(1) Objectives: The effects of appropriate nutrition education in small groups on the laboratory values in the hemodialysis patients; To determination and compare two month the average laboratory values before and after training between the intervention and control groups with each other and within both intervention and control group
(2) Design: 32 control Person and 32 intervention Person, the total sample size of 64 people; Hemodialysis patients with sealed envelope draw in both intervention and control groups and parallel then in two days the pair (intervention) and oven (control) were randomly assigned.
(3) Setting and Conduct: 2 times in 2 months laboratory values before the training were inserted and then Training diet intervention groups (5 members) was carried out. values alternately in the two months after the intervention were inserted. Existence significant difference between before and after training, and the average difference between the intervention group and the control group as the effect of education was considered.
(4) Participants including major eliglibity criteria: age 18 to 70 years, without psychiatric disorder; Exclusion criteria: severity of illness, lack of willingness to cooperate and kidney transplant
(5) Intervention: 1. The intervention; Goals and how diet training that include the reduction of body wastes, regulate body water and electrolytes, allowance food and complications increase the authorized laboratory values in three one-hour sessions for a month were performed.
2. The control; did not receive training.
(6) main outcome measure: two month the average laboratory values before and after training between the intervention and control groups with each other and within both intervention and control group were compared.
General information
Acronym
nutrition education and laboratory values in the hemodialysis patients
IRCT registration information
IRCT registration number:IRCT2016082229481N1
Registration date:2016-12-28, 1395/10/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-28, 1395/10/08
Registrant information
Name
Seyede Leila Hoseini
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3376 0515
Email address
slhosseini@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-07-23, 1395/05/02
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of appropriate nutrition education in small groups on the laboratory values in the hemodialysis patients
Public title
The effects of appropriate nutrition education in small groups on the laboratory values in the hemodialysis patients
Purpose
Health service research
Inclusion/Exclusion criteria
Criteria for study:
1. age 18 to 70 years
2. No known psychiatric disorders and psychiatric treatment, according to a Psychiatrist Specializing
3. The absence of any cognitive impairment, speech or hearing
4. The lack of pain during training
5. dialysis in Zanjan
6. phone access
7. having full consent to participate in the study
8. The End-Stage Renal Disease that is constantly undergoing Hemodialysis program
9. two to three times a week for three to four hours is treated with dialysis
10. Having read and write at least
11. sick or disabled family members are able to understand and speak the Persian orTurkish or Azari language
12. caregivers of patients who have the greatest participation in the treatment of disease, and he spent the most time with and least education (literacy), respectively.
Exclusion criteria:
1. Used to treat kidney transplant during the study
2. migration from dialysis during the study
3. patient died during the study
4. who frequently ill during hemodialysis and hemodialysis have not been able to afford full-time
5. The incidence of severe deterioration and the development of critical situations for each of the samples during the study
6. Not wanting to take part in a training session or a follow-up sessions during the study
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
none
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
West Azerbaijan University of Medical Sciences
Street address
West Azerbaijan University of Medical Sciences, next to the Emergency, the end of Gahad Street, Resalat Boulvar, Urmia,Iran
City
Urmia
Postal code
5714783734
Approval date
2016-07-20, 1395/04/30
Ethics committee reference number
IR. umsu. rec. 1395. 138
Health conditions studied
1
Description of health condition studied
Chronic Renal Failuer Patients who need hemodialysis
ICD-10 code
XIV
ICD-10 code description
N18, N19
Primary outcomes
1
Description
the laboratory values BUN,Cr, Na, K, Ca, P
Timepoint
wo months before and two months after intervention
Method of measurement
five ml blood samples from patients and Biochemical reagents Company Bayvrks England
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:
Diet training program that includes three lecture one hour in unit hemodialysis Vali asr zanjan withe use educational tools
1. educational pamphlet proper diet supervised by a nutritionist
2. The CD contains a short educational videos for patients was conducted using computer
3. In the section with questions and answers from the patient and his entourage, the learning content taught was measured and, if necessary, further explanation was given
All content included:
1. kidney function
2.failure and its complications
3. diet goals: reducing waste in the body, providing enough food for growth and repair of body, regulate body water and electrolytes (sodium, potassium, calcium and phosphorus), the prevention of anemia, and balance blood urea and creatinine
4. The list of allowed and restricted food and fluid intake body
5. how to observe proper diet and fluid intake and Complications increase urea, creatinine, sodium, potassium, calcium, phosphorus
6. finally, non-compliance by the patient's diet: the accumulation of toxins and fluids in the body, increasing the workload of the kidneys, increase the risk of disease progression, impaired physical ability, depression, malnutrition, high blood pressure and death was and else.
In three one-hour sessions in four weeks (August) in the even-numbered days in small groups 5 members was performed. that in to six groups of five person and one groups of two person was divided
Control group: received no training and
routine care
Category
Lifestyle
2
Description
Control group: received no diet training and routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr educational and treatment center, Zanjan, Iran
Full name of responsible person
Seyede Leila Hoseini
Street address
Zanjan University of Medical Sciences
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyde Leila Hoseini
Street address
Ayatollah Mousavi educational and treatment center, Gavazng road, Zanjan, Iran
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Seyede Leila Hoseini
Position
Critical Care Nursing graduate student
Other areas of specialty/work
Street address
Ayatollah Mousavi educational and treatment center, Gavazng road, Zanjan, Iran
City
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
Mousavihospital@zums.ac.ir, SLhosseini@zums.ac
Web page address
www.zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
West Azerbaijan University of Medical Sciences
Full name of responsible person
Nader Aghakhani
Position
Nursing Ph.D, Members of the faculty
Other areas of specialty/work
Street address
Urmia Nursing and Midwifery School, 11 km Nazlo Road, Western Azerbaijan, Iran
City
urmia
Postal code
5714783734
Phone
+98 443223489
Fax
+98 44 3222 9059
Email
nader1453@umsu.ac.ir
Web page address
www.umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyde Leila Hoseini
Position
Critical Care Nursing graduate student
Other areas of specialty/work
Street address
Ayatollah Mousavi educational and treatment center, Gavazng road, Zanjan, Iran
City
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
Mousavihospital@zums.ac.ir, SLhosseini@zums.ac
Web page address
www.zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)