Contact information
Type
Scientific
Primary contact
Dr George Lewith
ORCID ID
Contact details
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)2380 241073
gl3@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
Study hypothesis
To examine the credibility and effect size of lavender oil and geranium as potential treatments for mild insomnia and almond oil as a placebo.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Insomnia
Intervention
Aromatherapy oils - lavender oil versus geranium oil versus almond oil (placebo)
Intervention type
Other
Phase
Drug names
Primary outcome measures
1. Actigraphic data obtained from wrist worn actigraphs
2. Subjective sleep status assessed with the PSQI
Secondary outcome measures
1. Leeds Sleep Evaluation Questionnaire
2. Borkovec and Nau Questionnaire
Overall trial start date
01/12/2005
Overall trial end date
30/04/2006
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12
Participant exclusion criteria
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
Recruitment start date
01/12/2005
Recruitment end date
30/04/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Aldermoor Health Centre
Southampton
SO16 5ST
United Kingdom
Sponsor information
Organisation
University of the West of England (UK)
Sponsor details
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom
-
c.alford@uwe.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Southampton Fourth Year Medical Student Project
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary