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

ISRCTN	ISRCTN75633164
DOI	https://doi.org/10.1186/ISRCTN75633164
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr George Lewith
Scientific

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Phone	+44 (0)2380 241073
Email	gl3@soton.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Insomnia
Intervention	Aromatherapy oils - lavender oil versus geranium oil versus almond oil (placebo)
Intervention type	Other
Primary outcome measure	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 study start date	01/12/2005
Completion date	30/04/2006

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	12
Key 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
Key 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
Date of first enrolment	01/12/2005
Date of final enrolment	30/04/2006

Aldermoor Health Centre

Southampton
SO16 5ST
United Kingdom

University of the West of England (UK)
University/education

Coldharbour Lane
Bristol
BS16 1QY
England
United Kingdom

Email	c.alford@uwe.ac.uk
"ROR"	https://ror.org/02nwg5t34

University/education

University of Southampton Fourth Year Medical Student Project

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

18/10/2016: No publications found.