Protocol summary
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Study aim
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study of the effects of Aromatherapy with Rose and Lavender on the Quality of Sleep and Depression in patients after Coronary Artery Bypass Grafting
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Design
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Clinical trial study, Phase 2, randomized, triplicate and control group, each group of 34 patients was designed in the period of 2017-2018.
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Settings and conduct
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The statistical population is the patients after open heart surgery in the surgical wards of Heshmat Hospital in Rasht, Iran
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Participants/Inclusion and exclusion criteria
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The eligibility criteria included the following: age 65 years or less (based on the WHO age of 65 and older as an aging age, so as to ensure that the sense of aging is caused by aging), the patient's willingness to participate in the study, the lack of use Patients with anti-depressant drugs and narcotics, speeches of patients in Persian, having clear verbal ability, not having a history of known psychological disorders, having no history of allergic rhinitis and other respiratory and sinusitis problems, not having a history of effective systemic or chronic disease On the sense of smell or hearing and not having a history of sleep disorders and relying on non-use Eating drugs and hypnotics.
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Intervention groups
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The patients are randomly divided into 3 groups: the first group inhaled 2% lavender essence , the second group inhaled 2% rose essence, and the third group without any intervention.
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Main outcome variables
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Demographic information and sleep quality and Depression
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180205038626N1
Registration date:
2018-03-12, 1396/12/21
Registration timing:
registered_while_recruiting
Last update:
2019-01-29, 1397/11/09
Update count:
1
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Registration date
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2018-03-12, 1396/12/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-02-24, 1396/12/05
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Expected recruitment end date
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2018-05-26, 1397/03/05
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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study of the effects of Aromatherapy with Rose and Lavender on the Quality of Sleep in patients after CABG in Dr. Heshmat Hospital in Rasht, 2017-2018
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Public title
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study of the effects of Aromatherapy with Rose and Lavender on the Quality of Sleep in patients after CABG in Dr. Heshmat Hospital in Rasht, 2017-2018
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of 65 years or less (according to the WHO, the age of 65 and older is considered to be aged, so to ensure that the sense of aging is caused by aging), the patient's willingness to participate in the study, the inability of patients to use anti-depressant drugs and narcotics , Speaking of patients' language in Persian, having clear verbal ability, having no history of known psychological disorders, having no history of allergic rhinitis and other respiratory and sinusitis problems, having no history of certain systemic or chronic diseases, affecting the sense of smell or hearing and having no history Sleep disorders and reliance on non-use of medications and sleep apnea.
Exclusion criteria:
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Age
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To 65 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
34
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Since the nature of the interventions restricts the ability to run in a common room environment, it was decided that the rooms would randomly be randomized based on 6 random blocks and would be changed in three randomized rooms in order to eliminate potential confusion. In the eligible patients entered in each room, the intervention will be applied.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-02-10, 1396/11/21
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Ethics committee reference number
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IR.GUMS.REC.1396.450
Health conditions studied
1
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Description of health condition studied
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Patients post cardiac artery bypass surgery
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ICD-10 code
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I97.1
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ICD-10 code description
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Other functional disturbances following cardiac surgery
Primary outcomes
1
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Description
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sleep quality
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Timepoint
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6 days after aromatherapy with Rose and Lavender
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Method of measurement
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Pittsburgh Sleep Quality Index
Secondary outcomes
1
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Description
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Depression
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Timepoint
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6 days after aromatherapy with Rose and Lavender
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Method of measurement
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Beck Depression Inventory
Intervention groups
1
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Description
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Intervention group: The first group, a group of lavender essential oil, the second group is a group of medicinal herbs with a basil leaf essential oil.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Rasht University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Patients in the two groups of patients undergoing lavender and flower mourning therapy are asked to inhale the lavender and flower of Mohammadi, which is as much as three drops, for 5 nights each night during the period from 21 to 23 Put on a piece of cloth attached to the patient pillow. It should be noted that during the intervention period, people who develop symptoms such as dyspnea or allergic symptoms will be excluded from the study. Monitor the patient in the department by the partner of the patient and the nurse. Then the sixth day of the questionnaire of sleep quality assessment is completed by the researcher. The researcher in the control group completes the sleep quality questionnaire without any intervention the morning of the day after entering the surgical department and the sixth day of the sleep quality questionnaire.
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When the data will become available and for how long
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Between 21:00 and 23:00
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To whom data/document is available
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For scholars working in academia and academia
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Under which criteria data/document could be used
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After collecting data, SPSS-V.21 software is used to describe the data. Descriptive statistics (percentage) and mean (standard deviation) will be used. The normal distribution of quantitative amounts based on the Kolmogrov-Smironov test will be investigated. In order to compare the groups in terms of demographic characteristics, one-way analysis of variance (with Tukey's post hoc test) and Kruskal-Wallis test will be used if no normal distribution is made. In order to compare the groups in terms of qualitative demographic characteristics, the Chi-square test was used and for the qualitative variables of Kruskal-Wallis test (using the Man-Whitney post-mortem test along with the correction of Ben Freonny). To compare the mean sleep quality score in the three groups at the end of the intervention, the covariance analysis will be used by adjusting to the base sleep quality score and eliminating the effect of other adjuncts. In the absence of a condition for covariance analysis, stratified analysis will be used.
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From where data/document is obtainable
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Dr. Heshmat Rasht Hospital - Valiasr Square, Baniyan St.
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What processes are involved for a request to access data/document
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Through automation correspondence or email
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Comments
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