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Investigation the effectiveness of comprehensive nursing care on uremic pruritus, sleep quality and dialysis adequacy in patients undergoing hemodialysis treatment

Protocol summary

Study aim
Determining the effect of comprehensive nursing care on uremic rash, sleep quality and dialysis adequacy in hemodialysis patients
Design
This study is a controlled clinical trial (single-blind) with a control group, with parallel groups, one blind, randomized on 70 patients in hemodialysis patients undergoing treatment in the hemodialysis department of Ali Ibn Abitaleb Hospital (A.S.). They are Zahedan, who have consented to participate in this research and meet the criteria for entering this study.
Settings and conduct
The research sample includes all hemodialysis patients undergoing treatment in the hemodialysis department of Ali Ibn Abi Talib (AS) Zahedan Hospital.Before the intervention, the demographic characteristics form, the degree of itching by completing the 5-dimensional scale of itching and their sleep quality through the Pittsburgh sleep index standard questionnaire, as well as the adequacy of dialysis is measured based on the formula. The control group will receive routine nursing and the intervention group will receive comprehensive nursing and after 3 months againare re-examined
Participants/Inclusion and exclusion criteria
Inclusion :Having a history of hemodialysis for at least three months before Having arteriovenous fistula... Exclusion:refusal to participation in the research death, travel
Intervention groups
The intervention group will receive comprehensive nursing, necessary training for the intervention group in five sessions, which include: health education, nutritional guidance, dialysis care (before, during and after dialysis), psychological interventions and daily care, which lasts 3 months will be done and the control group will receive routine nursing care.
Main outcome variables
uremic rash, sleep quality, dialysis adequacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231021059797N1
Registration date: 2023-11-13, 1402/08/22
Registration timing: registered_while_recruiting

Last update: 2023-11-13, 1402/08/22
Update count: 0
Registration date
2023-11-13, 1402/08/22
Registrant information
Name
atefeh fahraji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3326 0926
Email address
atefeh.fahrajii@zbum.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2024-02-04, 1402/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effectiveness of comprehensive nursing care on uremic pruritus, sleep quality and dialysis adequacy in patients undergoing hemodialysis treatment
Public title
Investigation the effectiveness of comprehensive nursing care on uremic pruritus, sleep quality and dialysis adequacy in patients undergoing hemodialysis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the research over 18 years of age Having a history of hemodialysis for at least three months before Having arteriovenous fistula Not suffering from heart diseases, infectious diseases, diseases related to other serious disorders at least one month before the study Performing hemodialysis three times a week for four hours each time The same type of ultrafiltration of filter and round device during the study for each patient Absence of liver problems No drug addiction
Exclusion criteria:
Withdrawal from participation in the pageant death, travel Getting other diseases (infectious, cardiac, etc.) while doing research The need to use drugs that affect uremic itching and their sleep quality while conducting research. Having skin diseases or sleep disorders while doing research Change in the dialysis pattern (number of sessions, dialysis hours, filter type, dialysis machine cycle, etc.) for any reason Being in the link list Drug use during the research period
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, first, a list of patients who meet the research inclusion criteria will be prepared, and then by random allocation, the first person selected will be in the intervention group and the second person will be in the control group. It will be continued that all research samples are in one of two intervention or control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be conducted as a controlled clinical trial (single-blind, meaning that the subjects do not know which of the groups they are in).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zabul University of Medical Sciences
Street address
Sistan and Baluchistan province, Zabul city, 11 Ferdowsi St., next to the registry office
City
zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Approval date
2023-10-18, 1402/07/26
Ethics committee reference number
IR.ZBMU.REC.1402.081

Health conditions studied

1

Description of health condition studied
Patients treated with hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
Comprehensive nursing care
Timepoint
for 3 months
Method of measurement
through the researcher

Secondary outcomes

1

Description
uremic pruritus
Timepoint
for 3 months
Method of measurement
Itching 5-dimensional scale questionnaire

2

Description
sleep quality
Timepoint
for 3 months
Method of measurement
Pittsburgh Sleep Index Standard Questionnaire

3

Description
Adequacy of dialysis
Timepoint
for 3 months
Method of measurement
Calculate the amount KT/V

Intervention groups

1

Description
Intervention group:
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Ibn Abi Taleb (AS) Zahedan Hospital
Full name of responsible person
Dr.Kave Orei Yazdani
Street address
Persian gulf boulevard, Zahedan, Sistan and Baluchestan Province
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
info@sbmu.ac.ir
Web page address
https://alihos.zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Zabul University of Medical Sciences
Street address
Headquarters of Zabul University of Medical Sciences, Shahid Bagheri St, Jahad square, Zabol
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3222 5402
Email
info@zbmu.ac.ir
Web page address
https://zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol University of Medical Sciences
Proportion provided by this source
20
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
Zabol University of Medical Sciences
Full name of responsible person
Atefeh fahraji
Position
Master's student in internal surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Milan7, Saadi66,Saadi street, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813856365
Phone
+98 54 3326 0926
Email
atefeh.fahrajii@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Dr. Hossein Shahdadi
Position
Member of the academic staff of the university
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Next to the civil registry, 11 Ferdowsi St, Zabul city, Sistan and Baluchestan Province
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 3947
Email
zb5950@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Atefeh fahraji
Position
Master's student in internal surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Milan7, Saadi66, Saadi st, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813856365
Phone
+98 54 3326 0926
Email
atefeh.fahrajii@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There are no plans to publish
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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