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Trial registered on ANZCTR


Registration number
ACTRN12614000130662
Ethics application status
Not yet submitted
Date submitted
29/01/2014
Date registered
4/02/2014
Date last updated
4/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Essential Oils for Agitation Management in Older Adults: A Mixed Method Study
Scientific title
In older adults living in residential aged care facilities with unresolved agitation, can essential oils when compared to placebo reduce their agitation?
Secondary ID [1] 283999 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Agitation prevention 291017 0
Dementia 291061 0
Condition category
Condition code
Alternative and Complementary Medicine 291360 291360 0 0
Other alternative and complementary medicine
Neurological 291403 291403 0 0
Dementias
Mental Health 291404 291404 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a two by three factorial design. The first factor is the degree to which participants have dementia and consists of 2 groups dementia or no dementia. The second factor is the essential oil treatment and consists of 3 groups: Lavendula Angustifolia, Melissa Officinallis and placebo Sunflower oil. The second factor is within group factor, as all participants will receive all three treatments separately during the study with a two week washout period between each treatment were velcro will be attached daily without essential oil or placebo. Velcro will remain in place for a minimum of 2 hours during treatment and washout before being removed.

Lavendula Angustifolia essential oil- 2 drops applied to 2.5x2cm cotton wadding attached to participants lapel with double sided Velcro daily for 2 weeks.

Melissa Officinalis essential oil - 2 drops applied to 2.5x2cm cotton wadding attached to participants lapel with double sided Velcro daily for 2 weeks.
Intervention code [1] 288673 0
Treatment: Other
Intervention code [2] 288713 0
Prevention
Comparator / control treatment
Sunflower oil (unscented) - 2 drops applied to 2.5x2cm cotton wadding attached to participants lapel with double sided Velcro daily for 2 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 291356 0
Participant agitation levels will be observed, recorded and monitored throughout this study, in conjunction with a nurse carer, using the Neuropyschiatric Inventory (NPI) and Cohen-Mansfield Agitation Inventory(CMAI).

The NPI and CMAI are validated and reliable measurement tools for agitation in this population.
Timepoint [1] 291356 0
NPI and CMAI data will be collected every two weeks coinciding with the conclusion of interventions and placebo treatments. NPI and CMAI data will also be collected at baseline and after every two week washout between treatment to give a new baseline.
Secondary outcome [1] 306583 0
Participant Quality of Life [QoL] will be measured throughout this study by have the participant complete the LEIPAD questionnaire. The LEIPAD survey measures psychosocial functions of cognitive functioning, depression/anxiety and life satisfaction.
Timepoint [1] 306583 0
LEIPAD data will be collected every two weeks coinciding with the conclusion of interventions and placebo treatments. LEIPAD data will also be collected at baseline and after every two week washout between treatment to give a new baseline.
Secondary outcome [2] 306584 0
Agitation levels and QoL measures will be compared respective and irrespective of treatment between the older adult participant groups of dementia and no dementia participants.
Timepoint [2] 306584 0
Data from the NPI, CMAI and LEIPAD QoL will be compared at the studies conclusion when all participant data has been collected.
Secondary outcome [3] 306585 0
Semi-structured nurse interviews will explore nurse perceptions towards agitation, relationship to dementia, complementary therapies and their applications as a management for agitation in residential aged care facilities.
Timepoint [3] 306585 0
Nurse interviews will be conducted prior to the randomised controlled trial [RCT] commencing and again after the RCT has concluded. Nurse participants will be consenting regular carers of older adult participants who inform the NPI and CMAI from observation.

Eligibility
Key inclusion criteria
Older adult participant inclusion criteria
*Participants are aged 65 years or older.
*Participants must be living full time in a residential aged care facility (RACF) and have been a resident for 3 months to ensure they are familiar with the RACF processes and settled into their environment.
*A cognitive level of moderate or higher as demonstrated by a score above 10 on the mini mental state examination [MMSE] (American Psychiatric Association 1991).
*Recorded agitated behaviours on at least one of the Aged Care Funding Instrument [ACFI] behaviours domain questions. Behaviour question being question 7 wandering, question 8 verbal behaviours and question 9 physical agitations.
*Be stable upon medication for 3 months as confirmed by medication charts. Any changes in psychotropic medications needs to be reported to investigator.
*At least one, agitated behaviour with a frequency of at least 6 occurrences observed by the nurse in the last two weeks assessed on the NPI at baseline.
*Have no allergy to Lavender, Lemon Balm or Sunflower oil to be assessed at baseline.
*Ability to detect scent as demonstrated in a scent test at baseline.
*The participant or the person responsible, have given consent.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Older adult participant exclusion criteria
*Diagnosis of psychosis or agitation resulting from brain damage.
*The presence of an acute life-threatening condition as reported by staff or the local medical officer.
*Any condition that is likely to confound the study such as schizophrenia or Parkinson disease or another medical condition as determined by investigator to interfere with interpretation of study results.

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)
Randomisation and intervention sequencing will be preformed by an independent researcher. Participants will initially be allocated to dementia (30 participants) or no dementia (30 participant) group as determined by Mini Mental State Examination (MMSE) score. Participants will then allocated a sequence of the three treatments in this study using block randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants will be randomly allocated a treatment sequence A, B or C giving a total of six groups for comparison. Participants, researchers and staff will be unaware of group allocation and treatment sequence. A factorial design allows comparison within participants for intervention effect and also examination between the independent groups, dementia and no dementia.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288625 0
University
Name [1] 288625 0
School of Nursing and Midwifery, University of Western Sydney
Country [1] 288625 0
Australia
Primary sponsor type
University
Name
School of Nursing and Midwifery, University of Western Sydney
Address
Locked Bag 1797
Penrith NSW 2751
Australia
Country
Australia
Secondary sponsor category [1] 287332 0
None
Name [1] 287332 0
Address [1] 287332 0
Country [1] 287332 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290483 0
Human Research Ethics Committee
Ethics committee address [1] 290483 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Ethics committee country [1] 290483 0
Australia
Date submitted for ethics approval [1] 290483 0
07/02/2014
Approval date [1] 290483 0
Ethics approval number [1] 290483 0

Summary
Brief summary
This study is the first three-phase mixed method sequential design conducted to investigate the effect of Lavender or Lemon Balm on agitation in older people living in residential aged care facilities [RACFs]. This study will investigate the clinical effect of the essential oils on agitation and the situation, RACF setting, in which the clinical investigation is being conducted to identify perceptions or bias which may influence the study and outcomes. This proposed study is guided by the following questions:
*What is the effect of Lavender or Lemon Balm aromatherapy on agitation in older people living in RACFs?
*Are there differences between the agitation behaviour, frequency or severity experienced relative to no dementia or the degree of dementia?
*Is the effectiveness of agitation management with Lavender or Lemon Balm dependent on no dementia or degree of dementia?
*Can aromatherapy management affect the quality of life for the older person living in RACFs?
*Can a nurse’s pre conceived perception and clinical experiences of aromatherapy effect methods and outcomes in essential oil investigations?
This research seeks to answer the research questions by addressing five hypotheses:
*Participants when receiving the Lavender or Lemon Balm aromatherapy treatment will experience less agitation than when receiving placebo treatment.
*Participants who have dementia will experience greater agitation than participants who have no dementia.
*Aromatherapy affects agitation differently in older people with no dementia to those with dementia.
*Participant’s quality of life will improve with aromatherapy treatment groups than those receiving the placebo.
*Bias in the study will be identified through nurses’ perceptions of aromatherapies effectiveness and practicality in RACFs
Trial website
Trial related presentations / publications
Watson, K., Chang, E., Johnson, A. (2012). The efficacy of complementary therapies for agitation among older people in residential aged care: A systematic review. JBI Library of Systematic Reviews, 10(53): 3414-3486 http://connect.jbiconnectplus.org/JBIReviewsLibrary.aspx
Public notes

Contacts
Principal investigator
Name 45866 0
Ms Karen Watson BHlthSc (Naturopathy); BNGE; BN(Hons) PhD Candidate
Address 45866 0
School of Nursing and Midwifery
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Australia
Country 45866 0
Australia
Phone 45866 0
+61 2 9852 5222
Fax 45866 0
Email 45866 0
[email protected]
Contact person for public queries
Name 45867 0
Karen Watson BHlthSc (Naturopathy); BNGE; BN(Hons) PhD Candidate
Address 45867 0
School of Nursing and Midwifery
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Australia
Country 45867 0
Australia
Phone 45867 0
+61 2 9852 5222
Fax 45867 0
Email 45867 0
[email protected]
Contact person for scientific queries
Name 45868 0
Karen Watson BHlthSc (Naturopathy); BNGE; BN(Hons) PhD Candidate
Address 45868 0
School of Nursing and Midwifery
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Australia
Country 45868 0
Australia
Phone 45868 0
+61 2 9852 5222
Fax 45868 0
Email 45868 0
[email protected]

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Results publications and other study-related documents

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