This study is a quasi-experimental clinical trial before and after (pretest – posttest) with the control group. In this study parents who meet the inclusion criteria and refer to oncology clinic of Medical Center of Children and Bahrami Hospital assign as control group and parents who refer to Ali Asghar and Mofid Hospital assign as experimental group. The samples are selected using convenience sampling. After explaining the purpose and method of the study, consent form to be complete by the subjects participating in the study. For the experimental group coping skills training including social communication skills will perform through four, 2 hours sessions for 4 consecutive weeks (one session per week). Education will be performed by small group discussion (5-8 members) and presenting by using PowerPoint. Session for each group at the hospital will be held on separate days. After the end of sessions, to the experimental group will be take the relevant educational pamphlets. The control group receives only the routine education of the hospitals. Data will be collected through three questionnaires including demographic characteristics, The Caregivers Quality of Life Index Cancer-Persian and The Sense of Coherence-13. For the control group the data will be collected through two phases pretest and posttest (four week later). The questionnaires will be completed through three phases: before, immediately and four weeks after the intervention in the experimental group. After data collection, the control group will be received educational pamphlets.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013062313748N1
Registration date:2013-08-01, 1392/05/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-01, 1392/05/10
Registrant information
Name
Sedigheh Khanjari
Name of organization / entity
Iran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
00982188211861, 00982166927171
Email address
s-khanjari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Tehran University of Medical Sciences
Expected recruitment start date
2013-02-23, 1391/12/05
Expected recruitment end date
2013-07-24, 1392/05/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of coping skills training on quality of life and sense of coherence in parents of children with leuckemia
Public title
The effect of coping skills training on quality of life and sense of coherence in parents of children with leuckemia
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Children aged 1-16 years; have experienced at least one course of chemotherapy; having a main family caregiver (father or mother); the parents 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 cancer of any type in close family member; residing in Tehran and Alborz.
Exclusion criteria: Occurrence and perceived stress of major life events (divorce, financial crisis, death of a family member); Participation in a special education.
Age
From 18 years old to 60 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research Tehran University of Medical Sciences
Street address
Ghods St., Keshavarz Ave., Tehran
City
Tehran
Postal code
Approval date
2013-02-04, 1391/11/16
Ethics committee reference number
130/2868/د/91
Health conditions studied
1
Description of health condition studied
leukemia
ICD-10 code
C91, C92
ICD-10 code description
Lymphoid leukaemia, Myeloid leukaemia
Primary outcomes
1
Description
Quality of Life
Timepoint
Immediately and four weeks after the intervention
Method of measurement
The Caregivers Quality of Life Index Cancer- Persian
2
Description
Sense of Coherence
Timepoint
Immediately and four weeks after the intervention
Method of measurement
Sense of Coherence-13
Secondary outcomes
empty
Intervention groups
1
Description
For the exprimental group coping skills training including social communication skills will perform through four, 2 hours sessions for 4 consecutive weeks (one session per week). Education will perform by group discussion (discussion in small groups consist of 5-8 members) and presenting by using powerpoint. Session for each group at the hospital, will be held on seprate days. After the end of sessions, to the exprimental group will be take the relevant educational pamphelets.
Category
Other
2
Description
The control group receive only the routin education of the hospitals.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Childrens Medical Center Hospital
Full name of responsible person
Street address
No.62, Next to Imam Khomeini Hospital, Doctor Mohammad Gharib St., Keshavarz Ave., Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Street address
Vahid Dastgerdi Martyr St.(Zafar), Ayatollah Modares Highway, Tehran
City
Tehran
3
Recruitment center
Name of recruitment center
Bahrami Children's Hospital
Full name of responsible person
Street address
Kayani Martyr St., Damavand St., Imam Hossein Sq, Tehran
City
Tehran
4
Recruitment center
Name of recruitment center
Mofid Children's Hospital
Full name of responsible person
Street address
Front of Ershad Hosseinieh, Dr. 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
Sedigheh Khanjari
Street address
Ghods St., Keshavarz Ave., Tehran
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
Iran University of Medical Sciences
Full name of responsible person
Sedigheh Khanjari
Position
Faculty Member / Assistant Professor
Other areas of specialty/work
Street address
Next to Milad Tower, Hemmat Martyr Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 8821 1861
Fax
Email
s-khanjari@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sedigheh Khanjari
Position
Professor Assistant
Other areas of specialty/work
Street address
Next to Milad Tower, Hemmat Martyr Highway, Tehran
City
Tehran
Postal code
Phone
+98 912 738 7239
Fax
Email
s-khanjari@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Somayeh Borji
Position
Nursing MSc Student
Other areas of specialty/work
Street address
Ghods St., Keshavarz Ave., Tehran
City
Tehran
Postal code
Phone
+98 912 841 5116
Fax
Email
s-borji@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)