Effect of Program based on Mindfulness Self compassion on Psychological Distress and quality of life among the family caregivers of patients with chronic obstructive pulmonary disease
Determining the impact of the mindfulness-based compassion program on psychological distress and quality of life of family caregivers of patients with chronic obstructive pulmonary disease.
Design
This study is a two-group clinical trial study with intervention and control groups that will investigate the effect of a program based on mindfulness as an independent variable on psychological .....
Settings and conduct
After the approval of the research by the ethics committee of Isfahan University of Medical Sciences, the researcher will refer to Jame Tashir Clinic by presenting a written letter of introduction from the Faculty of Nursing and Midwifery of IUMS and obtaining permission from the authorities of Khurshid Hospital.
Participants/Inclusion and exclusion criteria
Entry criteria for family caregivers:
Declaring willingness to participate in the study by completing the informed consent form
Age group 18-60 years
Having no history of suffering from cognitive disorders (such as dementia) and mental disorders (severe anxiety and depression) and severe physical diseases (arthritis, heart disease, nervous, etc.) in the caregivers, according to the opinion of the center's doctor
Having minimum reading and writing literacy
Exit criteria:
Unwillingness of caregivers to continue cooperation
The withdrawal of research units from the study for any reason, such as the death of the patient and the caregiver under their support, relocation, etc.
Absence of more than 2 sessions in the program
Entrusting the care of the patient to other people
Responsibility for caring for another family member with a chronic illness
Intervention groups
After explaining the objectives and obtaining a written informed consent and assuring her of the confidentiality of the information contained in the questionnaire, she will enter the study.
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200411047029N3
Registration date:2024-01-28, 1402/11/08
Registration timing:registered_while_recruiting
Last update:2024-01-28, 1402/11/08
Update count:0
Registration date
2024-01-28, 1402/11/08
Registrant information
Name
Ramin Sami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2892
Email address
r.sami@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Program based on Mindfulness Self compassion on Psychological Distress and quality of life among the family caregivers of patients with chronic obstructive pulmonary disease
Public title
: Investigating the impact of the mindfulness-based compassion program on psychological distress and quality of life of family caregivers of patients with chronic obstructive pulmonary disease.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Declaring willingness to participate in the study by completing the informed consent form•
Having no history of suffering from cognitive disorders (such as dementia) and mental disorders (severe anxiety and depression) and severe physical diseases (arthritis, heart disease, nervous, etc.) in the caregivers, according to the opinion of the center's doctor
Having minimum reading and writing literacy
The main responsibility of caring for the patient rests with the caregiver.
More than 6 months of patient care experience. and live with the patient
Exclusion criteria:
Unwillingness of caregivers to continue cooperation
The withdrawal of research units from the study for any reason, such as the death of the patient and the caregiver under their support, relocation, etc
Absence of more than 2 sessions in the program
Entrusting the care of the patient to other people
Responsibility for caring for another family member with a chronic illness
Participation in similar courses
The occurrence of exciting events (events with great bitterness or happiness) for family caregivers
Age
From 18 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
They will be randomly assigned by the software in intervention and control groups. The research units will be randomly allocated in two intervention and control groups using Minimizer software.
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 isfahan University of Medical Sciences
Street address
hezarjarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2024-01-09, 1402/10/19
Ethics committee reference number
IR.ARI.MUI.REC.1402.260
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description
Quality of Life
Timepoint
6 months
Method of measurement
The 12-question quality of life questionnaire is a shortened form of the 36-question quality of life questionnaire designed in 1996 by War-Kasinski and Keller.
Secondary outcomes
1
Description
Psychological distress
Timepoint
6 months
Method of measurement
Kessler's Psychological Distress Questionnaire, which is a special questionnaire for identifying mental disorders in the general population, which Kessler et al. compiled in 2003 in two forms of 10 questions and 6 questions, and has three components: educational presence, social presence, and cognitive presence.
Intervention groups
1
Description
Intervention group:Caregivers of patients in the intervention group are examined through the intervention of implementing a program based on conscious mindfulness (independent variable). After the completion of the intervention, the questionnaires are completed by two groups and the collected data are used by SPSS No. 20 software and appropriate tests such as independent t, paired t and covariance analysis if needed.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
khorshid medical educational research complex
Full name of responsible person
Mohsen Forghani
Street address
Ostandari
City
Isfahan
Province
Isfehan
Postal code
۸۱۴۵۸۳۱۴۵۱
Phone
+98 31 3224 5681
Email
nour@mui.ac.ir
Web page address
http://nour.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
کمال حیدری
Street address
hezarjarib
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
khabarnameh@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
1
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
Esfahan University of Medical Sciences
Full name of responsible person
ramin sami
Position
دانشیار
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Hezarjarib
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668
Email
r.sami@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
ramiin sami
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
hezarjarib
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 913 322 1022
Email
r.sami@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
ramin sami
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
hezarjarib
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 913 322 1022
Email
r.sami@med.mui.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