity or allergy to aromatherapy or related products
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Anticipated start date
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01/12/2005
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Anticipated end date
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30/04/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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12
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Interventions
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Aromatherapy oils - lavender oil versus geranium oil versus almond oil (placebo)
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Primary outcome measure(s)
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1. Actigraphic data obtained from wrist worn actigraphs
2. Subjective sleep status assessed with the PSQI
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Secondary outcome measure(s)
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1. Leeds Sleep Evaluation Questionnaire
2. Borkovec and Nau Questionnaire
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Sources of funding
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University of Southampton Fourth Year Medical Student Project
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Trial website
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Publications
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Contact name
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Dr
George
Lewith
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Address
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Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
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City/town
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Southampton
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Zip/Postcode
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SO16 5ST
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Country
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United Kingdom
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Tel
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+44 (0)2380 241073
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Fax
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+44 (0)2380 701125
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Email
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gl3@soton.ac.uk
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Sponsor
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University of the West of England (UK)
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Address
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Coldharbour Lane
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City/town
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Bristol
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Zip/Postcode
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BS16 1QY
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Country
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United Kingdom
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Email
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c.alford@uwe.ac.uk
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Date applied
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24/10/2005
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Last edited
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29/09/2006
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Date ISRCTN assigned
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16/11/2005
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