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The effect of coping skills training and religious coping on quality of life in parents of children with chronic kidney disease

Protocol summary

Summary
The purpose of the study:The effect of coping skills training and religious coping on the quality of life of parents of children with chronic kidney failure aged 2 to 18 years; study design: Quasi-experimental study before and after the intervention group and the control group at the hospitals of Tehran University of Medical Sciences, Iran University of Medical Sciences, Shahid Beheshti University of Medical Sciences in Tehran (Mofid, Ali Asghar, Bahrami and Medical Center),randomly (50 parents of children admitted to hospitals Ali Asghar and Mofid as parents in the intervention group and 50 admitted to hospitals Children's Medical Center and Bahrami elected as the control group). Inclusion criteria:3 months past their child is diagnosed kidney failure ; Health care provider (father or mother); older than 18 years; the ability to speak, read and write in Farsi; Lack of any mental disorder; neurological or other chronic diseases; Lack of Chronic renal failure in the family members; residing in Tehran and Alborz Exclusion criteria: the stressful event (divorce, financial crisis, death of a parent members); Participation in the similar educational courses; Sample: two groups of 50 parents in the intervention group and the control group intervention group: teaching coping skills and religious coping orally (group of 5 to 8 members) 5 sessions of 45 minutes with the theme: first session: chronic kidney disease, the second and third: coping skills, the fourth and fifth: religious coping strategies control group: only teaching hospital routine (described disease, treatment options, how to take care of the catheter or fistula and diet) does not receive the intervention. Intervention time: Immediately after sampling, the primary outcome variable: quality of life for parents

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015111717972N7
Registration date: 2016-03-05, 1394/12/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-03-05, 1394/12/15
Registrant information
Name
Zahra Godarzi
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4407
Email address
godarziz@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehren University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of coping skills training and religious coping on quality of life in parents of children with chronic kidney disease
Public title
Coping skills and adaptability of religion education on the quality of life of parents of children with chronic renal failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:3 months past their child is diagnosed kidney failure ; Health care provider (father or mother); older than 18 years; the ability to speak, read and write in Farsi; Lack of any mental disorder; neurological or other chronic diseases; Lack of Chronic renal failure in the family members; residing in Tehran and Alborz Exclusion criteria: the stressful event (divorce, financial crisis, death of a parent members); Participation in the similar educational courses
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Name intervention and control groups and the name of the Hospital each randomly selected to be written on paper .

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Qods St., Keshavarz Blvd Tehran Research Office, 7th Floor
City
Tehran
Postal code
Approval date
2015-11-10, 1394/08/19
Ethics committee reference number
IR.TUMS.REC.1394.1136

Health conditions studied

1

Description of health condition studied
Kidney diesease
ICD-10 code
N18
ICD-10 code description
Use additional code, if desired, to identify underlying disease. Use additional code, if desired, to identify presence of hypertension. N18.1 Chronic kidney disease, stage 1 Kidney damage with normal or increased GFR (> 90 mL/min) N18.2 Chronic kidney dis

Primary outcomes

1

Description
Parents qualitiy of life
Timepoint
Before the study, after study, one and two months after the study
Method of measurement
Based on questionnaire of SF36

Secondary outcomes

1

Description
Coping skills and religious coping
Timepoint
Before the study, after study, one and two months after the study
Method of measurement
Based on questionnaires RCPOE, SF36

Intervention groups

1

Description
intervention group: received training sessions for standard or routine care education training sessions for five 45-minute sessions at regular intervals set by the parents to lecture, question and answer and explain, based on the calendar training program will be implemented. More training sessions this way: At the first meeting of chronic kidney disease is described in terms of diagnosis, treatment and care of children with chronic renal failure (content using the nursing literature and according to the specialty of nephrology adjustments accordingly) using PowerPoint and educational pamphlet states be.Then the second and third sessions to express their coping skills with children and chronic kidney disease with topics such as coping with everyday problems, manage the thoughts, feelings and behaviors resulting from everyday stress due to the imposition of patient care, anger management, Stress, anger and guilt and how to deal with behavioral coping sick child, the child's siblings and spouse will be taught by researchers (the material is made in consultation with a psychologist adjustments accordingly). Fourth and fifth sessions of training in the use of religious coping strategies used by the spiritual adviser to the parents will be taught the Quran and Hadith.
Category
Lifestyle

2

Description
Control group:Just standard or routine care training (explanation disease, diet, care of the catheter or fistula for dialysis and home care) introduce and do not any intervention in this group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Children's Hospital Medical Center
Full name of responsible person
Gudarzi
Street address
Tohid Sq، Tehran
City
Tehran

2

Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Gudarzi
Street address
Zafar st, Tehran
City
Tehran

3

Recruitment center
Name of recruitment center
Bahrami Children's Hospital
Full name of responsible person
Gudarzi
Street address
Nezam abad st, Tehran
City
Tehran

4

Recruitment center
Name of recruitment center
Mofid Hospital
Full name of responsible person
Gudarzi
Street address
Shariati st, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Dr Masud Yunesian
Street address
Keshavarz Blvd, over six floors, ghods street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Tehran 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
School of Nursing and Midwifery, Tehran University
Full name of responsible person
Mahdiye Larni
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Tohid Square, Nursing and Midwifery, Tehran
City
Tehran
Postal code
Phone
+98 21 2293 8583
Fax
Email
www.mahdiyel@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Zahra Gudarzi
Position
Master of nursing
Other areas of specialty/work
Street address
Tohid Square, Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 6105 4407
Fax
Email
godarziz@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran
Full name of responsible person
Zahra Gudarzi
Position
Master of Nursing faculty
Other areas of specialty/work
Street address
Tohid Square, Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6105 4407
Fax
-
Email
godarziz@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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