This study is a double blind clinical trial To investigate the effect of cool dialysis on post-dialysis fatigue syndrome in Arak Vali -asr .
The number 46 of patients with end-stage renal disease will be selected according to the criteria with purposive sampling And will be simple random sampling in both groups A and B . Each patient will hemodialysis in group A, three times a week (every other day) with a dialysate temperature of 37 ° C and then in the second week three sessions (every other day) with temperature 35/5° C.
group B is In contrast to group A. At the end of each dialysis session will be completed once Piper Fatigue Scale for each patient.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014082518928N1
Registration date:2015-02-12, 1393/11/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-12, 1393/11/23
Registrant information
Name
Zohreh Gholami
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 951 2250
Email address
z.gholami@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Arak University of Medical Sciences
Expected recruitment start date
2014-09-13, 1393/06/22
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cold dialysate on post-dialysis fatigue syndrome
Public title
The effect dialysate temperature reduce on dialysis patients fatigue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years, diagnosis end stage renal disease, Having a degrees from fatigue, , regular visit three times a week for dialysis ,Hemodialysis treatment for at least 6 months, stable hemodynamic conditions ,Willingness to participate in the study. Hearing ability, speech and consciousness acceptable to answer the questions, Absence of cardiovascular disorders such as myocardial infarction, non-anemia H b<8
exclusion criteria:
Unwillingness to continue treatment, complications during dialysis requires immediate medical attention, The loss of one of the inclusion criteria, the problem of vascular access, The incidence of severe cardiac problems during dialysis,Chills so severe that the patient is not able to continue dialysis, severe and uncontrollable vomiting.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Arak, Basij Square, pardis University of Medical Sciences, Faculty of Nursing and Midwifery
City
Arak
Postal code
3819693345
Approval date
2014-06-11, 1393/03/21
Ethics committee reference number
93-163-18
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
XIV
ICD-10 code description
N17-N19 Renal failure
Primary outcomes
1
Description
post diaysis Fatigue
Timepoint
After each three dialysis session
Method of measurement
piper fatigue scale
Secondary outcomes
1
Description
temperature
Timepoint
Before and after each dialysis session
Method of measurement
Mercury thermometer axillary
2
Description
Feeling cold and chills
Timepoint
During dialysis
Method of measurement
Monitoring patient
Intervention groups
1
Description
dialysate temperature will be reduced to 35/5° C for group A in the second week and for group B in the first week and all patients(CROSSOVER) will be undergoing hemodialysis for three sessions with each temperature (35/5 and 37 ° C)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Vali-asr
Full name of responsible person
Dr Mahbubeh. Sajjadi
Street address
Iran, Arak, Sardasht, Faculty of Nursing and Midwifery
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Arak University of Medical Sciences
Full name of responsible person
Mr.Babaie
Street address
Arak, Basij Square, pardis University of Medical Sciences
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Arak 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
Arak University of Medical Sciences
Full name of responsible person
zohreh gholami
Position
Nurse
Other areas of specialty/work
Street address
Arak, Basij Square, pardis University of Medical Sciences, Faculty of Nursing and Midwifery
City
Arak
Postal code
3819693345
Phone
+98 8618634173036
Fax
+98 33133147
Email
zms.1391@yahoo.com -ghzms.1391@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr mahbubeh sajjadi
Position
phd
Other areas of specialty/work
Street address
Arak, Basij Square, pardis University of Medical Sciences, Faculty of Nursing and Midwifery
City
Arak,
Postal code
3819693345
Phone
+98 86133136055
Fax
Email
mahbubehsajjadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
zohreh gholami
Position
Nurse
Other areas of specialty/work
Street address
Iran, Arak, Sardasht, Faculty of Nursing and Midwifery
City
Arak
Postal code
Phone
00
Fax
Email
zms.1391@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)