The effect of peer support on hope, acceptance of disability and social relational quality in patients undergoing hemodialysis referred to hemodialysis centers affiliated to Shiraz University of Medical Sciences 2018-2019.
The purpose of this study was to determine the effect of peer support on hope, acceptance of disability and social relational quality in patients undergoing hemodialysis referring to educational centers of Shiraz University of Medical Sciences.
Design
This is an interventional study and one-blind randomized clinical trial with control group. The sample will comprise 128 male and female hemodialysis patients. . Patients will be randomly divided into two groups according to the paired or referenced person. The systematic random method will then be used to identify individuals to enter the groups.
Settings and conduct
The research environment in this study includes hemodialysis centers affiliated to Shiraz University of Medical Sciences. On the one hand, the blindness of the study will be used to collect data and complete the questionnaires with the help of a researcher who is not aware of the division of the groups. Also, a statistics specialist who performs data analysis will be blind to groups
Participants/Inclusion and exclusion criteria
Patients should undergo hemodialysis for at least 6 months to enter the study. People with heart problems and cognitive problems will not be included in the study.
Intervention groups
Patients in both control and intervention groups will receive routine hemodialysis care. In the intervention group, the topics include the provision of various types of social protection (psychological, emotional, informational, tangible and social support) by the peer group, changes in physical and psychological complications such as muscle cramps, problems with sleep and itching, proper nutrition and sexual problems.
Main outcome variables
Hope, Acceptance of disability, Social relational quality.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190126042498N1
Registration date:2019-04-20, 1398/01/31
Registration timing:prospective
Last update:2019-04-20, 1398/01/31
Update count:0
Registration date
2019-04-20, 1398/01/31
Registrant information
Name
Mostafa Jowkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4333
Email address
stud2520080604@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-04, 1398/02/14
Expected recruitment end date
2019-07-10, 1398/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of peer support on hope, acceptance of disability and social relational quality in patients undergoing hemodialysis referred to hemodialysis centers affiliated to Shiraz University of Medical Sciences 2018-2019.
Public title
The effect of peer support on hope, acceptance of disability and social relational quality in patients undergoing hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1.The age of the patients is between the ages of 18 and 60 years.
2.At least 6 months should be treated with hemodialysis.
3.Hemodializes at least 2 times a week and up to 3 times a week.
4.Willing to participate in the study.
Exclusion criteria:
1. The patient has advanced cardiovascular disease, such as heart failure and acute pulmonary edema.
2.The patient has sensory-neurological disorders such as hearing impairment and vision or cognitive impairment such as dementia.
3.The patient has drug addiction.
4. Patient faced with emotional crisis such as close relatives and divorce during the past 6 months.
5. Patients who are not willing to continue to work.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
After receiving the approval of the Ethics Committee of Shiraz University of Medical Sciences, the list of the research community is prepared according to the list of patients with active records in the selected hemodialysis centers of Shiraz University of Medical Sciences. Patients are randomly selected using random numbers tables. Then, to enter the groups, the days of the week are divided into two groups based on the random throwing of the coin. Accordingly, the patients were randomly assigned to one of the two control and intervention groups based on the pair and weekly days.
Blinding (investigator's opinion)
Single blinded
Blinding description
On the one hand, the blindness of the study will be used to collect the data and complete the questionnaires with the help of a researcher who is not aware of the division of the groups. Also, a statistics specialist who performs data analysis will be blind to groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Fars Province University of Medical Sciences and Health Services, Zand Avenue
At the beginning of the study and two months after the onset of peer support for hemodialysis patients
Method of measurement
Hope Snyder questionnaire
2
Description
Acceptance of disability score in acceptance of disability questionnaire
Timepoint
At the beginning of the study and two months after the onset of peer
Method of measurement
Acceptance of disability questionnaire
3
Description
Social relational quality score in social relational quality questionnaire
Timepoint
At the beginning of the study and two months after the onset of peer
Method of measurement
Social relational quality questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, in order to select the peer group, a list of hemodialysis patients from the selected hemodialysis centers of Shiraz University of Medical Sciences will be prepared and targeted and selected from among them who have the following conditions: willing to volunteer for participation In the study, they should be hemodialized for at least 6 months, have a good faculty, have the ability to organize sessions and have an interest in the leadership of the group, have a good relationship, are interested in education, are educated and willing to teach, while in the opinion of the expert physician Kidney and general practitioner of hemodialysis centers based on the evidence in the case, such as: Results of all tests and examinations, periodic medical and other specialists from complications of hemodialysis, the successful management of their disease. These criteria are based on the checklist according to the review of the texts and the standard terms of reference of the peer and according to the opinion of the professors. Finally, in order to provide peer support, 10 peers will be selected, who will be trained by the researcher during 3 two-hour training sessions. The first session focuses on the implications, the importance and benefits of peer support, the correct communication skills and how to provide tangible and peer support to the peer, and the second session on how to provide information support to peers (such as the necessary preparations and care before and after hemodialysis and activity At home and preventing the physical and psychiatric side effects of the disease). The third session also describes how psychosocial support is provided to peers as well as the peace of mind. Further questions are answered by their counterparts and their beliefs are corrected on the basis of scientific sources. At the end of each session, Given is discussed. The method of teaching a researcher will be lecture, question and answer, and use of whiteboard. After each training session, the peer group will practice their training and support as a way of acting in the presence of the researcher. Subsequently, in order to ensure the readiness of the peers and to harmonize their education, the researcher will examine how the peers will be supported, according to the checklist prepared according to the items expressed in the three sessions. In the following, a booklet of all the materials presented in the meetings is provided to their counterparts. After preparing the group of peers, the patients, according to the pair or person to visit, were randomly selected using coin tossing in two groups Control and intervention. The systematic random method will then be used to identify individuals to enter the groups. The control group will receive routine hemodialysis treatment. In the intervention group, the sessions will be held once a week for 2 hours for 8 weeks for each of the groups before the onset of hemodialysis. For each group, the peer will be selected randomly and by gender. The peer group will train and support your group face to face with group discussion, question and answer, and troubleshooting issues. People from the group who are absent from 2 or less than 2 sessions will receive the topics discussed at the meeting by telephone from the researcher or peer group. The method of formation and management of the support group will be the same in all three groups and the issues of conscientiousness and culture will be observed during the sessions. At the first session, patients' health problems will be asked and then, according to priority, the subjects in each group, separately for the next seven sessions of the program It will be customized. Topics include the provision of various types of social support (psychological, emotional, informational, tangible and social support) by the peer group, changes in physical and psychological complications such as muscle cramps, problems with sleep and itching, proper nutrition and sexual problems. At each session, when discussing a disorder, approaches to adapt to changes and problems, to adapt to the state of being and to construct a new concept of life, to emphasize the use of experiences and opinions of others. Teaching slowly, teaching about disease and practices Controlling it, clarifying values, teaching thinking and self-management of emotions, and planning pleasure-pleasing activities are also discussed at these meetings. The titles of the sessions are almost the same in all three groups. In group of peers, the researcher is a facilitator, which leads to the effectiveness of the group. The researcher is responsible for facilitating group discussion, providing accurate scientific information, focusing on the group's dynamic process (lack of a person's control over the discussion, encouraging all members to discuss and solve the problem, facilitating members' communications, etc.), providing feedback to members, and paying attention to Law enforcement in the group. To prevent leakage of information, control and intervention groups are placed in separate shifts for dialysis to not meet each other. Before and immediately after the end of the sessions, data are collected using a questionnaire.
Category
Lifestyle
2
Description
Control group: Patients in both control and intervention groups will receive routine hemodialysis care
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences- Namazi Hospital and Faghihi Hospital
Full name of responsible person
Nilofar pasyar
Street address
Namazi hospital, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3647 4254
Email
npasyar@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaeianzadeh
Street address
Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3647 4254
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Nilofar Pasyar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No.342, Behesht Ave.Tachara
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3647 4254
Email
Npasyar@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nilofar Pasyar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No.342, Behesht Ave.Tachara
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3647 4254
Email
Npasyar@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mostafa Jowkar
Position
master student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 7, Hijrat Street, Boulevard Azadi, shiraz Town
City
Shiraz
Province
Fars
Postal code
7143997487
Phone
+98 71 3647 4333
Email
mostafajowkar93@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The following ethical considerations are considered in the implementation of the plan:
- The principles of Helsinki in all stages of the study.
- The principle of anonymity regarding questionnaires and their encoding.
-Thank your permission from the relevant authorities at the college, university, and hospital.
-Increase keeping participants' information and encoding questionnaires.
- Understand the goals of the study and obtain informed consent from all participants.
-Free freely from study in case of reluctance to cooperate.
-Research results will be made available to participants and relevant organizations upon request.
When the data will become available and for how long
After the end of the study
To whom data/document is available
Research results will be made available to participants and relevant organizations upon request.
Under which criteria data/document could be used
The principle of anonymity regarding questionnaires and their encoding.
-Thank your permission from the relevant authorities at the college, university, and hospital.
-Increase keeping participants' information and encoding questionnaires
From where data/document is obtainable
Zand Street, Shiraz, Library of Shiraz Nursing and Midwifery Faculty. Mr. Qasemi Library Dept. Telephone: 00987136474254
What processes are involved for a request to access data/document
The request for data is sent to the library of the Nursing and Midwifery Faculty of Shiraz. The coordination is done after one week of data being sent to them.