Determining the effect of "mindfulness-based stress reduction" intervention on chronic sorrow and coping behaviors in mothers of children with cancer in Mofid Children's Hospital
Design
Clinical trial with control and intervention groups, parallel groups, randomized, on 80 mothers of children with cancer. Random number table is used for randomization.
Settings and conduct
The study site is the oncology ward of Mofid Children's Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mother over 20 years old; 6 months have passed since the child was diagnosed with cancer and the mother is aware of the diagnosis; The child's cancer is in the extinction stage; Be Persian-speaking and literate; Physically and mentally able to answer questions and communicate.
Non-inclusion criteria:The mother or first-degree relatives (except the child) have cancer; Have cognitive, speech or hearing problems; Have a mental illness or anxiety disorder based on the child's records; have a degree in psychology and medical science.
Intervention groups
Intervention group: The members of this group undergo the mindfulness-based stress reduction intervention and learn relaxation and meditation techniques in 4 sessions. Control group: in the control group, mothers will not participate in mindfulness-based stress reduction sessions
Main outcome variables
Chronic Sorrow, Coping Behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200610047721N1
Registration date:2020-08-23, 1399/06/02
Registration timing:registered_while_recruiting
Last update:2020-08-23, 1399/06/02
Update count:0
Registration date
2020-08-23, 1399/06/02
Registrant information
Name
Mahsa Moslem
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3374 9035
Email address
m.moslem@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Mindfulness-Based Stress Reducing Intervention on the Rate of Chronic Sorrow and Coping Behaviors in Mothers of Children with Cancer
Public title
The Effect of Mindfulness-Based Stress Reducing Intervention on the Rate of Chronic Sorrow and Coping Behaviors
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be over 20 years old
Have a diagnosis of pediatric cancer by a oncologist doctor with a definite record in the patient's file
Mothers are aware of the diagnosis of their child's cancer.
Being the biological mother of the child.
The child's cancer is in the extinction stage.
At least 6 months have passed since the diagnosis of child cancer.
Being literate, have the ability to speak Persian.
Being physically and mentally able to answer questions and communicate.
Have consent to participate in the study.
Have the desire and ability to participate in face-to-face meetings.
Have access to mobile phones and familiarity with Mobogram or Talagram software.
Exclusion criteria:
The mother or first-degree relatives (except the child) have cancer.
The mother has cognitive, speech, or hearing problems.
Have a mental illness or anxiety disorder based on the child's records.
Have a degree (being educated) in psychology and medical sciences.
Age
From 20 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Sample selection is done in such a way that all eligible samples are listed, then each of them is given a number that was randomly derived from the table of random numbers. There is no special order in writing these numbers. Next, the required number of samples is randomly selected from the numbers by drawing numbers. In placing people in the control and intervention groups, the block randomization method is used, in which 16 blocks of size 5 are selected and then patients are divided into two groups of 40 people as control and intervention groups based on the sequence of numbers created from block randomization.
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 the Faculty of Pharmacy, Nursing and Midwifery - Shahid Beheshti University of M
Street address
Shahid Beheshti school of nursing and midwifery,in front of Shahid Rajaei hospital,Valiasr street
City
Tehran
Province
Tehran
Postal code
19857174443
Approval date
2020-05-03, 1399/02/14
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.034
Health conditions studied
1
Description of health condition studied
Leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]
2
Description of health condition studied
Brain tumors
ICD-10 code
C71
ICD-10 code description
Malignant neoplasm of brain
3
Description of health condition studied
Bone tumor
ICD-10 code
C40
ICD-10 code description
Malignant neoplasm of bone and articular cartilage of limbs
4
Description of health condition studied
Wilms tumor
ICD-10 code
C64
ICD-10 code description
Malignant neoplasm of kidney, except renal pelvis
5
Description of health condition studied
lymphoma
ICD-10 code
C77
ICD-10 code description
Secondary and unspecified malignant neoplasm of lymph nodes
Primary outcomes
1
Description
Mother's coping behaviors
Timepoint
Before the intervention (before the start of the first session of mindfulness-based stress reduction program) and after the intervention (four weeks after the intervention, ie after four sessions of mindfulness-based stress reduction program once a week).
Method of measurement
The McCobin's Coping Health Inventory for Parents (CHIP) Questionnaire
2
Description
Mother's chronic sorrow
Timepoint
Before the intervention (before the start of the first session of mindfulness-based stress reduction program) and after the intervention (four weeks after the intervention, ie after four sessions of mindfulness-based stress reduction program Once a week).
Intervention group: The purpose of the intervention in this study is to hold four sessions with the content of stress reduction based on mindfulness for mothers. The content of the sessions is the first session including introduction, expression of feelings and thoughts, body scan meditation, the second session includes body scan exercise, Three-minute breathing, the third session includes repeating the previous sessions and doing yoga movements. Finally, in the fourth session, the exercises will be reviewed and after completing the sessions, the questionnaires will be completed again. The sessions will be held once a week for a period of 45-120 minutes.
Category
Behavior
2
Description
Control group: in the control group, mothers will not participate in mindfulness-based stress reduction sessions and will only complete the Coping Health Inventory for Parents (CHIP)and Kendall Chronic Sorrow Instrument Questionnaire.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid children's hospital
Full name of responsible person
Mahsa Moslem
Street address
Before Mirdamad street, near by Hosseinieh Ershad; Shariati street
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Fax
+98 21 2222 0254
Email
info-mch@sbmu.ac.ir
Web page address
http://en.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Street address
Shahid Beheshti school of nursing and midwifery,in front of Shahid Rajaei hospital,Valiasr street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5363
Email
mhdolatian@gmail.com
Web page address
http://nm.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahsa Moslem
Position
Master student of pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti school of nursing and midwifery,in front of Shahid Rajaei hospital,Valiasr street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5363
Email
sbnmf@sbmu.ac.ir
Web page address
http://nm.sbmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahsa Moslem
Position
Master student of pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti school of nursing and midwifery,in front of Shahid Rajaei hospital,Valiasr street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5363
Email
sbnmf@sbmu.ac.ir
Web page address
http://nm.sbmu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahsa Moslem
Position
Master student of pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti school of nursing and midwifery,in front of Shahid Rajaei hospital,Valiasr street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5363
Email
sbnmf@sbmu.ac.ir
Web page address
http://nm.sbmu.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Questionnaire information and only part of the main outcome information
When the data will become available and for how long
six months
To whom data/document is available
Nursing students and nurses
Under which criteria data/document could be used
Use in related research and similar to research title
From where data/document is obtainable
Contact with Mahsa Moslem via email: mahsa.moslem20n@gmail.com
What processes are involved for a request to access data/document
Data will be available up to ten days after receiving the email.