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The effect of Rose Damascene aromatherapy on sleep quality of patients hospitalized in the Cardiac Care Units

Protocol summary

Study aim
The purpose of this study is to investigate the effect of Rose Damascene aromatherapy on sleep quality of patients hospitalize in the cardiac care units.
Design
This study is a control clinical trial. Sixty patients admit to the CCU who are qualify for study are randomly divide into intervention and control groups.
Settings and conduct
Several studies have been carried out on the effectiveness of aromatherapy in improving sleep quality. Which have reported different results. In this study, 60 cardiac care units patients of those hospitals which are affiliate to Qom University of Medical Sciences are randomly divide into intervention and control groups. Patients of the intervention group will smell the Rose Damascene aroma for three nights and the control group patients receive routine care. The data collector is blind to which participant is in the group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients has ability to communicate, patient has normal orientation (time, place and person), patient has hemodynamic stability, Exclusion criteria: Patients have history of allergy or allergy to plants.
Intervention groups
This is a clinical trial with two intervention and control groups. Patients in the intervention group smell the Rose Damascene aroma and patients in the control group receive routine care.
Main outcome variables
The main consequence of this study is the sleep quality of patients.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170516033998N3
Registration date: 2018-03-10, 1396/12/19
Registration timing: registered_while_recruiting

Last update: 2018-03-10, 1396/12/19
Update count: 0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Kurosh Jodaki
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3320 9072
Email address
kjodaki@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Rose Damascene aromatherapy on sleep quality of patients hospitalized in the Cardiac Care Units
Public title
The effect of Rose Damascene aromatherapy on sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients have ability to communicate Patient know to time, place and person Patient has hemodynamic stability Sleep, Antidepressant, and Diuretics have not been received within the last 12 hours Do not drink stimulants such as coffee in the last 12 hours No pain due to illness No history of allergy to plants
Exclusion criteria:
Patients have history of allergy to plants Patients have pain due to illness
Age
From 18 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
  • Investigator
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, Random allocation is done by randomize blocking method. In this method, in order to be able to compare individuals and maintain equilibrium of the samples in groups, by randomize blocking method, participants in the study are divide into two equal groups. Block sizes are also randomly select (block 2, 4, 8), which In each block there are equal numbers of participants in each group. For example, in a 4-d piece block, 2 blocks belong to the intervention group and 2 blocks belong to the control group. Or in a 8-d piece block, 4 blocks belong to the intervention group and 4 blocks belong to the control group. Blocks are also randomly select to prevent disclosure of the last allocation in each block. For example, the select block is a 4-d piece, Which for each person to study is take a tab from inside the 4-d piece block and accidentally assign to one of the intervention or control groups and this process continues until the tabs in the block are complete. Again, the 4-d piece block is return to the drawer desk and to select the group of other participants, a block is randomly select from among the remaining blocks, which may be 8-d piece block, 4-d piece block, and this process continues until the sample size is complete.
Blinding (investigator's opinion)
Single blinded
Blinding description
This single blind study and the person who collects the data is blind to the study groups.
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
No. 83, Street No. 4, Safashahr Street, Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2017-12-05, 1396/09/14
Ethics committee reference number
IR.MUQ.REC.1396.119

Health conditions studied

1

Description of health condition studied
Sleep Quality
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sleep quality
Timepoint
At the beginning of the study and 72 hours after the intervention
Method of measurement
St. Mary's Hospital Sleep Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The researcher will use the Rose Damascene aromatherapy to affect the quality of sleep among patients. For three nights, the researcher tied three drops of Rose Damascene aroma on a paper towel and connected it to the patient's cloth, close to his head, with a pin. It remains on counterpane for 8 hours (from 10 pm to 6:00 am). After three nights of aroma therapy, the fourth morning of the study, the sleep quality of the intervention group is measured. The Rose Damascene aroma is from Barij Essence Co., Iran.
Category
N/A

2

Description
Control group: The control group receives routine care such as noise and light reduction. The fourth morning of the study, the sleep quality of the control group is measured.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Kurosh Jodaki
Street address
Shahid Chamran Street, Shahid Beheshti hospital, Qom
City
Qom
Province
Ghoum
Postal code
3719965657
Phone
+98 25 3320 9074
Email
kuroshjodaki@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr Saghafi
Street address
No. 83, Street No. 4, Safashahr Street, Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3320 9074
Email
kuroshjodaki@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Kurosh Jodaki
Position
mentor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Allied, Qom University of Medical Sciences Pardis, Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3320 9074
Email
kuroshjodaki@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Kurosh Jodaki
Position
mentor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Allied, Qom University of Medical Sciences Pardis, Qom.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3320 9074
Email
kuroshjodaki@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Kurosh Jodaki
Position
mentor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Allied, Qom University of Medical Sciences Pardis, Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3320 9074
Email
kuroshjodaki@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Shared data including demographic and disease information, type and method of intervention, information about sleep quality of participants before and after intervention.
When the data will become available and for how long
Start the access period 6 months after the results are published
To whom data/document is available
Researchers and people working in nursing education as well as nursing clinical staff
Under which criteria data/document could be used
The data can be used for education, research and clinical nursing. The applicant must be in the nursing field The data applicant only uses data for teaching, research and clinical nursing.
From where data/document is obtainable
Qom University of Medical Sciences, School of Allied, Qom. Email: kuroshjodaki@gmail.com Tel: 00989905514601
What processes are involved for a request to access data/document
After ensuring that the data applicant is in the nursing field, we will be immediately responded to the request form by email.
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