Evaluation of an aromatherapy service on a leukaemia unit

ISRCTN	ISRCTN16626262
DOI	https://doi.org/10.1186/ISRCTN16626262
Secondary identifying numbers	N0063054436

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 24/05/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr J Stringer
Scientific

Adult Leukaemia Unit
Christie Hospial NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study hypothesis	1. To evaluate the aromatherapy/massage service offered to patients on the Adult Leukaemia Unit (ALU) of the Christie Hospital NHS Trust 2. To assess whether massage with essential oils is more effective than massage with base oil or time for peace and calm at reducing physiological and psychological symptoms of stress and perception of pain
Ethics approval(s)	Not provided at time of registration
Condition	Cancer: Leukaemia
Intervention	1. Arm A: No massage 2. Arm B: Massage with essential oil 3. Arm C: Massage without essential oil Those randomised to either of the two experimental arms will receive a part body massage once a week for the duration of their stay as an in-patient on the ALU (with or without essential oils depending on which arm they are in). Those in the control arm will rest on their beds for an equivalent length of time. All study participants will rest on their beds for twenty minutes prior to treatment after which blood samples will be taken for hormone levels. Once this has been done patients will be asked to fill in the quality of life questionnaire. Following completion, those patients in the experimental groups will receive their massage. Following the therapy session the patients will be allowed to rest for 10 minutes then more blood samples will be taken for hormone levels. This sampling will be repeated half hourly for two hours. At this final session a semi-structured interview will be conducted to aid evaluation of the effect the therapist may have on the patient. The patient will also be asked to fill in pain and quality of life measures at this point. The questionnaires and blood sampling will be repeated after 24 hours.
Intervention type	Other
Primary outcome measure	Reducing cortisol and prolactin levels
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/2001
Overall study end date	15/08/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	189 NHS patients maximum
Participant inclusion criteria	Not provided at time of registration
Participant exclusion criteria	Not provided at time of registration
Recruitment start date	01/05/2001
Recruitment end date	15/08/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Adult Leukaemia Unit

Manchester
M20 4BX
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Christie Hospital NHS Trust (UK)

No information available

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2008		Yes	No