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IRCT20170611034454N4 IRCT 2019-12-03 Mazandaran University of Medical Sciences Comparison the effect of multi-sensory stimulation intervention and aromatherapy with lavender essence on anxiety, depression and well-being in the elderly undergoing hemodialysis مقایسه ی تاثیر تحریکات چند حسی و رایحه درمانی با اسطوخودوس بر اضطراب، افسردگی و احساس خوب بودن سالمندان همودیالیزی 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 2019-12-21 anticipated 44 Complete https://irct.ir/trial/43727 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, 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. N/A Condition 1: Anxiety. Condition 2: Depression. Condition 3: Hemodialysis. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Ehteram Sadat Ilali
Nasibe Nursing and Midwifery School, Vesal Street
Sari Iran (Islamic Republic of) 4816715793 +98 11 3329 4601 paradis2082000@yahoo.com Mazandaran University of Medical Sciences scientific Ehteram Sadat Ilali
Nasibe Nursing and Midwifery School, Vesal street
Sari Iran (Islamic Republic of) 4816715793 +98 11 3336 7374 paradis2082000@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 60 years no limit Both 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 F06.4 F32.9 Z49.1 Organic anxiety disorder Depressive episode, unspecified Dialysis (renal) NOS Rehabilitation Rehabilitation 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. 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. 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). 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). 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). Mazandaran University of Medical Sciences Approved 2019-11-17 Ethics committee of Mazandaran University of Medical Sciences Mazandaran University of Medical Siences (Vice chanchellor for research), Moallem Square Sari Mazandaran Iran (Islamic Republic of)