Effectiveness of Mindfulness Based Stress Reduction (MBSR) on Burden of Care in the Caregivers of hospitalized patients in Ebne Sina Hospital
Design
This study is a randomized clinical trial.The participants are selected from among the main caregivers of the hospitalized patients of EbneSina Hospital based on inclusion and exclusion criteria, and are placed in two intervention and control groups (n=19 in each group).
Settings and conduct
The participants are selected from among the main caregivers of the hospitalized patients of EbneSina Hospital based on inclusion and exclusion criteria, and are placed in the intervention and control groups (n= 19 in each group). Data is collected via individual information form of the patient and the caregiver, the mental burden questionnaire, and the depression, anxiety and stress questionnaire, 21 questions version (DASS21) before and after the intervention. 8 weekly sessions of MBSR will be conducted for the intervention group, and no intervention for the control group. Finally, the data will be analyzed by SPSS software.
Participants/Inclusion and exclusion criteria
Participants: from among the main caregivers of patients admitted to EbneSina Hospital.
Inclusion criteria: willingness to participate in the research; not having a substance use disorder, a major psychiatric disorder such as psychosis, and concurrent psychological treatments; minimum high school education.
Exclusion criteria: willingness to leave whenever the subjects want; absence of more than 50% in meetings.
Intervention groups
Intervention group: stress reduction sessions will be conducted based on mindfulness. The content of the 8 MBSR sessions will be determined. Control group: no intervention will be done; however the intervention will be done for them at the end of study due to ethical principles.
Main outcome variables
Care pressure; depression; anxiety; stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230807059072N1
Registration date:2024-01-22, 1402/11/02
Registration timing:registered_while_recruiting
Last update:2024-01-22, 1402/11/02
Update count:0
Registration date
2024-01-22, 1402/11/02
Registrant information
Name
Zahra Sadat sangsefidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2701
Email address
sangsefidiz981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-21, 1402/09/30
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Mindfulness Based Stress Reduction (MBSR) on Burden of Care in the Caregivers of hospitalized patients in Ebne Sina Hospital
Public title
Effectiveness of Mindfulness Based Stress Reduction (MBSR) on Burden of Care in the Caregivers of hospitalized patients in Ebne Sina Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the research
Not having a substance use disorder and not having a major psychiatric disorder such as psychosis
Not receiving concurrent psychological treatments
Minimum high school education
Exclusion criteria:
Willingness to leave whenever group members
Absence of more than 50% of group meetings
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Random permuted blocks method is used for random allocation. In this method, 9 blocks of 4 will be randomly selected from the combination of letters A and B. These blocks are AABB, ABBA, BBAA, BAAB, ABAB, BABA. We will also have a block of 2 in the form of AB or BA. The selection of blocks will be based on the table of random numbers and the preparation of blocks by someone outside the research team. The prepared blocks will be written on separate sheets and placed in sealed envelopes and will be provided to the researcher at the time of sampling. Allocation of letters A and B to the intervention and control groups will also be done randomly before the randomization by someone outside the research team so that being aware of the randomization process does not distort the selection.
To generate the random allocation sequence, the random table and the method mentioned above are used.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, blinding was done for the participants of both intervention and control groups. In addition, the person in charge of data collection, who is responsible for completing the CRFs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2023-07-21, 1402/04/30
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.174
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
by DASS 21
2
Description
Depression
Timepoint
Before and after intervention
Method of measurement
by DASS 21
3
Description
Stress
Timepoint
Before and after intervention
Method of measurement
by DASS 21
4
Description
Burden of Care
Timepoint
Before and after intervention
Method of measurement
by Zariet care pressure questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Formation of the group. Introduction and familiarization and explanation of the concept of automatic guidance. Introduction of the program and a brief description of the eight sessions to familiarize the group members with each other and advice on setting the goals and rules of the group. Familiarity with the educational concepts of stress reduction based on mindfulness and the need for mindfulness training. Explanation about automatic guidance. and meditating on eating raisins and then meditating on checking the body and conscious breathing for thirty minutes.
Category
Treatment - Other
2
Description
Control group: There is no training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
EbneSina hospital
Full name of responsible person
Dr Farshad Shaybani
Street address
Mashhad . haraami ST.next to the vehicle of qods razaviprovinceEbneSina hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3700 2201
Email
zahra_sangsefidy@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Farshad Sheybani
Street address
vakil abad.bahonar avenue
City
mashhad
Province
Razavi Khorasan
Postal code
9137913131
Phone
+98 51 3800 2200
Email
Sheibanifr@mums.ac.ir
Grant name
mashhad university of medical sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Sangsefidy
Position
Psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sina Hospital, next to Astan Quds Razavi, At the end of Har Ameli St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3700 2201
Email
zahra_sangsefidy@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Sangsefidy
Position
Psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sina Hospital, next to Astan Quds Razavi, At the end of Har Ameli St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3700 2201
Email
zahra_sangsefidy@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Sangsefidy
Position
Psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sina Hospital, next to Astan Quds Razavi, At the end of Har Ameli St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3700 2201
Email
zahra_sangsefidy@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
We did not have permission to publish data of participants.
Study Protocol
Yes - There is 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
Not applicable
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
We did not have permission to publish data of participants.
When the data will become available and for how long
We did not have permission to publish data of participants.
To whom data/document is available
We did not have permission to publish data of participants.
Under which criteria data/document could be used
We did not have permission to publish data of participants.
From where data/document is obtainable
We did not have permission to publish data of participants.
What processes are involved for a request to access data/document
We did not have permission to publish data of participants.