The effect of High flux with increasing blood flow rate on hemodialysis sleep quality
Design
Using a random allocation software, 50 eligible patients were divided into two groups of test and control groups, for the test group, flux filter and the rounds of the pump of 350-250 ml / min were used. The control group will undergo routine dialysis. The Pittsburgh questionnaire will be completed by interview method at the beginning and after the study.
Settings and conduct
Hemodialysis department of Shahid Ranmon Hospital
Participants/Inclusion and exclusion criteria
The desire to participate in the study
Having a history of hemodialysis for at least six months
Perform hemodialysis 3 times per week for 4 hours
Having no heart disease
Age range 25-70years
Exclusion criteria:
Transfer to another health center
Blood pressure less than 60/100
Patients with a history of sleep disorders of more than 7 according to the Pittsburgh Sleep Inventory
Moderate and severe pain (score greater than 3 based on the numerical value of pain).
Intervention groups
50 dialysis patients with sleep disorders eligible who were randomly allocated into two groups of test and control, were control group with routine method and test groups by increasing the speed of the pump and the flux filters dialysed
Main outcome variables
sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180703040322N1
Registration date:2019-01-09, 1397/10/19
Registration timing:retrospective
Last update:2019-01-09, 1397/10/19
Update count:0
Registration date
2019-01-09, 1397/10/19
Registrant information
Name
Shahrbanoo Ghasemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4427 1241
Email address
sh.ghasemian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
2018-03-06, 1396/12/15
Actual recruitment end date
2018-04-20, 1397/01/31
Trial completion date
2018-04-20, 1397/01/31
Scientific title
The effect of High flux with increasing blood flow rate on hemodialysis sleep quality in Shahid Rahnemoon Hospital of Yazd
Public title
The effect of High flux with increasing blood flow rate on hemodialysis sleep quality in Shahid Rahnemoon Hospital of Yazd
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study
Having a history of hemodialysis for at least six months Perform dialysis
Perform hemodialysis 3 times per week for 4 hours,
Having no heart disease
Age range 25-70 years
Exclusion criteria:
Transfer to another health center
Blood pressure less than 60/100
Patients with a history of sleep disorders of more than 7 according to the Pittsburgh Sleep Inventory
Moderate and severe pain (score greater than 3 based on the numerical value of pain).
Age
From 25 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Actual sample size reached:
50
More than 1 sample in each individual
Actual sample size in each individual:
25
26 people in each group
Randomization (investigator's opinion)
Randomized
Randomization description
52 samples were selected according to inclusion and exclusion criteria.
After obtaining informed consent from patients to participate in the research using code 01 to code 052 instead of the name of each patient used.
Then, with random allocation software, randomly assigned to two groups of intervention and control divided.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants were unaware of the allocation of study groups
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Department of Nursing, Nursing- Midwifery School, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
916877443
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
ir.ssu.rec.1396.196
Health conditions studied
1
Description of health condition studied
hemodyalis patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep quality is between 0 and 21, which means that the higher the score is, the lower the sleep quality.
Timepoint
0 and after 45 day
Method of measurement
Pittsburgh Questionnaire
Secondary outcomes
1
Description
hemodialysis quality
Timepoint
0 and after 45 days
Method of measurement
Laboratory indicators
Intervention groups
1
Description
Intervention group: "Intervention group:" 25 hemodialysis patients who were randomly assigned to the intervention group were hemodialized under dialysis with high flux and increses blood flow for 45 days.
Category
Treatment - Devices
2
Description
"control group": 25 hemodialysis patients was dialysed routinely for 45 days.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rahnemoon Hospital of Yazd
Full name of responsible person
shahrbanoo ghasemian
Street address
Department of Nursing, Nursing- Midwifery School, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
yazd
Province
Yazd
Postal code
کد پستی:916877443
Phone
+98 35 3824 1754
Email
ghasemian2040@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
دکتر مسعود میرزایی
Street address
Department of Nursing, Nursing- Midwifery School, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
yazd
Province
Yazd
Postal code
916877443
Phone
+98 35 3824 1754
Email
far.farnia@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr.Farahnaz Farnia
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Department of Nursing, Nursing- Midwifery School, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
916877443
Phone
+98 35 3824 1754
Email
far.farnia@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
shahrbanoo ghasemian
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Department of Nursing, Nursing- Midwifery School, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
yazd
Province
Yazd
Postal code
کد پستی:916877443
Phone
+98 35 3824 1754
Email
ghasemian2040@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
shahrbanoo ghsemian
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Department of Nursing, Nursing- Midwifery School, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
yazd
Province
Yazd
Postal code
916877443
Phone
+98 35 3824 1754
Email
ghasemian2040@gmail.com
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only the original outcome data will be available
When the data will become available and for how long
unknown
To whom data/document is available
Researchers at university centers
Under which criteria data/document could be used
Any analysis on the delivered data is allowed. Agreed with the researcher by email for other matters.
From where data/document is obtainable
Yazd University of Medical Sciences
What processes are involved for a request to access data/document
Applying from the university research vice president