Comparison of the Effect of Narrative Therapy with Emotional Disclosure on Emotional Regulation and Unpleasant Emotions in Mothers of Children with Leukemia
Determining the effect of narrative therapy and emotional disclosure on emotion regulation and unpleasant emotions in the mothers of children with leukemia.
Design
A clinical trial with a control group, Two intervention groups, Parallel-group trial with the concealed data collection and data analysis, Block randomize allocation, Enrolled between September 2018 and January 2018.
Settings and conduct
The study settings are Bahrami hospital and Medical center of children affiliated to Tehran University of Medical Sciences (TUMS).After receiving the approval of the ethical committee , the sampling will be done by a convenient method according to inclusion and exclusion criteria . After that, the selected samples will be randomly allocated by a blocking method into 3 groups. At group 1, group narrative therapy will be held according to White and Epston model and in 10 sessions 2-3 times weekly. At group 2, emotional disclosure, the 4 weekly sessions will be held according to the individual-based approach. Control group do not receive any intervention. The data collection and analysis will be concealed by involving a non-member of the research team.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a minimum level of literacy, Living child with mother, Not having single-parenting, Child age under 18 years old, Disease diagnosed period more than 1 month
Exclusion criteria: Participating in the same program and happening a stressful event during the research period.
Intervention groups
The group intervention 1 is a group narrative therapy adapted from the White and Epston program. The program will be held in 10 one-hour sessions two or three times a week.
The intervention group 2, emotional self-disclosure will be held in 4 two-hour therapy sessions weekly with an individual-based and homework approach.
Main outcome variables
Emotion regulation; Unpleasant emotions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151003024312N5
Registration date:2019-04-17, 1398/01/28
Registration timing:retrospective
Last update:2019-04-17, 1398/01/28
Update count:0
Registration date
2019-04-17, 1398/01/28
Registrant information
Name
Fataneh Ghadirian Baharanchi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4311
Email address
ghadirian.fataneh@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
2018-08-23, 1397/06/01
Actual recruitment end date
2018-12-22, 1397/10/01
Trial completion date
2019-01-15, 1397/10/25
Scientific title
Comparison of the Effect of Narrative Therapy with Emotional Disclosure on Emotional Regulation and Unpleasant Emotions in Mothers of Children with Leukemia
Public title
Effect of Narrative Therapy and Emotional Disclosure on Emotional Regulation and Unpleasant Emotions
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The mother has a minimum literacy level (reading and writing)
The child lives with the mother and she/he is not a single parent.
The maximum limit of the child age is18 years old.
The child is not suffering from chronic or congenital leukemia.
At least one month has been passed after the leukemia is diagnosed.
The mother does not have any chronic physical or mental condition.
Exclusion criteria:
The mother participates in the same educational program.
Stressful event happened during the research period.
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The selected mothers will be allocated into three groups by block randomization method (group 1: Group narrative therapy intervention, Group 2: Individual-based emotional disclosure intervention, and Group 3: Control). Block allocations conceal by non-fixed block randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data collectors at before and after intervention are non-members of the research team. They are the staff of the research setting who are trained. The data analysis will be done by a non-involved member at random allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of School of Nursing Midwifery & Rehabilitation ,Tehran University of Medical Scien
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences. Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-07-02, 1397/04/11
Ethics committee reference number
IR.TUMS.FNM.REC.1397.031
Health conditions studied
1
Description of health condition studied
Unpleasant Emotions
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The Cognitive regulation scores in Garnofsky questionnaire
Timepoint
Before intervention and two weeks after intervention
Method of measurement
Garnofsky Cognitive regulation questionnaire
2
Description
Unpleasant emotions (Anxiety, depression, and stress) scores on the DASS-21 questionnaire
Timepoint
Before intervention and two weeks after intervention
Method of measurement
The Depression Anxiety, Stress Scales—21/ (DASS‐21) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The intervention in the narrative therapy group will be held at 10 group-based sessions adapted from the White and Epston program. The sessions will be one- hour two-three times a week. The therapeutic sessions will be according to the personal history narrations and the discussions around the unpleasant emotions management.
Category
Rehabilitation
2
Description
Intervention group 2: The intervention in the self-disclosure group will be designed in Self-disclose interactive sessions will also be conducted for 4 weekly sessions for 1 month, individually and with a homework approach. Therapeutic communications will focus on the treatment and management of written unpleasant emotions in personal histories of mothers from their child disease.
Category
Rehabilitation
3
Description
Control group: Mothers of children in this group do not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Fّataneh .Ghadirian
Street address
Tehran Province, Dr. Mohammad Gharib
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2368
Email
f-ghadirianb@tums.ac.ir
2
Recruitment center
Name of recruitment center
Bahrami Children Hospital
Full name of responsible person
Fّataneh .Ghadirian
Street address
Tehran Province, Shahid Kiani st
City
Tehran
Province
Tehran
Postal code
1641744991
Phone
+98 21 7301 3000
Email
f-ghadirianb@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fataneh.Ghadirian
Street address
Tohid Sq.,Tehran University Of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4113
Email
ghadirian.fataneh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fataneh Ghadirian
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat Ave., Tohid Sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4113
Email
f-ghadirianb@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fataneh Ghadirian
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat Ave., Tohid Sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4113
Email
f-ghadirianb@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fataneh Ghadirian
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat Ave., Tohid Sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4113
Email
f-ghadirianb@tums.ac.ir
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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Title and more details about the data/document
There is no more information
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
This only available for people working in academic institutions
Under which criteria data/document could be used
Only observation and use of descriptive statistics
From where data/document is obtainable
Contact person: Dr. Fataneh Ghadirian E-mail Address: f-ghadirianb@tums.ac.ir
What processes are involved for a request to access data/document
Sending email from an academic email Maximum one month needed to follow through this process