Protocol summary

Study aim
The effect of spiritual care on the stress and burden of caring for mothers of children with cancer
Design
Quasi- experimental with a control group,
Settings and conduct
For the intervention group, 8 sessions of 20 to 30 minutes in person and groups of 3 to 5 people will be taken and the manual provided by the Spiritual Counseling Counselor will be given to the mothers of the intervention group at the stage of providing spiritual care. Then, immediately and one month after the end of the eighth session the Beck Anxiety and Bargaining Questionnaire will again be completed by the participants in the intervention and control group. It should be noted that there is no intervention for the control group and they will be under the usual care of the department. inventory will be completed by the mothers of the group at the beginning of the study and 4 weeks later. At the end of the study, the package will be provided to the participants of the control group.
Participants/Inclusion and exclusion criteria
B Muslim; passed at least 6 months from the diagnosis of a child's illness; failure to have mental illness; awareness of childhood disease; absence in the same sessions and classes; the child's presence and presence at least 10 days in the department; lack of other stressful events other than childhood during the past year.
Intervention groups
For the intervention group, 8 sessions of 20 to 30 minutes are performed face to face in groups of 3-5 women, and the instruction book provided by the Spiritual Counseling Counselor in the stage of providing spiritual care is given to the mothers of the intervention group at the first session. The control group also receives section routines.
Main outcome variables
Spiritual care

General information

Reason for update
Acronym
cancer
IRCT registration information
IRCT registration number: IRCT20160119026104N4
Registration date: 2018-12-16, 1397/09/25
Registration timing: registered_while_recruiting

Last update: 2018-12-16, 1397/09/25
Update count: 0
Registration date
2018-12-16, 1397/09/25
Registrant information
Name
Mahnaz Shoghi
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4687 1192
Email address
shoghi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of spiritual care based on the Sound Heart Model on the anxiety and burden of care in mothers of children with cancer
Public title
Effect of spiritual care on the anxiety and burden of care in mothers of children with cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be Muslim Passed at least 6 months from the diagnosis of a child's illness Awareness of childhood disease Absence in the same sessions and classes The child's presence and presence at least 10 days in the ward
Exclusion criteria:
History of psychological illness Other stressful events other than childhood during the past year-
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Tehran, Valiasr Ave., higher than Vanak Square, Rashidiassemi Avenue, Iran Nursing Midwifery Faculty
City
Tehran
Province
Tehran
Postal code
1996713883
Approval date
2018-08-26, 1397/06/04
Ethics committee reference number
IR.IUMS.REC.1397.359

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
Burden of care
Timepoint
The beginning of the study (before the study began) and one month later
Method of measurement
Zarit's Care Load Questionnaire

2

Description
Anxiety
Timepoint
The beginning of the study (before the study began) and one month later
Method of measurement
Beck Anxiety Inventory

Secondary outcomes

empty

Intervention groups

1

Description
A total of 86 children with cancer who are eligible to participate in the study will be selected using the available method and will be included in the study. After explaining the actions and obtaining the informed consent, in the first stage, "before intervention," the anxiety and care of the mothers of both intervention groups And control is measured by questionnaires. The second stage of "intervention" will be based on the model of the spiritual heart of the spiritual care. For prevention of inflammation, the information of the control group from a hospital and the intervention group will be selected from the other hospital. This intervention during the childhood admission of children in the hospital during the days when the conditions of the child, mother and child are allowed to run every day, which includes 8 sessions of 20 to 30 minutes in groups of 3-5 people, and a booklet prepared from the Spiritual Counseling Paper at the presentation stage Spiritual care was given to the mothers of the intervention group, and then they were given the first hearing of the Qur'an and the music of the rain, and they will be asked to listen to it through headphones or hangfra. The music is given to them and they are asked to listen to it every day. After the completion of the sessions, anxiety and emergency care questionnaires will be completed immediately and after one month by the intervention group participants. It should be noted that there is no intervention for the control group and they will be under the usual care of the department. At the end of the study, a manual will be provided and the voice packet will be provided to the control group participants
Category
Other

2

Description
Control group: Spiritual Care Booklet and Audio Pack
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Childrens medical center
Full name of responsible person
Tahereh Mohamadzadeh
Street address
Number 62, Childrens Medical Center, Dr. Qarib street, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1511419733
Phone
+98 21 6147 2917
Email
cmc.tums@gmail.com

2

Recruitment center
Name of recruitment center
Hazrat Ali Asghar Hospital
Full name of responsible person
Soroor Sohrabi
Street address
Ali Asghar hospital, Shahid Dasgerdi street
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2041
Email
soroor.soh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seid Kazam Malakuti
Street address
School of Nursing and Midwifery, Shahid Yasemi Street., North Kordestan Highway., Tehran., IRA
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
PR@iums.ac.ir
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 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
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Valiasr Ave, above Vanak Square, Rashid Yasemi Ave., Iran Nursing Midwifery Faculty
City
tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
shoghi.m@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
استاديار
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Shahid Yasemi Street., North Kordestan Highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
shoghi.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Shahid Yasemi Street., North Kordestan Highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
shoghi.m@iums.ac.ir

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
Not applicable
Title and more details about the data/document
After Data coding in order to keep the confidentiality of the participants in the research.
When the data will become available and for how long
The end of sampling till six months after article publishing.
To whom data/document is available
Ethical, Reviewer and Editorial committees, Researchers.
Under which criteria data/document could be used
Systematic review and meta-analysis or secondary analysis citation
From where data/document is obtainable
Mahnaz Shoghi, Email: shoghi.m@iums.ac.ir
What processes are involved for a request to access data/document
After sending a request to academic email, we will send our data files up to one week.
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