The aim of this study is to evaluate the effect of Damask rose extract on sleep quality and fatigue in hemodialysis patients.
Design
Among the available participants who are suitable considering to our inclusion criteria, will be divided into 2 groups: Intervention and control group.The Sample size will be 74 patients. Blind will not be done in this study.
Settings and conduct
The patients will be trained to provide three drops of Damask rose extract for one month, every night before bedtime, on cotton and attach them with a pin to their collar and take them off of their clothes after waking up.There will be no intervention for the control group. questionnaire will be handed to both groups before the intervention and one month after it.The place of study would be in Imam Reza hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
patients 18 to 65 year
hemodialysis history for at least 6 months
Performing hemodialysis at least three sessions a week
Exit criteria:
Suffering from diseases that are Olfactory disorder, Psychological problems that require to take medication, sleep disorder diseases (other than ESRD)
No alignment for performing aroma therapy more than three times a week
Intervention groups
intervention:The patients will be provided three drops of Damask rose extract for one month, every night before bedtime, on cottons and attach them with a pin to their collar.
control: Without intervention
Main outcome variables
sleep quality and fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110629006918N28
Registration date:2019-01-28, 1397/11/08
Registration timing:retrospective
Last update:2019-01-28, 1397/11/08
Update count:0
Registration date
2019-01-28, 1397/11/08
Registrant information
Name
Alehe Seyedrasooli
Name of organization / entity
Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 0365
Email address
seyyedrasooly@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Damask rose extract on sleep quality and fatigue in hemodialysis patients: a semi experimental study
Public title
The effect of Damask rose extract on sleep quality and fatigue
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having the minimum age of 18 and maximum of 65
Having a hemodialysis history for at least 6 months
Performing hemodialysis at least three sessions a week
Patient’s willing to participating in the study
Exclusion criteria:
Suffering from diseases that are Olfactory disorder,Psychological problems that require to take medication, sleep disorder diseases (other than hemodialysis or ESRD)
No alignment for performing aroma therapy more than three times a week
history of allergy to Damask Rose extract
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the eligible patients will be selected through convenience sampling technique and then randomized equally into the intervention (aroma therapy) and control groups, using randomized block design in two blocks of sizes 2 and 4 by a person blinded to the sampling. The interventions will be sealed in serially numbered opaque envelopes and the Datinf Randlist will be used to randomize the participants in the intervention and 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 Tabriz University of Medical Sciences
Street address
Shariety South St, Faculty of Nursing & Midwifery, Tabrize, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2018-07-31, 1397/05/09
Ethics committee reference number
IR .TBZMED .REC.1397.354
Health conditions studied
1
Description of health condition studied
fatigue
ICD-10 code
G93.3
ICD-10 code description
Postviral fatigue syndrome
2
Description of health condition studied
sleep quality
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
sleep quality
Timepoint
Sleep quality measurement will be done at the beginning of the study and one month after the intervention begins.
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
2
Description
Fatigue
Timepoint
Fatigue severity measurement will be done at the beginning of the study and one month after the intervention begins.
Method of measurement
FSS (Fatigue Severity Scale)
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: The intervention group will be trained to provide three drops of Damask rose extract (made by Kashan Barij Essence Pharmaceutical company), for one month, every night before bedtime, on prepared cottons and attach them with a pin to their collar and take them off of their clothes the next morning, after waking up.
Category
Prevention
2
Description
Control group: It would not be done any intervention in this group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Bahar Elahi
Street address
Gulgasht St, Imam Reza hospital,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
Bahar.elahi20@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Shariety South St, Faculty of Nursing & Midwifery of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
Bahar.elahi20@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Bahar Elahi
Position
MSN
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tabriz, Shariety South St
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 914 981 8980
Email
Bahar.elahi20@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Kobra Parvan
Position
Msn Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shariety South St, Faculty of Nursing & Midwifery, Tabriz,Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
parvank@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahar Elahi
Position
Msn Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shariety South St, Faculty of Nursing & Midwifery, Tabrize, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
51389447977
Phone
+98 914 981 8980
Email
Bahar.elahi20@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available