Protocol summary

Study aim
Determining the Effect of Acceptance and Commitment Therapy on Caregiver Burden in Mothers of Children with a Chronic Disease.
Design
This clinical trial has intervention and control groups, which are sampled using the available sampling method. The sample size is 60 people. Randomization of samples is done in a simple randomization method by tossing a coin.
Settings and conduct
the researcher will refer to the research environment and will identify and select the eligible samples, using the available sampling method. Then simple randomization will be done by the coin toss method and the samples will be directed to two intervention and control groups. after obtaining informed consent from the samples in both groups, The ACT program will be implemented by the researcher for the intervention group.
Participants/Inclusion and exclusion criteria
Including criteria:Not having a history of treatment similar to ACT, not having a physical or mental illness, being over 18 years of age, being able to communicate in Farsi, being literate, not being an immigrant, not being the head of a household or a widow, having had a child with a chronic disease for a year, having access to the Internet and a smartphone, child age 1-8 Excluding criteria:Reluctance to continue the intervention,absence of more than 2 sessions
Intervention groups
Interventions are prepared by the researcher and uploaded on a website belonging to the research. The intervention sessions are held in the form of one face-to-face session and 6 weekly virtual sessions. Fixing their problems and also giving them the motivation to continue the intervention is done using available social media.
Main outcome variables
mother' care burden

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240213061000N1
Registration date: 2024-05-10, 1403/02/21
Registration timing: registered_while_recruiting

Last update: 2024-05-10, 1403/02/21
Update count: 0
Registration date
2024-05-10, 1403/02/21
Registrant information
Name
Marziyeh Mirzalou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3331 0813
Email address
mz.mirzalou@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-05, 1402/12/15
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Acceptance and Commitment Therapy on Caregiver Burden in Mothers of Children with a Chronic Disease
Public title
The effect of Acceptance and Commitment Therapy on Caregiver Burden
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Participants who do not have a history of receiving treatment similar to ACT. Participants who do not have a chronic physical illness. Participants who do not suffer from acute mental illness. Participants who be older than 18. Participants who have the ability to communicate in Farsi. Participants who Be literate in reading and writing. Participants who have willingness to participate in research. Participants who not be part of the immigrant population. Participants who not be householder, divorced or widower. Participants who have passed one year since their child had a chronic disease. The age range of their child should be from infancy to adolescence (1 to 18 years old). Their child should have a physical chronic condition such as cardiovascular, gastrointestinal, endocrine,... chronic conditions. Participants who have access to the Internet. Participants who have access to a mobile phone, tablet, or computer.
Exclusion criteria:
Participants who do not want to continue participating in the research. Participants who have more than two absences in the intervention sessions (due to reasons such as the mother suffering from an acute illness, travel, deterioration of the child's illness, death of the child, etc.).
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be done by the coin toss method and the samples will be directed to two intervention and control groups.
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 Shahid Beheshti University of Medical Sciences
Street address
No. 18, Jahanian Alley, 17Shahrivar Ave, Shohada Sq, Tehran
City
Tehran
Province
Tehran
Postal code
۱۷۱۸۶۴۴۳۷۱
Approval date
2023-08-01, 1402/05/10
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.076

Health conditions studied

1

Description of health condition studied
Chronic disease
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus

2

Description of health condition studied
Chronic disease
ICD-10 code
C71
ICD-10 code description
Malignant neoplasm of brain

3

Description of health condition studied
Chronic disease
ICD-10 code
C72
ICD-10 code description
Malignant neoplasm of spinal cord, cranial nerves and other parts of central nervous system

4

Description of health condition studied
Chronic disease
ICD-10 code
D56
ICD-10 code description
Thalassemia

5

Description of health condition studied
Chronic disease
ICD-10 code
D57
ICD-10 code description
Sickle-cell disorders

6

Description of health condition studied
Chronic disease
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis

7

Description of health condition studied
Chronic disease
ICD-10 code
C91
ICD-10 code description
Lymphoid leukemia

8

Description of health condition studied
Chronic disease
ICD-10 code
G80
ICD-10 code description
Cerebral palsy

9

Description of health condition studied
Chronic disease
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures

10

Description of health condition studied
Chronic disease
ICD-10 code
I50
ICD-10 code description
Heart failure

11

Description of health condition studied
Chronic disease
ICD-10 code
I42
ICD-10 code description
Cardiomyopathy

12

Description of health condition studied
Chronic disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)

13

Description of health condition studied
Chronic disease
ICD-10 code
K74
ICD-10 code description
Fibrosis and cirrhosis of liver

Primary outcomes

1

Description
Care Burden in mothers of children with chronic diseases
Timepoint
Evaluating care burden of mothers before beginning of the intervention, 21 days after the beginning and 45 days after the beginning of the intervention
Method of measurement
Care Burden Scale (CBS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: ACT intervention will be held in the form of one face-to-face session and 6 virtual sessions weekly, and the minimum time for each session is 45 minutes. Virtual sessions in the form of video, audio and text trainings are prepared according to the needs of each session and will be uploaded every week at the appointed time on the website related to the research and displayed on the user panel of each example. Using the virtual networks available for each example, as well as the online chat and private message capabilities on the site, the researcher will do the necessary follow-up in relation to sending the exercises and fixing their problems, as well as giving motivation to continue the intervention. The sessions in this intervention are based on the six main axes of the act, including "acceptance", "cognitive isolation", "awareness of the present moment", "self-esteem", "values" and "committed action".
Category
Other

2

Description
Control group: will 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
Mahrokh Goldoost
Street address
No 62, Dr. gharib Ave, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6688 2683
Email
cmcpr@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Manijeh Nourian
Street address
Vali-e-Asr Ave
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
sbmuf@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
Fatemeh Ebrahimpour
Position
Consultant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vali-e-Asr Ave
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
fa2892@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Ebrahimpour
Position
Consultant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vali-e-Asr Ave
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
fa2892@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Marziyeh Mirzalou
Position
Master of nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
17 Shahrivar st. Jahanian alley
City
Tehran
Province
Tehran
Postal code
1718644371
Phone
+98 21 3331 0813
Fax
Email
mz.mirzalou@sbmu.ac.ir

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
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