Evaluation of the effect of geranium fragrance on sleep quality and vital signs of coronary artery patients admitted to cardiac intensive care units
Design
Randomized clinical trial, with a control group, parallel groups. The sample size is 60 patients that randomly will be assigned to control and intervention groups using the block randomization method.
Settings and conduct
This study will be performed in the critical care unites of Shahid Beheshti Hospital in Qom. In the aromatherapy group, three drops of Geranium essence will be poured on a tissue and pinned next to the patient's pillow so that they can inhale it from 10 pm to 6 am. In the control group, only routine care will be done, including teaching how to control anxiety and reduce ambient light and noise. Blinding will not be done in this study.
Participants/Inclusion and exclusion criteria
Hospitalization in cardiac intensive care unit and acute coronary syndrome
Intervention groups
The scent of geranium will be used for three nights for the patients of the intervention group.
Main outcome variables
Sleep quality, vital signs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150724023314N5
Registration date:2022-11-16, 1401/08/25
Registration timing:prospective
Last update:2022-11-16, 1401/08/25
Update count:0
Registration date
2022-11-16, 1401/08/25
Registrant information
Name
Mohammad Abbasinia
Name of organization / entity
Qom university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3242 4753
Email address
mabasiniya@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-21, 1401/08/30
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of geranium aromatherapy on sleep quality and vital signs of coronary artery disease patients admitted to critical care units
Public title
The effect of geranium aromatherapy on sleep quality and vital signs of coronary artery disease patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hoispitalization in the cardiac intensive care unit with a diagnosis of acute coronary syndrome
Exclusion criteria:
The patient refuses to participating in the study and Instability of the patient's vital signs
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to intervention and control groups using block randomized method. The link "https://www.sealedenvelope.com/simple-randomiser/v1/lists" will be used for block randomization. For this purpose, the target number of samples (90 samples including sample loss), number of groups (two groups A and B) and number of blocks (4) will be entered and the system will provide the researcher with a list of 4 blocks. Based on the output list, it will be determined in which group the patients who enter the study should be placed in order. Items A represent the intervention group and items B represent the control groups.
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 Qom University of Medical Sciences
Street address
Qom University of Medical Sciences, Saheli street, Qom.
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2021-03-14, 1399/12/24
Ethics committee reference number
IR.MUQ.REC.1399.300
Health conditions studied
1
Description of health condition studied
Ischaemic heart diseases
ICD-10 code
I20-I25
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
Sleep quality
Timepoint
Three consecutive nights from 10 pm to 6 am
Method of measurement
Pittsburgh questionnaire
Secondary outcomes
1
Description
Vital signs
Timepoint
Immediately before and 10 min after intervention
Method of measurement
With vital signs monitoring devices
Intervention groups
1
Description
Intervention group: In the aromatherapy group, three drops of Geranium essence will be poured on a tissue and pinned next to the patient's pillow so that they can inhale it from 10 pm to 6 am.
Category
Other
2
Description
Control group: In the control group, only routine care will be done, including teaching how to control anxiety and reduce ambient light and noise.