Study of the effect of educational supportive group therapy on quality of life among hemodialysis' patients
Design
The present interventional study was a semi-experimental one which was performed on pre-test and post-test in intervention and control groups. The study population was all hemodialysis patients of Shohada Ashayer Hospital (Khoramabad, Iran). 60 patients were selected by convenient method of sampling and divided into two groups of control and intervention based on the weekly days (patients undergoing dialysis on Saturdays, Mondays and Wednesdays in the intervention group and dialysis patients on Sundays, Tuesdays and Thursdays in the control group).
Settings and conduct
The experiment group received eight 50-70 min sessions including two sessions per week. The control group received the normal interventions. The participants were assessed using a demographics form and Kidney Disease Quality of Life Short Form before, immediately after, and one month after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Have a history of hemodialysis for more than 6 months
2. Have a desire to participate in study
3. Be able to read and write
4. Age 18 to 65 years
Non-entry criteria:
1. History of kidney transplantation
2. History of attending similar classes
3. Existence of physical disabilities such as deafness, blindness
Intervention groups
Group therapy was performed for 8 sessions twice a week. In each session, 15 members of the intervention group participated. The control group received only the usual interventions in the department.
Main outcome variables
Hemodialysis patients' quality of life in intervention and control groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181216041997N1
Registration date:2020-05-25, 1399/03/05
Registration timing:retrospective
Last update:2020-05-25, 1399/03/05
Update count:0
Registration date
2020-05-25, 1399/03/05
Registrant information
Name
Sajad Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3365 2345
Email address
sjdmansouri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2018-05-22, 1397/03/01
Trial completion date
2018-12-22, 1397/10/01
Scientific title
Study of the effect of educational supportive group therapy on hemodialysis patients' quality of life
Public title
The effect of educational supportive group therapy on quality of life
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have a history of hemodialysis for more than 6 months.
Have a desire to participate in research.
Be able to read and write.
Age 18 to 65 years.
Exclusion criteria:
History of attending similar classes
History of kidney transplantation
Existence of physical disabilities such as deafness, blindness
Age
From 32 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Actual sample size reached:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Beheshti ave. Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
657889909
Approval date
2018-05-08, 1397/02/18
Ethics committee reference number
IR.KUMS.REC.1397.043
Health conditions studied
1
Description of health condition studied
Quality of Life
ICD-10 code
N18.4
ICD-10 code description
Chronic kidney disease, stage 4 (severe)
Primary outcomes
1
Description
Quality of life
Timepoint
Before; Immediately after ; A month later
Method of measurement
Kidney disease quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: Group therapy with supportive-educative approach was performed in 8 sessions(70-80 min) twice a week for intervention group( 15 members groups).The sessions content was based on credible papers and sources on the assessment of quality of life in hemodialysis patients. Cognitive counseling techniques including emotional venting, interpersonal learning, self-awareness, clarification, restatement, reflection, self-awareness, role playing, and rotational and purposeful questions were used.Session 1: pretest, introduction and familiarization, clarifying the objectives of the sessions and the general structure, discussing the expectations, discussing the role of self-care and self-awareness in recovery process, and listening to the participants problems. Session 2: giving lecture and group discussion about chronic renal failure, hemodialysis, life with hemodialysis, giving time to the patients to express their feelings, viewpoints, and concerns, and answering the patients’ questions through group discussion. Home assignment: each patient was needed to report their experience with general health problems. Session 3: group discussion about the physical and mental side-effects of dialysis, prevention, and treatment, coping and attenuating the side-effects to preserve one’s social role and giving feedback to patients. Home assignment: To record one’s concerns and problems about everyday activities and interactions with others. Session 4: Group discussion about the third session home assignment and emotional and sensory intervention. This session was aimed at educating the participants about relaxation methods along with positive mental image to decease probable tensions of the day. Sessions 5 and 6: emotional and mental intervention; the main theme was to educate the participants about identifying their emotions and feelings and how to express them. In addition, the participants were encouraged to vent their suppressed emotions and feelings and in return the instructor and group members showed they sympathy and gave feedback. In addition, the importance of being independent, self-care, quality of social interactions, having a positive and good feeling, spiritual beliefs, and the role of pain and agony in life and the constructive effect of spiritual beliefs in alleviation of pains were reminded to the participants. Session 7: Spiritual interventions; the main theme of this session was care from spiritual viewpoint. The role of pain and agony in life and its constructive effect and development and expansion of ethical merits were examined. The relationships of man and nature, man and God, and man and the environment were also discussed. Session 8: Summarizing, concluding, answering the participants’ questions, and giving a general review of the previous session. Before concluding the course, the authors showed their gratitude to the participants.
Category
Lifestyle
2
Description
Control group: The patients of control group received only the usual interventions in the ward and no intervention was made by the researcher.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-ye Ashayer's hospital, Khoramabad
Full name of responsible person
Farah Piriaee
Street address
Enghelab
City
Khoramabad
Province
Lorestan
Postal code
6576543
Phone
+98 66 3323 6402
Email
Shohadahospital@lums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Amir Jalali
Street address
Dolatabad
City
Kermanshah
Province
Kermanshah
Postal code
657889909
Phone
+98 83 3816 2181
Email
Fac_n.m@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
AmirJalali
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dolatabad
City
Kermanshah
Province
Kermanshah
Postal code
657889909
Phone
+98 83 3816 2181
Email
a_jalali@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amir Jalali
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dolatabad
City
Kermanshah
Province
Kermanshah
Postal code
657889909
Phone
+98 83 3816 2181
Email
a_jalali@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
AmirJalali
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dolatabad
City
Kermanshah
Province
Kermanshah
Postal code
657889909
Phone
+98 83 3816 2181
Email
a_jalali@kums.ac.ir
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
No more information
Study Protocol
Undecided - It is not yet known if there will be 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
Yes - There is 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
Title and more details about the data/document
Data are available in the general form of study results
When the data will become available and for how long
from Jan. 2020
To whom data/document is available
researchers and university centers
Under which criteria data/document could be used
All results are available in the form of a study report a without any conditions
From where data/document is obtainable
Sajad Mansouri
Email: sjdmansouri@gmail.com
What processes are involved for a request to access data/document