Determining the effect of mindfulness-based stress reduction program on somatization and obsessive beliefs of nurses
Design
The clinical trial had a control group with randomized samples by lottery and not blinded.
Settings and conduct
Mindfulness-based stress reduction program for 2 sessions of 1.5 hours every week on Wednesdays is held online by the project manager who has obtained the certificate of this course with Adob Conect software. Online sessions in the form of lectures, questions and answers, group discussions And the techniques are practiced. In order to continue communicating with the participants, their phone number and home address will be obtained, and by forming educational groups in Telegram and WhatsApp, communication will be maintained with them.
Participants/Inclusion and exclusion criteria
Admission:
Age over 22 years and under 45 years
At least 1 year of work experience in the emergency
Have at least a bachelor's degree in nursing
commitment to complete meetings
No entry:
Existence of a severe mental illness
Use of psychiatric drugs
Simultaneous receiving of any other type of psychotherapy and recent occurrence (in the last 6 months)
Participate in any yoga activities and meditation classes now
Absence from attending two consecutive sessions of intervention and occurrence of a stressful incident during the intervention
Intervention groups
The intervention group was selected by available methods Then they were taught mindfulness training sessions for 8 sessions of 2 hours for 1 day a week. Mindfulness is a non-invasive and non-pharmacological method that increases a person's attention, reduces physiological reactions and regulates a person's emotions.
The control group does not receive training during this period.
Main outcome variables
Obsessive beliefs , Somatization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201030049196N1
Registration date:2021-06-19, 1400/03/29
Registration timing:registered_while_recruiting
Last update:2021-06-19, 1400/03/29
Update count:0
Registration date
2021-06-19, 1400/03/29
Registrant information
Name
Razieh Dehvan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 3333
Email address
raziehdehvan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-14, 1400/03/24
Expected recruitment end date
2021-07-16, 1400/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness-based stress reduction (MBSR) program Training on Somatization Disorder and Obsessive Beliefs of Nurses
Public title
The effect of mindfulness-based stress reduction (MBSR) program Training on Somatization Disorder and Obsessive Beliefs of Nurses
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 22 years and under 45
At least 1 year of work experience in the emergency room
Have at least a bachelor's degree in nursing
Commitment to completing meetings
Exclusion criteria:
Existence of a severe mental illness
Use of psychiatric drugs
Simultaneous receiving of any other type of psychotherapy and the recent occurrence (in the last 6 months) of an important stressful event in life (such as the death of a loved one)
Participate in any yoga activities and meditation classes now
Absence from two consecutive sessions of intervention and the occurrence of a stressful event during the intervention
Age
From 22 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Using lotteries among the samples participating in the study
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 the School of Nursing, Midwifery and Rehabilitation, Tehran University of Medica
Street address
No. 246, East Imam Khomeini St, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6194934887
Approval date
2020-06-01, 1399/03/12
Ethics committee reference number
IR.TUMS.FNM.REC.1399.037
Health conditions studied
1
Description of health condition studied
The obsessive beliefs
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
2
Description of health condition studied
Somatization disorder
ICD-10 code
F45.0
ICD-10 code description
Somatization disorder
Primary outcomes
1
Description
Somatization
Timepoint
At the beginning of the study and one month after the intervention
Method of measurement
Questionnaire PHQ15
2
Description
The obsessive beliefs
Timepoint
At the beginning of the study and one month after the intervention
Method of measurement
Questionnaire OBQ_44
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They were selected by the available method and in addition to receiving routine care, they receive mindfulness exercises in 8 sessions for 2 hours one day a week. Mindfulness is a non-invasive and non-pharmacological method that increases a person's attention, decreases Physiological reactions and regulation of emotions
Category
Lifestyle
2
Description
Control group: Nurses who do not receive any mindfulness training during this course.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals under the supervision of Ahwaz University of Medical Sciences
Full name of responsible person
Razieh Dehvan
Street address
School of Nursing and Midwifery, Nosrat Sharghi, Tohid Square ,Tehran
City
Ahvaz
Province
Khouzestan
Postal code
6194934887
Phone
+98 61 3228 4555
Email
raziehdehvan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Tarane Taghavi larijani
Street address
School of Nursing and Midwifery, Nosrat Sharghi st, Tohid Square ,Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 4411
Email
Higher_education@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Razieh Dehvan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 246, East Imam Khomeini St, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
1419733171
Phone
+98 61 3228 4555
Email
raziehdehvan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Razieh Dehvan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 246. Eastern Imam Khomeini St
City
Ahvaz
Province
Khouzestan
Postal code
6194934887
Phone
+98 61 3228 4445
Email
raziehdehvan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Razieh Dehvan
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 246, East Imam Khomeini St, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6194934887
Phone
+98 916 799 2769
Email
raziehdehvan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Additional information will be published with the permission of the project manager and the university
When the data will become available and for how long
Additional information will be published with the permission of the project manager and the university
To whom data/document is available
Additional information will be published with the permission of the project manager and the university
Under which criteria data/document could be used
Additional information will be published with the permission of the project manager and the university
From where data/document is obtainable
Additional information will be published with the permission of the project manager and the university
What processes are involved for a request to access data/document
Additional information will be published with the permission of the project manager and the university