The effect of cognitive-emotional intervention on the psychological distress, growth and post-traumatic stress of mothers of children with cancer who referred to the chemotherapy department
The purpose of this study was to reduce the psychological distress and post-traumatic stress in mothers with children undergoing chemotherapy
Design
A clinical trial with a control group, pragmatic, with parallel groups, randomized
Settings and conduct
This is a clinical trial study that will be conducted at Ali ibn Abitaleb Hospital in Zahedan. First, by diagnosing cancerous children who are referred to the Department of chemotherapy in 2018, and eligible mothers with the desired characteristics of the target population, eligible participants will be chosen Then the subjects will completed the informed consent form to participate in this study. The selected mothers will be randomly assigned into two intervention and control groups. The pre-test will be done by completing the psychological distress, post-traumatic growth and post-traumatic stress disorder questionnaires by two groups. The intervention group will receive five sessions of the emotional cognitive education program in two sessions per week in the form of small groups discussion based on the content. After 12 weeks, the research questionnaires will be completed as a post-test by visiting the subjects at home or by an appointment at department of Oncology.
Participants/Inclusion and exclusion criteria
Inclusion crieteria: Atleast 20 years old for mothers, at least the reading and writing skills for mothers
Exclusion Criteria: Not receiving even a single dose chemotherapy step for a child, advanced and severe illness of children
Intervention groups
Intervention group: 5 sessions of 90 minutes of cognitive-emotional training program are received based on specified content. Control group: receive regular training during the intervention period.
Main outcome variables
Post-traumatic growth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160924029954N12
Registration date:2018-10-25, 1397/08/03
Registration timing:prospective
Last update:2018-10-25, 1397/08/03
Update count:0
Registration date
2018-10-25, 1397/08/03
Registrant information
Name
Ali navidian
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2482
Email address
alinavidian@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-01, 1397/08/10
Expected recruitment end date
2018-12-31, 1397/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive-emotional intervention on the psychological distress, growth and post-traumatic stress of mothers of children with cancer who referred to the chemotherapy department
Public title
The effect of cognitive-emotional training on psychological distress, growth and post traumatic stress in mothers of cancerous children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mother is at least twenty years of age.
Mother has the least reading and writing skills
The mother is not afflicted with psychiatric disorders.
Exclusion criteria:
The patient has not even received chemotherapy.
The disease of the child is advanced and intensive.
The mother does not have the consent to enter the study.
Age
From 20 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Firstly, eligible participants will be chosen according to inclusion criteria and will be listed. After obtaining informed consent, they will be randomly assigned to two groups of intervention and control in such a way that the chosen subjects will be assigned in to two groups through the random numbers table. The odd numbers are assigned to the intervention group and the even numbers to the control group.
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
Ethics committee of Zahedan university of Medical Sciences and Health Services
Street address
Administrative Complex of Medical Sciences Campus, Persian Gulf Blvd, Dr. Hesabi Square, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Approval date
2018-07-15, 1397/04/24
Ethics committee reference number
IR.ZAUMS.REC.1397.193
Health conditions studied
1
Description of health condition studied
Mental state of mothers of cancerous child
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Post-traumatic growth
Timepoint
Before intervention and three months after intervention
Method of measurement
Post Traumatic Growth Questionnaire
2
Description
Post Traumatic Stress
Timepoint
Before intervention and three months after intervention
Method of measurement
Post Traumatic Stress Check List
3
Description
Psychological Distress
Timepoint
Before intervention and three months after intervention
Method of measurement
Kessler questionnaire K-10
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will received five sessions of cognitive-emotional training twice a week for 90 minutes according the confirmed and determined contents. The contents of the emotional cognitive intervention in the first session includes an introduction of the disease, the psychosocial consequences of the disease, especially in the family, the process of disease treatment and the normalization of the emotional reactions in cancers. The second session includes teaching and exercising emotional disclosure techniques, exhausting emotions and self-regulating emotions. The third session includes fears and concerns about cancer and its recurrence, facilitating and exercising cognitive processing and conscious rumination. The fourth session includes a review of achievements and disadvantages following child illness, developing values and prioritizing values, redefining goals, and creating a new philosophy for life. The fifth session consists of spirituality, positive thinking, and teaching patience and endurance.
Category
Other
2
Description
The control group does not receive any counseling and training during this period. At that same time interval, the post-test intervention group is also conducted. After the end of the study, the contents of the training will be provided to the control group too.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb's Hospital, Zahedan, Iran
Full name of responsible person
Arsalan Latifi
Street address
Ali Ebne Abi Taleb's Hospital, Khalije Fars Blvd, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3723 0390
Fax
Email
Bsn.latifi@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor Mohammad Bakhshani
Street address
Administrative Complex of Zahedan Medical Science Campus، Persian Gulf Blvd، Dr. Hesabi Square، Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3723 0390
Email
bakhshani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Arsalan latifi
Position
Master Student in Psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing & Midwifery, Mashahir Square, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3723 0390
Email
Bsn.latifi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Navidian
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Nursing & Midwifery, Mashahir Square, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2482
Email
alinavidian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Arsalan latifi
Position
Master Student in Psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing & Midwifery, Mashahir Square, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3723 0390
Email
Bsn.latifi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participants information is confidential
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
the method of implementation of the plan is explained in the thesis
When the data will become available and for how long
The post-graduation study protocol is described in the thesis
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
The thesis is explained.
What processes are involved for a request to access data/document