Comparison the effect of multi-sensory stimulation intervention and aromatherapy inhalation with lavender essential oil on anxiety, depression and well-being in the elderly undergoing hemodialysis
Comparison the effect of multi-sensory stimulation intervention and aromatherapy inhalation with lavender essential oil on anxiety, depression and well-being in the elderly undergoing hemodialysis
Design
A concealed, randomized, clinical trial with a parallel group design of 44 patients, in 2019-2020, and followed for one month
Settings and conduct
The study will be performed in the hemodialysis ward of the Sari dialysis center during hemodialysis on the elderly under hemodialysis referred to the dialysis center.
Participants/Inclusion and exclusion criteria
1) Chronological age 60 and older 2) Alertness and ability to communicate 3) Normal cognitive status based on abbreviated mental test (AMT) 4) Mild to moderate anxiety 5) Mild to moderate depression 6) Having a hemodialysis history at least 6 months and at least 3 hemodialysis sessions per week 7) Having sensory health of hearing, sight and smell 8) No allergies to lavender odor 9) No alcohol use and no opioid or 10) No experience of any event that may cause increasing mental pressure on a person 6 months ago 11) No participation in the anxiety and depression classes concurrently or not being consulted with a psychologist or psychiatrist 12) No psychotropic drugs use
Intervention groups
Multi-sensory stimulation (olfactory, visual and auditory stimulation) will be administered three days a week (even days) for four weeks, each session will be 25 minutes. Auditory stimulation will be performed by using relaxed and wordless music playback by Dan Gibson, visual stimulation using nature images, and olfactory stimulation using aromatherapy with lavender essential oil. Patients in the other group (aromatherapy group) will receive only aromatherapy with lavender essential oil.
Main outcome variables
anxiety, depression and well-being
General information
Reason for update
Acronym
مقایسه ی تاثیر تحریکات چند حسی و رایحه درمانی با اسطوخودوس بر اضطراب، افسردگی و احساس خوب بودن سالمندان همودیالیزی
IRCT registration information
IRCT registration number:IRCT20170611034454N4
Registration date:2019-12-03, 1398/09/12
Registration timing:prospective
Last update:2019-12-03, 1398/09/12
Update count:0
Registration date
2019-12-03, 1398/09/12
Registrant information
Name
Ehteram Sadat Ilali
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
z.arab1388@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-21, 1398/09/30
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of multi-sensory stimulation intervention and aromatherapy inhalation with lavender essential oil on anxiety, depression and well-being in the elderly undergoing hemodialysis
Public title
Comparison the effect of multi-sensory stimulation intervention and aromatherapy with lavender essence on anxiety, depression and well-being in the elderly undergoing hemodialysis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Chronological age 60 and older
Alertness and ability to communicate (ability to answer questions)
Normal cognitive status based on abbreviated mental test (AMT) (score 7 and above)
Mild to moderate anxiety (score 16-10)
Mild to moderate depression (score 5-11)
Having a hemodialysis history at least 6 months and at least 3 hemodialysis sessions per week
Having sensory health of hearing, sight and smell
No allergies to lavender odor
No alcohol use and no opioid or
No experience of any event that may cause increasing mental pressure on a person (death of a spouse or other family member, divorce, serious illness and other adverse events) 6 months ago
No participation in the anxiety and depression classes concurrently or not being consulted with a psychologist or psychiatrist
No psychotropic drugs (sedatives/ hypnotics/ antidepressants/ anti-anxiety) use
Exclusion criteria:
Incidence of allergy to perfume during intervention
Candidate for Kidney Transplant
Having other Neuropsychiatric Disorders
Absence of more than three sessions at the time of intervention
Lack of interest to music
withdrawal or unwillingness to Continue to study
die
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
The method of random allocation of the samples to the two groups will be blocking. The blocking is done with random allocation software and 11 quadruple blocks are generated with the software then samples with inclusion criteria are assigned to each of the multi-sensory stimulation or aromatherapy groups accordingly. To hide the random allocation, 44 non-transparent envelopes (for the sake of clarity of envelope content) were prepared, and each random sequence generated was recorded on a card and the cards were inserted in the envelope respectively. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the envelope door is glued and placed in a box, respectively. At the time the participants begin to register, based on the order of entry of the eligible participants into the study, one of the envelopes, respectively, opened and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Siences (Vice chanchellor for research), Moallem Square
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2019-11-17, 1398/08/26
Ethics committee reference number
IR.MAZUMS.REC.1398.1151
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Organic anxiety disorder
2
Description of health condition studied
Depression
ICD-10 code
F32.9
ICD-10 code description
Depressive episode, unspecified
3
Description of health condition studied
Hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Dialysis (renal) NOS
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention, at the end of the second and fourth weeks after the intervention and one week after the intervention
Method of measurement
Geriatric Anxiety Inventory (GAI)
2
Description
Depression
Timepoint
Before the intervention, at the end of the second and fourth weeks after the intervention and one week after the intervention
Method of measurement
Geriatric Depression Scale (GDS)
3
Description
Well-being
Timepoint
Before the intervention, at the end of the second and fourth weeks after the intervention and one week after the intervention
Method of measurement
Well-being Index (WHO-5-P)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 2: Multi-sensory stimulation intervention will include three types of stimulation in the form of auditory, visual and olfactory stimulation that will be performed in the hemodialysis ward of Sari Dialysis Center during hemodialysis on elderly patients undergoing hemodialysis. Auditory stimulation will be performed using relaxing and unassuming music playing with the sound of nature from Dan Gibson's collection of relaxing music songs with the sound of nature (birds singing, water sounds). Visual stimulation will be done using nature images (video slide shows and audio playback via a laptop (15-inch Lenovo E-ideapad 330 and headphones). Auditory and visual stimulation will be performed simultaneously for 10 minutes, then the elderly will rest for 5 minutes, and for 10 minutes the olfactory stimulation (aromatherapy) will be performed so that patients in the multi-sensory stimulation group will inhale the lavender essential oil. The patients of the multi-sensory stimulation groups will inhalated lavender essential oil that is diluted with almond oil in a ratio of 1:20 (5% lavender essential oil), both produced by Barij Essence Pharmaceuticals and are ISO 9001 certified and ISO/IEC 17025 certified. Patients receive lavender inhalation three days a week, alternately on Saturdays, Mondays, and Wednesdays for 4 weeks. So that a cotton ball impregnated with 3 drops of lavender essential oil at a concentration of 5% (diluted with sweet almond oil at a ratio of 1:20) adheres to the patient's collar and is asked to sit for 10 minutes to breathe normally. People are also asked not to use any perfume or cologne or other fragrance before or during the intervention. Finally, in the multi-sensory stimulation group, the three-week multi-sensory stimulation intervention will be performed on a daily basis in the even days (Saturday, Monday, Wednesday) for four weeks. Each session will last a total of 25 minutes.
Category
Rehabilitation
2
Description
Intervention group 2: Patients in the aromatherapy group will inhale the almond oil diluted with sweet almond oil for a period of 10 minutes in a ratio of 1:20 (5% lavender essential oil) that are produced by Barij Essence Pharmaceutical Company, it has ISO 9001 quality certified and ISO/ IEC 17025 standard. Patients receive lavender inhalation three days a week, alternately on Saturdays, Mondays, and Wednesdays for 4 weeks in the same way as aromatherapy in the multi-sensory stimulation group and will not receive visual and auditory stimuli.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrvand Dialysis Center
Full name of responsible person
Azar Jafari-Koulaei
Street address
Shahrvand Dialysis Center, Keshavarz Boulevard
City
Sari
Province
Mazandaran
Postal code
4819753187
Phone
+98 11 3329 1897
Email
jafaria241@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Research Vice-President of Mazandaran University of Medical Sciences, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3304 4001
Fax
+98 11 3336 2569
Email
jafaria241@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ehteram Sadat Ilali
Position
Assistant Professor, Ph.D in Gerontology, Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Nasibe Nursing and Midwifery School, Vesal Street
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3329 4601
Email
paradis2082000@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ehteram Sadat Ilali
Position
Assistant Professor, Ph.D in Gerontology, Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Nasibe Nursing and Midwifery School, Vesal street
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7374
Email
paradis2082000@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Azar Jafari-Koulaei
Position
Master Student, Geriatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
Nasibe Nursing and Midwifery School, Vesal Street
City
Sari
Province
Mazandaran
Postal code
4819753178
Phone
+98 11 3329 4601
Email
jafaria241@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available