None listed
Conditions
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
Interventions
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
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.
Sponsors
School of Nursing and Midwifery, University of Western Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed