Condition category
Mental and Behavioural Disorders
Date applied
24/10/2005
Date assigned
16/11/2005
Last edited
18/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes

18/10/2016: No publications found.