The effect of lifestyle education on the quality of life of dialysis patients
Design
Clinical trial with control group, double-blind, randomized by random number table on 60 patients
Settings and conduct
This study is a double-blind clinical trial that will be performed in the dialysis ward of Hojjat Koohkamari Hospital in Marand. After selecting the individuals according to the entry and exit criteria, random and blind allocation will be done in the intervention and test groups. The study is blind will be completed.
Then, the members of the intervention group will receive lifestyle trainings twice a week for 6 sessions of 30 minutes in a face-to-face method with 6 questions. Then, both groups will be followed up for 12 weeks. After 12 weeks, the quality of life questionnaire for dialysis patients will be completed for both groups. It should be noted that the intervention will be performed by the researcher but, the completion of the questionnaires will be done by another person who will be blind to the intervention and control groups
Participants/Inclusion and exclusion criteria
Age 18 to 65 years
History of dialysis for more than one year
No mental illness
Physical-motor disability
Intervention groups
Lifestyle training intervention that will be done in 6 sessions of 30 minutes face to face with questions and answers during dialysis.
Main outcome variables
Change in quality of life score
Change in life style score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220504054733N1
Registration date:2022-05-09, 1401/02/19
Registration timing:registered_while_recruiting
Last update:2022-05-09, 1401/02/19
Update count:0
Registration date
2022-05-09, 1401/02/19
Registrant information
Name
Soraya Soheili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 4225 8854
Email address
soraya.soheili@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-07, 1401/02/17
Expected recruitment end date
2022-06-07, 1401/03/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lifestyle educational interventions on quality of life of patients undergoing hemodialysis
Public title
The effect of lifestyle education on the quality of life of dialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years
Dialysis history of at least one year
Exclusion criteria:
No mental illness
Physical-motor disability
Unwillingness
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
First, according to the medical record, from all patients, people who are eligible to enter the study will be selected. Then, according to the phone number listed in the patient's file, they will be contacted gradually to provide them with the necessary explanations about the study plan and confirm the desire of people to participate in the project. Contact people until completion. The number of samples will continue. After completing the number of samples, by simple randomization method by random number table, people will be placed in intervention or control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
After fully explaining the plan, how to do it and its purpose to the participants and obtaining informed consent will be randomly placed in the intervention and control groups. Also, data collection by a trained person who will be blind to the intervention and control groups Was to be accepted.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University-Tabriz Branch (Research Ethics Committee)
Street address
No 31,narmak 1,kashani Ave
City
Marand
Province
East Azarbaijan
Postal code
5413633536
Approval date
2021-12-07, 1400/09/16
Ethics committee reference number
IR.IAU.TABRIZ.REC.1400.171 شماره طرح در سامانه دانشگاه (کد پژوهشی):1400916
Health conditions studied
1
Description of health condition studied
renal failure, hemodialysis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
سطح کیفیت زندگی بیماران تحت همودیالیز بر اساس پرسشنامه کیفیت زندگی بیماران دیالیزی
Timepoint
Measurement of quality of life before and 12 weeks after the intervention in the intervention and control groups
Method of measurement
Quality of life questionnaire for dialysis patients
Secondary outcomes
1
Description
lifestyle score
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Walker Health Promoting Lifestyle Questionnaire
Intervention groups
1
Description
The intervention is in the form of exercises related to a healthy lifestyle for the intervention group, which will be done in 6 sessions of 30 minutes face to face with questions and answers in the patient's bed and during hemodialysis twice a week. The content of the sessions will be on topics such as diet, physical activity, a sense of responsibility for personal health, attention to spiritual growth and self-sufficiency, interpersonal relationships and stress management. The content of the meetings will be as follows. Session 1: Communicating between people, the importance and necessity of a healthy lifestyle in everyday life Session 2: Lifestyle education and its components, review of factors affecting lifestyle and self-management education Session 3: Training on the effect of nutrition on health with the cooperation of a nutritionist, familiarity with the food pyramid, training on food calories and their impact on health and explaining meals and snacks Session 4: Review and training of exercises that affect health with the cooperation of a physical education expert and explain the importance of exercise in the prevention of various diseases and even in the treatment of some diseases Session 5: Familiarity with the role of sleep and adequate rest in health and the introduction of correct patterns of sleep hygiene, relaxation training, concentration and positive mental imagery to affect the improvement of disease Time management training, stress management Session 6: Summarizing and reviewing the contents. At the end of the sessions, individuals in both groups will be followed for 12 weeks to ensure the application of the training given by the intervention group and no specific changes in the lifestyle of the control group. Follow-up will be done in the form of a phone call.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis ward, Hojjat Koohkamari Marand Hospital
Full name of responsible person
Soraya Soheili
Street address
No31,narmak1,kashani Ave
City
Marand
Province
East Azarbaijan
Postal code
5413633536
Phone
+98 41 4229 2236
Email
soraya.soheili@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Soraya Soheili
Street address
No31, narmak 1, kashani Ave
City
Marand
Province
East Azarbaijan
Postal code
5413633536
Phone
+98 41 4229 2236
Email
soraya.soheili@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Marand Branch
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Soraya Soheili
Position
member of faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No31, narmak 1, kashani Ave
City
Marand
Province
East Azarbaijan
Postal code
5413633536
Phone
+98 41 4229 2236
Email
soraya.soheili@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Soraya Soheili
Position
member of faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No31, narmak1, kashani Ave
City
Marand
Province
East Azarbaijan
Postal code
5413633536
Phone
0098 41 4222936
Email
soraya.soheili@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Soraya Soheili
Position
member of faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No31, narmak 1, kashani Ave
City
Marand
Province
East Azarbaijan
Postal code
5413633536
Phone
0098 41 4222936
Email
soraya.soheili@yahoo.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