Purpose of the study:The purpose of this study was to evaluate the effect of cool dialysate on sleep quality of patients with chronic renal failure undergoing hemodialysis. Design: The study was a randomized single blind controlled clinical trial, done in the before and after treatment method. Methodology: Population: The study will be done on hemodialysis patients who go to dialysis ward of vasei hospital in sabzevar. After determining patients with sleep disorders, individuals are selected based on inclusion criteria. Inclusion criteria are Being on dialysis weekly list and do it two or three times a week and every three or four hours, Patients who have received score higher than 5 Pittsburgh Sleep Quality Index.and Having a history of at least six months hemodialysis. Exclusion criteria included acute complications (cardiac, respiratory arrest, Disequilibrium syndrome) and the lack of cold tolerance and the patient's unwillingness to continue to participate in the study. Interventions: The study will be done on 13 patients in the intervention group and 13 patients in the control group who had the inclusion criteria and were randomly divided. Blinding will be imposed on patients in both groups of this study. For four week, all patients in both groups will get hemodialysis with dialysis solution with standard temperature (37 ° C). Then, At the end of 12 hemodialysis will be completed by researcher Pittsburgh Sleep Quality Index for each of them. for four week, the experimental group will get hemodialysis with cold dialysis solution with temperature (35.5 ° C) and the control group will get hemodialysis with dialysis solution with standard temperature (37 ° C). Then, At the end of 12 hemodialysis will be completed by researcher Pittsburgh Sleep Quality Index for each of them.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060228219N1
Registration date:2016-10-30, 1395/08/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Roghayeh Ghanbarabadi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4522 1838
Email address
ghanbarabadir93@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of cool dialysate on sleep quality in patients undergoing hemodialysis
Public title
Effects of cool dialysate on sleep quality in patients undergoing hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: consent for participation in the study; Age older than 18 years and maximum 75 years; suffering from vision, hearing loss; not suffering from clear mental disorders and severe emotional mood disorders, which prevent effective communication; Patients with chronic renal failure (patients who 6 months have passed since their dialysis); Patients receiving dialysis treatment three times a week and each session for 4 hours; not suffering from endocrine disorders (such as hypothyroidism, hyperparathyroidism; Patients who have received score higher than 5 Pittsburgh Sleep Quality Index; Patients with hemoglobin levels are greater than 8 mg dl; Lack of debilitating diseases and disorders such as severe chronic heart, respiratory, hepatic, history of seizures and severe neuropathy based on medical records and patient history; Lack of psychiatric disorders (schizophrenia, anxiety, depression) or dementia Or stay in psychiatric wards because of the items listed; No history of kidney transplant; Exclusion criteria: Patients who develop acute complications during hemodialysis (Disequilibrium syndrome - embolism - dysrhythmia – cardiac, respiratory arrest - Coma -); patients who discontinued they dialysis for any reason; Patients who are referred for kidney transplants (Patients who get kidney transplantation during the study); the patient's death, patients who cannot tolerate cold dialysis; the patient's unwillingness to continue to participate in the study
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar University of Medical Sciences
Street address
Building Number two,Vice Chancellor for Education,Sabzevar University of Medical Sciences and Health
City
sabzevar
Postal code
0098514446070
Approval date
2016-07-14, 1395/04/24
Ethics committee reference number
ir.medsab.rec.1395.57
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
N18.5
ICD-10 code description
End stage kidney disease:on dialysis
Primary outcomes
1
Description
sleep quality
Timepoint
Before, during and after intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention/Control 1
CONTROL: temperature of hemodialysis fluid (dialysate) is regulated on 37 ° C . Type of filter, coefficient of ultra-filtration, blood flow rate and type of apparatus are constant during the study.
Intervention/Control 2
intervention: temperature of hemodialysis fluid is regulated on (35.5 ° C) and type of filter, coefficient of ultra-filtration, blood flow rate are not changed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
vasei hospital in sa bzevar
Full name of responsible person
Dr zahra mir hosyni
Street address
sabzevar
City
sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Musa Al-Reza Taday'oun far
Street address
Building number two, Vice Chancellor for Education, Sabzevar University of Medical Sciences and Health Services
City
sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Roghayyeh ghanbarabadi
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Building number two, Vice Chancellor for Education, Sabzevar University of Medical Sciences and Health Services
City
sabzevar
Postal code
00985144446070
Phone
+98 98514446070
Fax
+98 51 4444 6070
Email
Ghanbarabadi.r@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr Mustafa Rad
Position
PhD Student in Nursing
Other areas of specialty/work
Street address
Building number two, Vice Chancellor for Education, Sabzevar University of Medical Sciences and Health Services
City
sabzevar
Postal code
00985144446070
Phone
+98 98514446070
Fax
+98 571446070
Email
mostafarad633@ yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Roghayyeh ghanbarabadi
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Building Number two,Vice Chancellor for Education,Sabzevar University of Medical Sciences and Health
City
sabzevar
Postal code
0098571446070
Phone
+98 514446070
Fax
Email
Ghanbarabadi.r@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)