Protocol summary

Summary
This project is a non randomized clinical trial and the main objective goal of it is to determine the effects of coping skills training on religious coping, quality of life and sense of coherence in parents of children with chronic illnesses. Researcher is trying to teach coping skills to parents of children with chronic diseases (renal failure, diabetes and blood disease) may help to reduce their tension. The main outcome variables in this study included: religious coping, quality of life and sense of coherence. Parents of sick children will divide to two groups (experimental group in Hazrat Ali Asghar center and control group in Mofid children hospital). Information are collected using SF - 36, RCOPE, SOC and demographic questionnaires (include parents personal characteristics and the child's clinical profile) that are completed by parents. Parents demographic information include issues like gender, age, occupation, marital status, education level, economic status, number of children in family and clinical characteristics of children include age, gender, type of disease and type of assurance. Coping skills training will be provided by an expert person using speech techniques, play videos, pamphlets, and group discussion for test group. The class will be firmed when number of parents in experimental group reaches to 8 -12 people. Training sessions include training for Relaxation and Meditation, negative and positive feelings control and communication skills with oneself, with others, and with God and dealing with the stresses of life. Classes will take place during 4 sessions for 4 consecutive weeks (one meeting in each week - each session will last about two hours). Then the researcher will control utilizing the training matters by phone in experimental group. Questionnaires will be completed by parents at first (T1) and one month later(T2).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014061018046N1
Registration date: 2014-08-10, 1393/05/19
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-08-10, 1393/05/19
Registrant information
Name
Sedighe Khanjari
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8867 1613
Email address
khanjari.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2014-08-11, 1393/05/20
Expected recruitment end date
2014-12-11, 1393/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of coping skills training on religiouse coping, quality of life and sense of coherence in parents of children with chronic diseases.
Public title
The effect of coping skills training on religiouse coping, quality of life and sense of coherence in parents of children with chronic diseases.
Purpose
Health service research
Inclusion/Exclusion criteria
The inclusion criteria for family caregivers are: being older than 18 years;knowing how to read and understand the Persian language; not having a history or current psychiatric or neuropsychological disorders,never having been diagnosed with chronic disease. Exclusion criterion: not attending training sessions in trial groups.
Age
From 1 year old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran university medical science
Street address
Hemmat Hwy
City
Tehran
Postal code
Approval date
2014-06-08, 1393/03/18
Ethics committee reference number
101541

Health conditions studied

1

Description of health condition studied
Chronic Blood Disease
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Chronic Kidney Disease
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Diabetes mellitus
ICD-10 code
E10-E14
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
Religious Coping
Timepoint
Beforand After Intervention
Method of measurement
RCOPE Questioner

2

Description
Sense of Coherence
Timepoint
Beforand After Intervention
Method of measurement
SOC Questioner

3

Description
Quality of Life
Timepoint
Beforand After Intervention
Method of measurement
SF - 36 Questioner

Secondary outcomes

1

Description
Quality of life
Timepoint
before and after intervention
Method of measurement
sf - 36 questioner

2

Description
Sense of coherence
Timepoint
before and after intervention
Method of measurement
SOC questioner

3

Description
Religious coping
Timepoint
before and after intervention
Method of measurement
RCOPE Questioner

Intervention groups

1

Description
Coping skills training will be provided by an expert person using speech techniques, play videos, pamphlets, and group discussion for test group. The class will be firmd when number of parents in experimental group reaches to 8 -12 people. Training sessions include training for Relaxation and Meditation, negative and positive feelings control and communication skills with oneself, with others, and with God and dealing with the stresses of life. Classes will take place during 4 sessions for 4 consecutive weeks (one meeting in each week - each session will last about two hours).
Category
Lifestyle

2

Description
The control group intervention will not recive intervention by the investigator and routine medical and nursing care will be done for them.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical, Educational And Therapeutic Center Of St. Aliasghar
Full name of responsible person
Street address
Above the Farid Afshar Ave - Vahid Dastjerdi street
City
Tehran

2

Recruitment center
Name of recruitment center
Mofid children's hospital
Full name of responsible person
Street address
Shariati Ave
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University Of Medical Science - Deputy of research and technology
Full name of responsible person
Dr. Seyed Ali Javad Moosavi
Street address
Hemmat Highway, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University Of Medical Science - Deputy of research and technology
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
Deputy Treatment of Shaheed Beheshti University
Full name of responsible person
Forough Mowla
Position
Ms Nursing
Other areas of specialty/work
Street address
Deputy Treatment Of Shaheed Beheshti University. Crossroud of Jomhori and Hafez st.
City
Tehran
Postal code
156993
Phone
+98 21 6676 1132
Fax
Email
enaghaie@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing And Midwifery Collage of Medical University of Iran
Full name of responsible person
Dr. Sedighe KHanjari
Position
Doctor
Other areas of specialty/work
Street address
Rashid Yasrmi Avenue. Valiasr St
City
Tehran
Postal code
156993
Phone
+98 21 8876 1613
Fax
Email
s-khanjari@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Deputy Treatment of Shaheed Beheshti University
Full name of responsible person
Forough Mowla
Position
Ms Nursing
Other areas of specialty/work
Street address
Deputy Treatment of Shaheed Beheshti University, Crossroud of Jomhori and Hafez st.
City
Tehran
Postal code
Phone
+98 21 6676 1132
Fax
Email
enaghaie@gmail.com
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
empty
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