Protocol summary

Study aim
Determining the Effect of mindfulness-based stress reduction counseling on perceived stress and emotion regulation of midwives working in Hospitals in Zanjan
Design
In this research, 60 midwives who received over-28 at cohen perceived stress questionnaire were enrolled in the study and randomly divided into intervention and control groups and assigned to each participant a code.
Settings and conduct
The research population includes all midwives working in the delivery wards of hospitals in Zanjan.By co-ordinating with the director of nursing services and the departments of maternity wards of Ayatollah Mousavi and Imam Hossein hospitals, they will be involved in the research.. Sampling is a census and allocation of individuals as a random block.Before the intervention, the researcher will insist on the satisfaction of the research samples to participate in the research and emphasize the confidentiality of information by introducing and explaining the subject of the research and its purpose.Intervention takes place in eight sessions of one and a half hours in the form of group counseling as a one-week session provided by the researcher.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: 1) Having a expert degree in midwifery and higher. 2) Gaining a score of 28 from Cohen's Perceived Stress Questionnaire. 3) Having one year of work experience in obstetrics and gynecology. 4) Written consent for participation in the study. 5) The desire to participate regularly in group meetings. 6) No Smoking and Drug Abuse 7) Accommodation in Zanjan City Exit criteria: 1) Unwillingness to continue study 2) Absence more than two sessions in counseling sessions 3) Flawed completion of the questionnaire (so that more than 20 percent of the questions remain unanswered). 4) Getting out of the study if you diagnose mental disorders in each the level
Intervention groups
Intervention takes place in eight sessions of one and a half hours in the form of group counseling as a one-week session provided by the researcher.Control group members will not receive any advice.
Main outcome variables
Reducing stress

General information

Reason for update
Acronym
MBSR
IRCT registration information
IRCT registration number: IRCT20160608028352N6
Registration date: 2018-01-08, 1396/10/18
Registration timing: registered_while_recruiting

Last update: 2018-01-08, 1396/10/18
Update count: 0
Registration date
2018-01-08, 1396/10/18
Registrant information
Name
Roghieh Kharaghani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8144
Email address
r.kharaghani@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness-based stress reduction counseling on perceived stress and emotion regulation of midwives
Public title
The effect of mindfulness-based stress reduction counseling on perceived stress and emotion regulation of midwives
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a expert degree in midwifery and higher Gaining a score of 28 from Cohen's Perceived Stress Questionnaire Having one year of work experience in obstetrics and gynecology. Female sex Interested in attending counseling sessions No smoking and drug abuse Accommodation in Zanjan city Not attending other counseling sessions in the last two months The lack of other stressful situations in life, such as the divorce or death of one of the loved ones
Exclusion criteria:
Getting out of the study if you diagnose mental disorders in each the level Unwillingness to participate in the study Completion of the incomplete questionnaire in such a way that more than 20% of the questions are unanswered
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The census sampling method includes midwives working in two hospitals, Ayatollah Mousavi and Imam Hossein, whose score in the perceived stress questionnaire above the cutting line is 28, and other features of the study entry. The subjects were selected by simple sampling method and assigned as random block in two groups of intervention and control
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
مرکز ثبت کارآزمایی بالینی ایران
Secondary trial Id
A-11-980-11
Registration date
2017-11-21, 1396/08/30

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
North Side Azadi Boulevard
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2017-12-13, 1396/09/22
Ethics committee reference number
ZUMS.REC.1396.237

Health conditions studied

1

Description of health condition studied
STRESS
ICD-10 code
F43.2
ICD-10 code description
Adjustment disorders

Primary outcomes

1

Description
Perceived Stress
Timepoint
Before intervention , after intervention, and three months after intervention
Method of measurement
Cohen Perceived Stress Questionnaire

Secondary outcomes

1

Description
Emotion regulation
Timepoint
Before intervention, after intervention, and three months after intervention
Method of measurement
Garretz and Roemer's Thrilling Setting Questionnaire

Intervention groups

1

Description
30 Control group and 30 control group intervention groups will not receive any counseling
Category
Behavior

2

Description
Intervention group: Individuals in the intervention group will be given eight sessions of one and a half hours of group counseling for the reduction of consciousness-minded stress, all of which will be provided by the researcher. The number of sessions was determined according to the studies that were conducted using a similar counseling approach to the intervention of the researcher. Consultation sessions will be held at the Ayatollah Mousavi Hospital Preparatory Classes and will be held under the supervision of a Compliance Professor (Cognitive-Behavioral Mindfulness-Based Stress Management).
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Maternity Hospitals Ayatollah Mousavi
Full name of responsible person
Fatemeh Aghamohammadi
Street address
Zanjan road gavazang of Ayatollah Mousavi Hospital
City
zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3313 1000
Email
fateme_am@yahoo.com

2

Recruitment center
Name of recruitment center
Department of Maternity Hospitals Imam hosin
Full name of responsible person
Fatemeh Aghamohammadi
Street address
Emam Hossein Hospital, Amjadiyeh Three Way, Early Culture Center
City
Zanjan
Province
Zanjan
Postal code
4519786911
Phone
+98 24 3301 1000
Email
fateme_am@yahoo.com

3

Recruitment center
Name of recruitment center
Maternity wards of Ayatollah Mousavi and Imam Hossein hospitals
Full name of responsible person
Fatemeh Aghamohammadi
Street address
Zanjan road gavazang of Ayatollah Mousavi Hospital
City
zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0651
Email
fateme_am@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
Chancellor for Research and Technology of Zanjan University of Medical Sciences, First floor, North Side Azadi Boulevard, Zanjan
City
zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0651
Email
r.kharaghani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Fatemeh Aghamohammadi
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan . shahrak karmandan, Faculty of Nursing Midwifery
City
zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 912 742 9115
Fax
Email
fateme_am@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Roghieh Kharaghani
Position
Ph.D of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Zanjan.shahrak karmandan, Faculty of Nursing Midwifer
City
zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Fax
Email
r.kharaghani@zums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Roghieh Kharaghani
Position
Ph.D of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
chool of Nursing and Midwifery, Karmandan town, zanjan
City
zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 912 562 5984
Fax
Email
r.kharaghani@zums.ac.ir
Web page address

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
A portion of the data associated with the original outcome will be shared.
When the data will become available and for how long
Start the access period from 1398
To whom data/document is available
Information will be available for scholars working in academic and academic institutions
Under which criteria data/document could be used
Apply this type of advice to another target group
From where data/document is obtainable
By e-mail address
What processes are involved for a request to access data/document
It will be answered by email and immediately after ensuring the plan is used.
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