Protocol summary

Summary
1-objectives: 1-The Effect of Educational-Spiritual Intervention on the Burnout of the Parents of School Age Children with Cancer admitted in Shiraz hospital Amir.1392, 2- The comparison of the mean burnout scores of the parents of children with cancer before, after and one month after, 3-The comparison of the mean burnout scores of the fathers and mothers of children with cancer, 4-validity and stability of Shirom & Melamed Burnout Questionarry 2-design: This study is a clinical trial. 140 parents of children with cancer who refer to Amir hospital in Shiraz randomly assigned to experimental and control groups.(70 case and 70 control)Data collection included SMBQ (Shirom and Melamed Burnout Questionnaire) which was given to both groups, before, immediately after and one month after intervention. Educational-Spiritual programs were held for six weeks, one session every week. 3- Inclusion: diagnose cancer in child by a doctor; child age is 6-12; not a single parent famiy: Informed consent to participate in research; Participate in all training session exclusion: death; physical and mental conditions; unwillingness of parents 4- Intervention: The first session: introduction and expression of the objectives of the research, familiarity with cancer, the detection and treatment of cancer, remission symptoms, second session: the effects of various treatments, daily activities, diet, control complications of treatment of children with cancer, third and fourth sessions : religious education about life and death, fifth Session Six: acceptance of divine destiny and patient After completing the training program Burnout Inventory will compete the questionarry by both group again. At the end of the sessions, training manual will be give the control group. 5-main outcome measures: Burnout

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014061818144N1
Registration date: 2015-01-13, 1393/10/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-13, 1393/10/23
Registrant information
Name
Parisa Nasirpour
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 4520 5229
Email address
nasirpur_p@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Shiraz University of Medical Sciences
Expected recruitment start date
2014-01-22, 1392/11/02
Expected recruitment end date
2014-06-20, 1393/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Educational-SpiritualIntervention on the Burnout of the Parents of School Age Children with Cancer
Public title
The Effect of Educational-SpiritualIntervention on the Burnout
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion: childhood cancer diagnosed by a doctor; Child age is 6-12; Not a single parent family; Lack of parental mental or physical illness; Read and write; Informed consent to participate in research; Participate in all training session exclusion: disease in parent; Child mortality; Unwillingness of parents
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
no
Secondary trial Id
no
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethic committee, Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz
City
Shiraz
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
926788

Health conditions studied

1

Description of health condition studied
burnout
ICD-10 code
Z73.0
ICD-10 code description
Z73.0 Burn-out

Primary outcomes

1

Description
Burnout
Timepoint
After and 1month after intervention
Method of measurement
Questionarry

Secondary outcomes

1

Description
Effect on mental disorder
Timepoint
Before and 1 month after
Method of measurement
In behavior of case

Intervention groups

1

Description
Intervention: Educational-Spiritual programs were held for six weeks, one session every week. The first session: introduction and expression of the objectives of the research, familiarity with cancer, the detection and treatment of cancer, remission symptoms, second session: the effects of various treatments, daily activities, diet, control complications of treatment of children with cancer, third and fourth sessions : religious education about life and death, fifth Session Six: acceptance of divine destiny and patient
Category
Treatment - Other

2

Description
control: At the end of the sessions, training manual will be give the control group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Oncology Hospital
Full name of responsible person
Dr.Zare
Street address
Amir OncologyHospital, Farhang shahr, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences- Vice Chancellor for Researchshiraz medical university
Full name of responsible person
Dr. Basir Hashemi
Street address
Vice Chancellor for Research, Zand street, Shiraz
City
Shiraz
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- Vice Chancellor for Researchshiraz medical university
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
Shiraz University of Medical Science, Fateme School of Nursing & Midwifery
Full name of responsible person
Nooshin Beheshtipour
Position
Instructor
Other areas of specialty/work
Street address
Fateme School of Nursing & Midwifery, Namazi Street
City
Shiraz
Postal code
Phone
+98 71 3647 4252
Fax
Email
beheshti64@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Science, Fateme School of Nursing & Midwifery
Full name of responsible person
Nooshin Beheshti pour
Position
master of nursing
Other areas of specialty/work
Street address
Fateme School of Nursing & Midwifery, Street Namazi, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3647 4542
Fax
Email
beheshti64@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Medical Science, Fateme School of Nursing & Midwifery
Full name of responsible person
Nooshin Beheshtipour
Position
Master of nusing-Instructor
Other areas of specialty/work
Street address
Namazi Street, Fateme School of Nursing & Midwifery
City
Shiraz
Postal code
Phone
+98 71 3647 4252
Fax
Email
beheshti64@yahoo.com & beheshtin@sums.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
empty
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