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 |
| Protocol serial number | N/A |
| Sponsor | University of the West of England (UK) |
| Funder | University of Southampton Fourth Year Medical Student Project |
- Submission date
- 24/10/2005
- Registration date
- 16/11/2005
- Last edited
- 18/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Dr George Lewith
Scientific
Scientific
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| Phone | +44 (0)2380 241073 |
|---|---|
| gl3@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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(s) |
1. Actigraphic data obtained from wrist worn actigraphs |
| Key secondary outcome measure(s) |
1. Leeds Sleep Evaluation Questionnaire |
| Completion date | 30/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Aldermoor Health Centre
Southampton
SO16 5ST
United Kingdom
SO16 5ST
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/10/2016: No publications found.
