The comparison of effects of Aromatherapy with Rose and Lavender on the Quality of Sleep in patients after CABG in Dr. Heshmat Hospital in Rasht, 2017-2018
Design
Clinical trial study, Phase 2, randomized, triplicate and control group, each group of 34 patients was designed in the period of 2017-2018.
Settings and conduct
The statistical population is the patients after open heart surgery in the surgical wards of Heshmat Hospital in Rasht, Iran
Participants/Inclusion and exclusion criteria
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.
By accessing patients' entry criteria, they are enrolled in the study. As far as possible, the same conditions for patient care, control of light, sound, and traffic in the desired areas were provided. Two sets of questionnaires are used to collect information. A questionnaire of demographic information that examines issues such as age, sex, education, marital status, underlying diseases, and a questionnaire of the Standard Sleep Quality Questionnaire (PSQI), which is used to determine the effect of inhalation on the flowering of lily of the valley and lily of the valley on the quality of sleep in patients Heart surgery is open after surgery.
Intervention groups
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.
Main outcome variables
Demographic information and sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180205038626N1
Registration date:2018-03-12, 1396/12/21
Registration timing:registered_while_recruiting
Last update:2018-03-12, 1396/12/21
Update count:1
Registration date
2018-03-12, 1396/12/21
Registrant information
Name
Zahra Ahmadnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3361 8177
Email address
zahmadnia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-24, 1396/12/05
Expected recruitment end date
2018-05-26, 1397/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Supportive
Inclusion/Exclusion criteria
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:
Age
To 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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 Guilan University of Medical Sciences
Street address
Dr. Heshmat Hospital - Valiasr Square, Bayani St.
City
rasht
Province
Guilan
Postal code
4193955588
Approval date
2018-02-10, 1396/11/21
Ethics committee reference number
IR.GUMS.REC.1396.450
Health conditions studied
1
Description of health condition studied
Patients post cardiac artery bypass surgery
ICD-10 code
I97.1
ICD-10 code description
Other functional disturbances following cardiac surgery
Primary outcomes
1
Description
sleep quality
Timepoint
6 days after aromatherapy with Rose and Lavender
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
1
Description
Another variable was not evaluated
Timepoint
The timing of the outcome measurement was not specified
Method of measurement
Another variable was not evaluated
Intervention groups
1
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Heshmat Rasht Hospital
Full name of responsible person
zahra ahmadnia
Street address
Dr. Heshmat Rasht Hospital - Valiasr Square, Baniyan St.
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Fax
+98 13 3361 8177
Email
zahmadnia@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
shadman nemati
Street address
Rasht, Namjoo Ave., Shahid Siadati St., Faced to the 17th Shahrivar Hospital, Old Building, School of Health, University of Technology Research and Technology
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 5820
Fax
+98 13 3333 6395
Email
zahmadnia@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
zahra ahmadnia
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Rasht Hospital - Valiasr Square, Baniyan St.
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Email
zahmadnia@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
zahra ahmadnia
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Rasht Hospital - Valiasr Square, Baniyan St.
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Email
zahmadnia@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
zahra ahmadnia
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Rasht Hospital - Valiasr Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Email
zahmadnia@gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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.
When the data will become available and for how long
Between 21:00 and 23:00
To whom data/document is available
For scholars working in academia and academia
Under which criteria data/document could be used
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.
From where data/document is obtainable
Dr. Heshmat Rasht Hospital - Valiasr Square, Baniyan St.
What processes are involved for a request to access data/document