Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000251628
Ethics application status
Approved
Date submitted
24/08/2005
Date registered
1/09/2005
Date last updated
21/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The acute effects of sandalwood oil and Massage on physiological and psychological parameters
Scientific title
The acute effects of sandalwood oil and Massage on physiological and psychological parameters
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physiological and psychological parameters 338 0
Condition category
Condition code
Other 390 390 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Other 391 391 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project was a randomised non-blinded study using a two-step factorial design. The two factors are essential oil and massage. Four conditions were investigated in total in each participant: In all cases 10mL of oil composed of 2.5mL active oil and 7.5mL Almond oil were rubbed onto the participants back over a five minute period. Participants then lay supine or were massaged for 30 minutes. Waking state was maintained over the duration of the treatment. Active oils were Sandalwood oil applied with no massage, Tea tree oil applied with no massage, Sandalwood oil with massage, and Tea tree oil with massage.
Intervention code [1] 244 0
Treatment: Other
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 447 0
Physiological (blood pressure, heart rate, skin temperature, oxygen saturation and galvanic skin response)
Timepoint [1] 447 0
Pre and post each treatment session
Primary outcome [2] 448 0
Psychological measurements (a self assessment of well being and perceived changes using 11 parameters, 6 negative and 5 positive)
Timepoint [2] 448 0
Pre and post each treatment session
Secondary outcome [1] 980 0
Psychological outcome measurements comprised a self-assessment of well being using 11 parameters, 6 negative and 5 positive.
Timepoint [1] 980 0
Measured weekly pre and post each treatment point.

Eligibility
Key inclusion criteria
Provision of informed consent. Have normal general health. Agree to stop topical applications on the days of the study. Agree to comply with the study protocol.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with acute or chronic musculo-skeletal conditions, which would be adversely affected by massage. Persons with skin lesions on their back. Individuals taking oral medications such as anti-hypertensives or benzodiazepines. Individuals with conditions considered by the investigators to influence the natural history of stress. All persons with a past sensitivity to topical preparations, especially Sandalwood Oil and Tea-Tree Oil. Female subjects who were pregnant or lactating.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The treatment groups were numbered 1-4 and 4 copies made of each number. Participants names were placed in one container and the numbers in a second container, one slip was drawn from each container until all the treatments were assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Four conditions were investigated in total in each participant: sandalwood oil applied with no massage, tea tree oil applied with no massage, sandalwood oil with massage, and tea tree oil with massage. The treatment groups were numbered 1-4 and 4 copies made of each number. Participants names were placed in one container and the numbers in a second container, one slip was drawn from each container until all the treatments were assigned.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/11/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 442 0
Commercial sector/Industry
Name [1] 442 0
Mount Romance
Country [1] 442 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
MOunt Romance
Address
Country
Australia
Secondary sponsor category [1] 360 0
None
Name [1] 360 0
none
Address [1] 360 0
Country [1] 360 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1415 0
Southern Cross university Human Research Ethics Committee
Ethics committee address [1] 1415 0
Ethics committee country [1] 1415 0
Australia
Date submitted for ethics approval [1] 1415 0
Approval date [1] 1415 0
Ethics approval number [1] 1415 0

Summary
Brief summary
A randomised non-blinded study was conducted over 4 weeks using a two-step factorial design aimed at obtaining pilot data on the acute effect of essential oils alone and in combination with a back massage on a range of physiological and psychological parameters.

The two factors were essential oil and massage. Four conditions were investigated in each participant: sandalwood oil applied with no massage, tea tree oil applied with no massage, sandalwood oil with massage, and tea tree oil with massage. In all cases 10mL of oil composed of 2.5mL active oil and 7.5mL almond oil were rubbed onto the participantÿ¢ÿ¿ÿ¿s back over a five-minute period. Participants then lay supine or were massaged for 30 minutes after the application of the oil. Waking state was maintained over the duration of the treatment.

A convenience sample of 15 healthy subject volunteers between 18 and 65 years was recruited and each subject acted as their own control and was tested on all four conditions. Physiological and psychological outcome measurements were taken pre and post each treatment session. Physiological measurements included change in blood pressure, heart rate, skin temperature, oxygen saturation and galvanic skin response. Psychological outcome measurements comprised a self-assessment of well being using 11 parameters, 6 negative and 5 positive.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35289 0
Address 35289 0
Country 35289 0
Phone 35289 0
Fax 35289 0
Email 35289 0
Contact person for public queries
Name 9433 0
Professor Stephen Myers
Address 9433 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 9433 0
Australia
Phone 9433 0
+61 2 66203403
Fax 9433 0
+61 2 66203307
Email 9433 0
smyers@scu.edu.au
Contact person for scientific queries
Name 361 0
Joan O'Connor
Address 361 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 361 0
Australia
Phone 361 0
+61 2 66203649
Fax 361 0
+61 2 66203307
Email 361 0
joconnor@scu.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.