Determining the effect of mindfulness based on stress reduction on emotional regulation and mental health of pre-hospital emergency staff of Kashan University of Medical Sciences 2021
Design
A randomized, parallel group, controlled trial
Settings and conduct
The study was designed to "The effect of mindfulness based on stress reduction on mental health and emotional regulation of pre-hospital emergency staff of Kashan University of Medical Sciences"
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Satisfaction to participate in the study
2. Do not have a known physical illness (self-report)
3. Do not have a known mental illness (self-report)
4- Not receiving mood-regulating drugs in the last 3 months
5. Not participating in similar mindfulness courses in the last 6 months
6- Having an associate's or bachelor's degree in pre-hospital emergencies
7- Employed and having at least 6 months of work experience as a pre-hospital emergency
8- Obtaining a score of 22 and above from the general health questionnaire and at the beginning of the study
Exclusion criteria:
1- Withdrawal from continuing cooperation
2. Absence from more than 2 sessions of mindfulness sessions
3- Lack of access to samples in the stages of monitoring mental health status and emotion regulation
4. Start taking mood-regulating drugs
5. Participate in similar courses based on mindfulness during the study
Intervention groups
The intervention group receives 8 sessions of MBSR in each week. Each session is 60 minutes and the treatment sessions are based on the Kabat Zin protocol. The control group just received pamphlets on mental health according to the NANDA International Association.
Main outcome variables
mental health
emotional regulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130721014086N15
Registration date:2022-01-19, 1400/10/29
Registration timing:registered_while_recruiting
Last update:2022-01-19, 1400/10/29
Update count:0
Registration date
2022-01-19, 1400/10/29
Registrant information
Name
Mohammad Aghajani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 2001
Email address
aghajani_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of "Mindfulness-based stress reduction" on emotional regulation and mental health of pre-hospital emergency staff
Public title
The effect of "Mindfulness-based stress reduction" on emotional regulation and mental health of pre-hospital emergency staff
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Have an associate's or bachelor's degree in pre-hospital emergencies
Employed and having at least 6 months of work experience as a pre-hospital emergency
Exclusion criteria:
Withdrawal from continuing cooperation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are defined as block randomization in the form of 6 blocks using Sealed Envelope Ltd.2017 software available through the site www.sealedenvelope.com, with twelve blocks of 6 that are assigned to two 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 Kashan University of Medical Sciences
Street address
Ghotbe Ravadi, Kashan
City
Kashan
Province
Isfehan
Postal code
88715973474
Approval date
2022-01-03, 1400/10/13
Ethics committee reference number
IR.KAUMS.REC.1400.056
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
2
Description of health condition studied
Depression
ICD-10 code
F53.0
ICD-10 code description
Mild mental and behavioural disorders
Primary outcomes
1
Description
Mental health
Timepoint
Before study and 1 month later
Method of measurement
General Health Questionare
Secondary outcomes
1
Description
Emotional regulation
Timepoint
Before study and 1 month later
Method of measurement
Difficulties in Emotion Regulation Scale
Intervention groups
1
Description
Intervention group: Intervention group:The 8 weekly sessions followed the standard MBSR protocol as developed by Kabat-Zinn (1990). Each session was 60 min. The overall content of the sessions were:1)Introducing mindfulness 2)Sitting Meditation 3)Body Scan and walking meditation 4)yoga 5)Mindfulness of feelings and physical pain, meditation in every day of life 6)Self-reflection and self-management 7)Acceptance and changing 8)How can I take the best care of myself?
Category
Behavior
2
Description
Intervention group: Control group: patients receive usual treatments and educational pamphlets
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency Medical Center of Kashan University of Medical Sciences
Full name of responsible person
Sanaz Lotfi
Street address
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
88715973474
Phone
+98 31 5558 9021
Email
sanazlotfi6758@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9021
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
lectuerer
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Km 3 Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
aghajani1362@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Km 3 Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36115550021
Email
aghajani1362@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Km 3 Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36 1555 0021
Email
aghajani_m@kaums.ac.ir
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