Determine the effectiveness of rose water on the anxiety level and Hemodynamic index of elderly admitted to cardiac care unit
Design
Clinical trial with control group, randomized, parallel group design with 52 patients
Settings and conduct
Patients will be selected from the cardiac intensive care unit of Shaheed Mostafa Khomeini Hospital, Tehran, Iran. In control group, 40 cc of water will be placed in container at the patient's bedside table. The intervention group, 40 cc of rose water will be placed in container at the patient's bedside table. These procures will be done in two nights from 22 to 6 o'clock in the morning.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Having cardiac disease; More than 60 years old; Desired cognitive status: Having cognition health (score higher than 7 based on Cognitive Short Test); No history of allergy to medicinal herbs; lack of asthma and any respiratory distress recorded in the file.
Exclusion criteria: Participating simultaneously in similar study
Intervention groups
In control group, 40 cc of water will be placed in container at the patient's bedside table. The intervention group, 40 cc of rose water will be placed in container at the patient's bedside table. These procures will be done in two nights from 22 to 6 o'clock in the morning.
Main outcome variables
Anxiety level; Hemodynamic index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170313033047N2
Registration date:2018-09-01, 1397/06/10
Registration timing:prospective
Last update:2018-09-01, 1397/06/10
Update count:0
Registration date
2018-09-01, 1397/06/10
Registrant information
Name
Maryam Jadid Milani
Name of organization / entity
Nursing Faculty of Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 8589
Email address
milani@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-06, 1397/06/15
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rose water on the anxiety level and Hemodynamic index of elderly admitted to cardiac care unit
Public title
The effect of rose water on the anxiety level and Hemodynamic index
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 60 years
Having cognition health (score higher than 7 based on Cognitive Short Test)
No history of allergy to medicial herbs
lack of asthma and any respiratory distress recorded in the file
Exclusion criteria:
Participating simultaneously in similar study
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method by flipping a coin will be used to determine the test and control groups. Then, convenience sampling method will be used for sampling within groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
There are two groups in research: intervention and control. Both of them will receive routine care. In intervention group, inhalation of rose water will be used by patients .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.Shahed.REC.1396.123
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety Score on Hamilton's Anxiety Rating Scale
Timepoint
Measurement of anxiety at the beginning of the study (before the intervention), on the morning of the second day and on the morning of the third day
Method of measurement
Hamilton's Anxiety Rating Scale
2
Description
Blood pressure
Timepoint
Measurement of blood pressure at the beginning of the study (before the intervention), on the morning of the second day and on the morning of the third day
Method of measurement
Mercury pressure gauge device
3
Description
Heart rate
Timepoint
Measurement of heart rate at the beginning of the study (before the intervention), on the morning of the second day and on the morning of the third day
Method of measurement
Watch
4
Description
Respiratory rate
Timepoint
Measurement of respiratory rate at the beginning of the study (before the intervention), on the morning of the second day and on the morning of the third day
Method of measurement
Watch
Secondary outcomes
empty
Intervention groups
1
Description
Control group: For two nights, 40 ml of ordinary water will be placed in a disposable bowl on the bedside table and will remain beside the patient from 22:00 to 6 am. Intervention group: For two nights, 40 ml of rose water will be placed in a disposable bowl on the bedside table and will remain beside patient from 22:00 to 6 am. As the scent of the rose water will spread in the area and could have an effect on the outcome of the study in the control group, two groups cannot be selected at the same time. Therefore, flipping a coin will be used to determine which group will be started first. Based on the coin, whichever group wins will be the first to start. After the research is conducted on the initial group which won the coin, sampling will be done for the next group. But, if the first group was the intervention group, sampling of control group will be started after three days. This three day period would ensure complete removal of any traces of the rose water scent in the study environment.