Determining the effect of virtual self-compassion training on chronic sorrow and coping strategies in mothers of children with cerebral palsy
Design
A clinical trial that has no precedent in terms of randomization, single-group and blinded, which is conducted on 137 mothers. o
Settings and conduct
Virtual training of self-compassion in the form of several audio and video files in simple language, through Bale software, on mothers of children with cerebral palsy. Research field: Imam Reza Clinic. File content:
1. Knowing and explaining the rules and aims of meetings and the definition of self-compassion
2. Knowing the components of self-compassion, the origin and importance of self-compassion
3. Understanding the approach and characteristics of self-compassion
4. Knowing the compassion skills
5. Compassionate mind training
6. Development of compassion characteristics
7. Development of compassionate skills
8. The main techniques of training the compassionate mind: compassionate imagery, soothing breathing rhythm, mindfulness, compassionate letter writing
Participants/Inclusion and exclusion criteria
1.Desire to participate in the study
2. Having only one child with cerebral palsy
3.Not having a history of physical and mental illness according to the doctor's diagnosis
4.Having a smartphone to install Bale software
5.Performing maternal duties as a caregiver
6.The health of other family members
7.Confirmation of cerebral palsy in a child
Intervention groups
137 eligible mothers of children with cerebral palsy referred to Imam Reza clinic who received virtual self-compassion training through Bale software in the form of audio-video files.
Main outcome variables
1.Chronic Sorrow score in the Kendall Chronic Sorrow questionnaire
2. Coping Strategies score in the Folkman and Lazarus coping strategies questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240106060625N1
Registration date:2024-02-12, 1402/11/23
Registration timing:registered_while_recruiting
Last update:2024-02-12, 1402/11/23
Update count:0
Registration date
2024-02-12, 1402/11/23
Registrant information
Name
Fateme Tamadon
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 9537
Email address
fatmhtmdn95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-04, 1402/11/15
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual self-compassion training on chronic sorrow and coping strategies in mothers of children with cerebral palsy
Public title
The effect of virtual self-compassion training on chronic sorrow and coping strategies
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Desire to participate in the study
Performing maternal duties as a caregiver
Having a smart phone and installing Bale software to receive educational audio files
Not having a history of physical and mental illness according to the doctor's diagnosis
Having only one child with cerebral palsy
The health of other family members
Confirmation of cerebral palsy in a child by a pediatric neurologist
Exclusion criteria:
Undesire to participate in the study
Any case does not receive feedback regarding the use of audio files
Separation from husband
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
137
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2023-12-23, 1402/10/02
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.119
Health conditions studied
1
Description of health condition studied
Cerebral palsy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Chronic Sorrow in mothers of children with cerebral palsy
Timepoint
Before, immediately and one month after self-compassion training
Method of measurement
Kendall Chronic Sorrow Questionnaire
2
Description
Coping strategies in mothers of children with cerebral palsy questionnaire
Timepoint
Before, immediately and one month after self-compassion training
Method of measurement
Folkman and Lazarus Coping Strategies Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In this study after approving the proposal, obtaining the national code of ethics, the clinical trial code, permission from the University of Medical Sciences and receiving the letter of introduction from Imam Reza Clinic (AS), the researcher will refer to this clinic. The research samples will be 137 mothers of children with cerebral palsy referring to Imam Reza (AS) clinic who will be included in the study randomly. The researcher will give reassurance to the mothers after introducing herself and explaining the objectives of the project and confidentiality of information. After obtaining informed consent from the mothers, the Chronic Sorrow and Coping Strategies questionnaires will be completed with the cooperation of the research assistant. After repeated reviews of the research environment due to the large number of samples, the lack of a conference room for face-to-face training of mothers in the clinic and the impossibility of simultaneous attendance of mothers in training sessions, according to the professors and the research team, self-compassion virtual training in the form of several audio and video files Simple language will be available to mothers of children with cerebral palsy through Bale software during eight sessions in about one month. This research is a single intervention group and the samples are measured before and after the intervention. Self-compassion virtual training consist: Knowing and explaining the rules and aims of meetings and the definition of self-compassion, Knowing the components of self-compassion, the origin and importance of self-compassion, Understanding the approach and characteristics of self-compassion, Knowing the compassion skills, Compassionate mind training, Development of compassion characteristics, Development of compassionate skills, The main techniques of training the compassionate mind: compassionate imagery, soothing breathing rhythm, mindfulness, compassionate letter writing. Immediately after receiving the complete audio and video files and a month later, the relevant questionnaires will be completed again. Finally the data will be recorded and analyzed by SPSS version 22 software.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza (AS) clinic of Shiraz
Full name of responsible person
Dr Mani Ramzi
Street address
Namazi Sq, Imam Reza Clinic
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Email
ramzim@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hashem Hashempur
Street address
Zand St., Central Building of Shiraz University of Medical Sciences, 7th floor, Research and Technology Deputy
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Tamadon
Position
Master of Pediatric Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Namazi Square, Fatemeh College of Nursing and Midwifery of Hazrat Fatemeh
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
0098 71 36474254-8
Email
fateme.tamadon@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
DR Mitra Soltanian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazi Square, Fatemeh College of Nursing and Midwiferyry
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
mitsoltan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Tamadon
Position
Master of Pediatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Namazi Square, Fatemeh College of Nursing and Midwifery
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
0098 71 36474254-8
Email
fateme.tamadon@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available