Development and Evaluation of Effectiveness of a Mindfulness-based program on resiliency, rumination, acceptance and improvement of psychological distress of mothers with cancerous children
The results of this study can be Determines whether the package of mindfulness designed to increase resilience, decrease the rumination, acceptance and improve the psychological symptoms of mothers of children with cancer is effective. In practical and practical terms, the results of this research can be used as an intervention to improve the psychological symptoms of mothers of children with cancer, while familiarizing researchers and therapists of the country with the theories, therapeutic approaches, and research areas. Existing, the effectiveness of this method as one of the newest methods of intervention in the treatment of parents of children with cancer in an Iranian sample.
Design
They are available through a sampling method of 30 individuals. They were randomly drawn and drawn in two groups of intervention and control Placed.
Settings and conduct
The statistical population includes mothers of children with cancer who are under treatment in the oncology section of Emam Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Mothers of children with cancer
Intervention groups
30 mothers were randomly selected and assigned to intervention and control group. After pre-test and responding to the questionnaires, the intervention group received mindfulness therapy during 8 90-minute sessions (based on the instructions). The protocol also allows for two sessions per week to be completed, which can be completed for one month). While the control group will not receive any treatment, after the end of the sessions, a two-month follow up will be conducted to measure the efficacy of the treatment at a specified time in both groups. Finally, in order to observe ethical principles in the research, the knowledge of mind will be provided to the control group.
Main outcome variables
Mindfulness; Resiliency; Rumination; Acceptance; Mothers; Cancerous Children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180830040906N1
Registration date:2019-01-02, 1397/10/12
Registration timing:registered_while_recruiting
Last update:2019-01-02, 1397/10/12
Update count:0
Registration date
2019-01-02, 1397/10/12
Registrant information
Name
Zeinab Sinaefar
Name of organization / entity
Shahid beheshti university
Country
Iran (Islamic Republic of)
Phone
+98 21 4466 4341
Email address
sanazsinae@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-15, 1397/09/24
Expected recruitment end date
2019-01-14, 1397/10/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development and Evaluation of Effectiveness of a Mindfulness-based program on resiliency, rumination, acceptance and improvement of psychological distress of mothers with cancerous children
Public title
Development and Evaluation of Effectiveness of a Mindfulness-based program on resiliency, rumination, acceptance and improvement of psychological distress of mothers with cancerous children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
mothers with cancerous children
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population includes mothers of children with cancer who are under treatment in the oncology section of Imam Khomeini Hospital in Tehran. They are available through a sampling method of 30 individuals. They were randomly drawn and drawn in two groups of intervention and control Placed.
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 for Bioethics at Shahid Beheshti University
Street address
Institute of Cognitive and Brain Sciences, Shahid Beheshti University, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2018-12-01, 1397/09/10
Ethics committee reference number
IR.SBU.ICBS.97/1029
Health conditions studied
1
Description of health condition studied
Children with cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Resiliency
Timepoint
Pre-test-Post-test
Method of measurement
CD-RISC
2
Description
Rumination
Timepoint
Pre-test-Post-test
Method of measurement
RRS
3
Description
Acceptance
Timepoint
Pre-test-Post-test
Method of measurement
AAQ_II
4
Description
Psychological Distress
Timepoint
Pre-test-Post-test
Method of measurement
DASS-21
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A package of interventions based on the training of mindfulness skills was performed on the intervention group over 90 minute- 8 sessions.
Category
Lifestyle
2
Description
Control group:Do not get an intervention
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Seyed Mohammad Kazem Nourbakhsh
Street address
Imam Khomeini Hospital, Dr. Gharib Street, End of Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
dr.nourbakhsh2010@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Dr. Babak Shokri
Street address
Deputy Director of Research and Technology, Presidential Building, Shahid Beheshti University, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 29901
Email
drbabakshokri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University
Proportion provided by this source
100
Public or private sector
Private
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
Shahid Beheshti University
Full name of responsible person
Zeinab Sinaefar
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Phase1,Ekbatan
City
Tehran
Province
Tehran
Postal code
1393753931
Phone
+98 21 4466 4341
Email
sanazsinae@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Dr Saeed Imani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Room 320, Third Floor, Faculty of Educational Sciences and Psychology, Shahid Beheshti University, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
756555557509
Phone
+98 21 2990 5318
Email
psychology2008@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Zeinab Sinaefar
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Ekbatan, faze 1
City
Tehran
Province
Tehran
Postal code
1393753931
Phone
+98 21 4463 4341
Email
sanazsinae@gmail.com
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
Not applicable
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
Study documentation will be published after the intervention.
When the data will become available and for how long
september 2019
To whom data/document is available
All undergraduate and postgraduate students
Under which criteria data/document could be used
For researchers and students
From where data/document is obtainable
sanazsinae@gmail.com
What processes are involved for a request to access data/document