Effectiveness of mindfulness-based stress intervention on the experience of grief, feeling of social isolation, and cognitive-emotional regulation of martyrs' wives
Effectiveness of mindfulness-based stress intervention on the experience of grief, feeling of social isolation, and cognitive-emotional regulation of martyrs' wives
Design
A clinical trial including an experimental group and a control group, randomized in a simple way, with pre-test and post-test on 40 wives of martyrs.
Settings and conduct
The experimental group will undergo an 8-week course of stress intervention based on mindfulness, meditation and yoga relaxation techniques (stretching exercises and mindful movement exercises), but the control group will not receive any intervention. Both the experimental group and the control group are measured twice (pre-test and post-test) separately. The performance will be performed among the wives of the martyrs of Zahedan city in 8 sessions of 90 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Commitment to continuous participation in training sessions, the same conditions for the spouses of the martyrs, the same conditions for the intervention group and the control group
Intervention groups
The design of training sessions will be conducted in 8 sessions of 90 minutes using the method of stress intervention based on mindfulness according to the effects of bereavement experience. Training in the control group is done by lecture method. Finally, after the completion of the course, the questionnaires on the experience of bereavement, feeling of social isolation, and cognitive emotional regulation will be administered as a post-test among the subjects of the two test groups. will be placed.
Main outcome variables
Bereavement experience, feeling of social isolation, emotional cognitive regulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231231060577N1
Registration date:2024-02-18, 1402/11/29
Registration timing:registered_while_recruiting
Last update:2024-02-18, 1402/11/29
Update count:0
Registration date
2024-02-18, 1402/11/29
Registrant information
Name
Zeynab Keykha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 2344 1488
Email address
zkhikha@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of mindfulness-based stress intervention on the experience of grief, feeling of social isolation, and cognitive-emotional regulation of martyrs' wives
Public title
Effectiveness of mindfulness-based stress intervention on the experience of grief, feeling of social isolation, and cognitive-emotional regulation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Martyr's wife.
Commitment to attend regular meetings.
The same conditions of the wives of martyrs in the intervention group.
Exclusion criteria:
Age
No age limit
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
In this study, in order to select a sample, 40 spouses of martyrs of Zahedan city who are eligible based on the research entry criteria and who volunteer to participate in the research are selected. Then people are divided into an experimental group (20 people) and a control group (20 people) by simple randomization and using a table of random numbers.
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 in Islamic Azad University Research
Street address
Islamic Azad University Complex, Zahedan Branch, University Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743545
Approval date
2023-12-31, 1402/10/10
Ethics committee reference number
IR.IAU.ZAH.REC.1402.092
Health conditions studied
1
Description of health condition studied
The experience of grief
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Feeling of social isolation
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Emotional cognitive regulation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The Experience of Grief
Timepoint
Before the Beginning of the Educational Intervention and 90, 60 Days After the Educational Intervention
Method of measurement
Barrett and Scott Bereavement Experience Questionnaire
2
Description
Feeling of Social Isolation
Timepoint
Before the Beginning of the Educational Intervention and 90, 60 Days After the Educational Interventio
Method of measurement
Chalapi and Amirkafi Social Isolation Questionnaire
3
Description
Cognitive-Emotional Discipline
Timepoint
Before the Beginning of the Educational Intervention and 90, 60 Days After the Educational Interventio
Method of measurement
Granifsky and Kraij Standard Cognitive-Emotional Ordering Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: including techniques such as; Deep breathing, scanning and observing the body in a mindful way, meditation and yoga relaxation techniques (stretching exercises and mindful movement exercises) will be held.
Category
N/A
2
Description
Control group: no educational intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Administration of Shahid Foundation of Zahedan city
Full name of responsible person
Zainab Kikha
Street address
Khorramshahr St
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817819135
Phone
+98 915 140 6028
Email
zkhikha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad university
Full name of responsible person
Kambiz Narmashiri
Street address
Islamic Azad University Complex, Zahedan Branch, University Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743545
Phone
+98 54 3344 3600
Email
University@iauzah.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad university
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
Islamic Azad University
Full name of responsible person
Ali Arab
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Sistan and Baluchistan, University Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98155987
Phone
+98 54 3344 6251
Email
Aliarab@edpsy.usb.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad university
Full name of responsible person
Zainab Kikha
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Complex, Zahedan Branch, University Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817744645
Phone
054334814
Email
zkhikha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad university
Full name of responsible person
Ali Arab
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Sistan and Baluchistan, University Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98155987
Phone
+98 54 3344 6251
Email
Aliarab@edpsy.usb.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Information on the main outcomes is shared.
When the data will become available and for how long
Access starts from 1403
To whom data/document is available
Supervisor, Advisor and Referees
Under which criteria data/document could be used
Checking the accuracy of the statistical data provided
From where data/document is obtainable
Contact the main researcher through the university's research unit, email address:
zkhikh@gmail.com Contact number: 09151406028
What processes are involved for a request to access data/document
Reviewing the submitted research report, requesting to send data files via email address with the researcher's contact number. Sending data files by the researcher via email, research assistant system or internal social messengers