Protocol summary

Study aim
Investigating the impact of mindfulness-based stress reduction on nurses' workplace well-being and nurse-patient interpersonal reactions in psychiatric wards.
Design
In this single-center clinical trial with a control group without blinding, 66 nurses will be selected. Then the participants are placed in one of two intervention or control groups using simple randomization in a computer algorithm with an equal allocation ratio (1:1).
Settings and conduct
This study will be conducted at Ibn Sinai Psychiatric Hospital in Mashhad City. The intervention will be implemented for 8 weeks as a 2-hour session every week for the intervention group. The control group will not receive any intervention. Then, immediately after the intervention and three months after the onset of the intervention, the study tools will be completed by the nurses participating in the research.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Consent to participate in the research Having a bachelor's degree in nursing or higher Exclusion criteria: Participation in stress control courses during the last year Having a history of psychiatric disorders or disorders in the cognitive status, according to the participant's own report
Intervention groups
In this eight-week intervention, a body scan is performed in the first and second weeks. During the third and fourth weeks, the body scanning exercise begins with yoga. In the fifth and sixth weeks, the practice of body scanning stops, and sitting and focusing on breathing begins so that breathing will be used as an act to control attention. In the seventh week, in this week people generally use sitting techniques, yoga, and body scanning. In the eighth week, in this week, the subjects are asked to choose one of the taught techniques that fit their situation.
Main outcome variables
Workplace well-being Nurse-patient interpersonal activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230316057739N1
Registration date: 2023-05-16, 1402/02/26
Registration timing: prospective

Last update: 2023-05-16, 1402/02/26
Update count: 0
Registration date
2023-05-16, 1402/02/26
Registrant information
Name
JAVAD FATEMI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3700 2342
Email address
fatemij2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-07-11, 1402/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intervention of mindfulness based on stress reduction (MBSR) on the workplace well-being and nurse-patient interpersonal among nurses working at the psychiatric wards
Public title
The effect of intervention of mindfulness based on stress reduction (MBSR) on the workplace well-being and nurse-patient interpersonal among nurses
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the research Having a bachelor's degree or above in nursing
Exclusion criteria:
Having a history of participation in stress control courses in the past year Having psychiatric disorders or impaired cognitive status according to the participants' self-report
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 33
Randomization (investigator's opinion)
Randomized
Randomization description
The limited randomization method applying the law of random allocation will be used. At first, 33 sealed cards related to the intervention group and 33 sealed cards related to the control group will be prepared. These cards will be placed in the lottery container. Then the cards are randomly removed from the container without replacement and the created sequence is recorded. Each of the created random sequences is recorded on a card and each card is placed inside opaque envelopes. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the envelopes is glued and placed in a box in order. For each of the participants, one of the letter envelopes is opened in order and the assigned group of that participant is revealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
In this study, two groups i.e. intervention and control group, will participate. For the intervention group, the mindfulness program based on stress reduction will be implemented for 8 weeks. At this time, the control group will receive routine services.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of birjand University of Medical Sciences
Street address
Birjand-Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853076
Approval date
2023-03-12, 1401/12/21
Ethics committee reference number
IR.BUMS.REC.1401.447

Health conditions studied

1

Description of health condition studied
Workplace well-being
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Nurse-patient interpersonal interaction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Workplace well-being
Timepoint
Before the intervention, immediately after the intervention and three months after the start of the intervention
Method of measurement
The idiomaniac workplace well-being scale will be used to evaluate workplace well-being. The clinical interpersonal reaction index will be used to evaluate the nurse-patient interpersonal reaction.

2

Description
Nurse-patient interpersonal interaction
Timepoint
Outcomes will be measured before the intervention, immediately after the intervention, and 3 months after the start of the intervention.
Method of measurement
The idiomaniac workplace well-being scale will be used to evaluate workplace well-being. This scale has two intrapersonal and interpersonal dimensions. Each dimension contains 4 items. The clinical interpersonal reaction index with 18 items will be used to evaluate the nurse-patient impersonal reaction. This is a two-dimensional tool of perspective-taking and unconditional positive regard.

Secondary outcomes

empty

Intervention groups

1

Description
For the intervention group, an eight-week intervention will be conducted in the form of two-hour sessions that will be held every week. In the first and second weeks, the body is scanned. During the third and fourth weeks, the body scanning exercise begins with yoga and the participants continue to practice thinking with breathing in a sitting position for 15 to 20 minutes. In the fifth and sixth weeks, the practice of body scanning stops, and sitting and focusing on breathing begins so that breathing will be used as an act to control attention. In the seventh week, in this week people generally use sitting techniques, yoga, and body scanning. In the eighth week, in this week, the subjects are asked to choose one of the taught techniques that fit their situation.
Category
Lifestyle

2

Description
Control group: no intervention will be done for the control group. In other words, the nurses of this group will receive routine services.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibn sina hospital
Full name of responsible person
Javad Fatemi
Street address
Mashhad-Hor e ameli blv
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3700 2342
Email
Fatemij2@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyyed Abolfazl Vagharseyyedin
Street address
Ayatollah Ghaffari Avenue, Birjand, Iran. Postal code: 9717853577
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
waghars@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Javad Fatemi
Position
Employee
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad, Hor e ameli blv
City
Mashhad
Province
South Khorasan
Postal code
9195983134
Phone
+98 51 3700 2342
Email
Fatemij2@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Javad Fatemi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad - Hor e ameli blvd
City
Birjand
Province
South Khorasan
Postal code
9195983134
Phone
+98 51 3700 2342
Email
Fatemij2@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Javad Fatemi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Birjand - Ghaffari Street
City
Bhrjand
Province
South Khorasan
Postal code
9195983134
Phone
+98 51 3700 2342
Email
Fatemij2@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Loading...