Protocol summary

Study aim
The effect of using cold dialysis solution on Subjective Hemodialysis Adequacy, sleep quality and Physiological variables during hemodialysis in patients with End-Stage Renal Disease (ESRD)
Design
The current research is a randomized controlled clinical trial study with a pretest-posttest design (40 people in each group).
Settings and conduct
The samples will be selected from the patients referring to the dialysis ward of Baqiyatollah and Mofarrah hospitals. The patients will be first selected in accordance with the inclusion criteria; then, after obtaining written consent from the patients and introducing and explaining the objectives to the research units by the researcher, the samples will be divided into two intervention and control groups of 40 people by simple random allocation. The present research will be a single-blind study. The blinded group in the present research will be the patients participating in the study. The control group will receive hemodialysis with a temperature of 37℃ and the experimental group will receive hemodialysis with a temperature of 35℃.
Participants/Inclusion and exclusion criteria
Over 18 years of age. Performing hemodialysis at least twice a week. Absence of physical or mental disability. Full consciousness and ability to hear and speak to answer questions. Lack of mental or emotional disorders that prohibit effective communication. Hemoglobin level > 8 mg/dL Lack of endocrine disorders (hypothyroidism and hyperparathyroidism) Lack of concurrent malignancy
Intervention groups
In order to conduct the present study, patients in the control group will be hemodialyzed for 4 weeks with standard hemodialysis (37°C) and in the intervention group for 4 weeks with cold hemodialysis (35°C).
Main outcome variables
Quality of sleep , Subjective Adequacy and physiological indicators

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230521058244N1
Registration date: 2023-09-13, 1402/06/22
Registration timing: registered_while_recruiting

Last update: 2023-09-13, 1402/06/22
Update count: 0
Registration date
2023-09-13, 1402/06/22
Registrant information
Name
Ali Hosseinzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4790 2200
Email address
hosseinzadeh.ah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-11, 1402/05/20
Expected recruitment end date
2023-10-12, 1402/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using cold dialysis solution on Subjective Hemodialysis Adequacy, sleep quality and Physiological variables during hemodialysis in patients with End-Stage Renal Disease (ESRD)
Public title
The effect of cold dialysis solution in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Performing hemodialysis at least twice a week Over 18 years of age Full consciousness and ability to hear and speak to answer questions Hemoglobin level > 8 mg/dL
Exclusion criteria:
Presence of concurrent malignancy Endocrine disorders (hypothyroidism and hyperparathyroidism) Patients with acute mental and physical problems (such as divorce, death of a loved one, financial problems, and developing new chronic disease) Getting an active infection in the body (such as a cold and other infectious diseases)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In the present research, the samples will be first selected using the convenience sampling method from hemodialysis patients (confirmed by a nephrologist) meeting the inclusion criteria; then, they will be randomly assigned to two intervention and control groups in such a way that some envelopes containing cards labeled M and C will be prepared and the participants will be asked to randomly choose one of the envelopes. The individuals who take the M card will be assigned to the intervention group, and those who take the C card will be assigned to the control group. Thus, the sampling will continue until reaching the determined sample size
Blinding (investigator's opinion)
Single blinded
Blinding description
The current research will be a single-blind study. The blinded group will be the patients participating in the study. The blinding will be performed in this way: The patients will receive the type of hemodialysis considered for them (both groups of patients receiving cold hemodialysis and conventional hemodialysis) in sealed coded envelopes without having any information about the type of hemodialysis, and considering the gradual decrease in the temperature of hemodialysis, the experimental group patients will not notice the temperature change.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Baqiyatallah Hospital
Street address
MollaSadra street , Vanak Square , Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2023-07-24, 1402/05/02
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.028

Health conditions studied

1

Description of health condition studied
patients with End-Stage Renal Disease (ESRD)
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease

Primary outcomes

1

Description
Subjective Hemodialysis Adequacy score of patients with with End-Stage Renal Disease in Subjective Hemodialysis Adequacy Questionnaire designed and psychometrically evaluated by Bi Niaz et al
Timepoint
before intervention and at the end of the intervention
Method of measurement
Subjective Hemodialysis Adequacy Questionnaire designed and psychometrically evaluated by Bi Niaz et al

2

Description
Richard Campbell sleep quality score of patients with with End-Stage Renal Disease
Timepoint
before intervention and at the end of the intervention
Method of measurement
"Richard Campbell sleep quality questionnaire"

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receive cold hemodialysis . The device temperature will be kept at 35℃ for 4 weeks.
Category
Treatment - Devices

2

Description
Control group: Patients receiving normal hemodialysis with a temperature of 37
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatullah Hospital
Full name of responsible person
Ali hosseinzadeh
Street address
MollaSadra street , Vanak Square , Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8804 0060
Email
Info@bmsu.ac.ir

2

Recruitment center
Name of recruitment center
Mofarah general hospital
Full name of responsible person
Ali hosseinzadeh
Street address
Yakhchiabad, Tendgoyan highway, Basir bridge, Bahmanyar square, Bahmani street
City
Tehran
Province
Tehran
Postal code
1891938911
Phone
+98 21 9132 0002
Fax
+98 21 9132 2960
Email
info@mofarahhospital.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Abbas Ali Imani Fuladi
Street address
MollaSadra street , Vanak Square , Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8804 0060
Email
Info@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
alihosseinzadeh
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
MollaSadra street , Vanak Square , Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8804 0060
Email
hosseinzadeh.ah@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Abolfazl Rahimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
MollaSadra street , Vanak Square , Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8804 0060
Email
fazel123@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Alihosseinzadeh
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
MollaSadra street , Vanak Square , Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8840 0060
Email
Hosseinzadeh.ah@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
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
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