The effectiveness of online mindfulness training based on stress reduction (MBSR) on mental health and quality of work life of nurses fighting on the frontlines against COVID-19
The effectiveness of stress-based online mindfulness training on the mind health & the quality of work lifeof nurses working on the front lines of the fight against Covid-19
Design
A phase-blind, randomized, single-sided (data analyzers) clinical trial will be performed on 36 nurses working on the Covid-19 frontline. A table of random numbers will be used.
Settings and conduct
This project will be carried out in Taleghani Educational and Medical Center affiliated to Urmia University of Medical Sciences and the intervention group will be trained online at home for 8 weeks.
Participants/Inclusion and exclusion criteria
Full time employee. At least 2 years of service. At least 3 months of work experience in the "ICU" department (due to adaptation to the work environment). Absence of acute psychiatric illnesses such as psychosis. If medical drugs are used, the dose of the drug is stable during exercise and if the dose is changed, inform the researchers. Not addicted to drugs and alcohol. Lack of previous experiences of mindfulness.Do not receive any psychological interventions and counseling during exercise from other sources. Absence of acute physical illness with pain that prevents exercise.
Exclusion criteria also include the absence of more than 10% of the training time, leave and cause with a major stressful event (including coronary heart disease, imminent death, divorce, etc.) in the existence of research has it.
Intervention groups
Intervention group: including nurses working on the front line of the fight against Covid-19 who will participate in a stress-based mindfulness training program for 8 sessions.
Control group: including nurses working on the front line of the fight against Covid-19 who will participate in a stress-based mindfulness training program after completing the research.
Main outcome variables
Mental health
Quality of working life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181203041832N1
Registration date:2020-10-05, 1399/07/14
Registration timing:registered_while_recruiting
Last update:2020-10-05, 1399/07/14
Update count:0
Registration date
2020-10-05, 1399/07/14
Registrant information
Name
Haedeh Feizipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3193 7286
Email address
feizipour.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of online mindfulness training based on stress reduction (MBSR) on mental health and quality of work life of nurses fighting on the frontlines against COVID-19
Public title
The effectiveness of online mindfulness training on mental health and quality of work life of nurses fighting on the frontlines against COVID-19
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Full time employee
At least 2 years of service
At least 3 months of work experience in the "ICU" (due to adaptation to the work environment)
Ability to use an online application through an Internet-connected device (e.g. smartphone, computer or laptop)
Access the online Skyroom app
Non-interference of the training program with nurses' shifts
Provided that the medication is taken, inform the researchers if the dose of the medication is stable during the exercise, or if the dose changes
Commitment to daily mindfulness exercises and active participation in the training course.
Exclusion criteria:
Acute psychiatric illnesses such as psychosis
Psychiatric medication for the past 6 months
Acute physical illness with pain that prevents exercise
Addiction to drugs and alcohol
Previous experiences of mindfulness
Psychological interventions or counseling during exercise from other sources
Facing a severe traumatic event in the last 6 months
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the fact that patients with COVID-19 are admitted to Taleghani Hospital in Urmia, so first to achieve the objectives of the study and according to the conditions of admission, 36 people will be selected based on purposive sampling. Then this number will be divided into two groups of intervention (n = 18) and control (n = 18) completely randomly. It should be noted that the selected samples will be coded from number one to 36 and then will be placed in one of the intervention or control groups based on the table of random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
It should be noted that first the subjects will be explained about the objectives of the study and after their agreement to participate in the present study will be selected as the study sample, in the present study only responsible for data analysis about the objectives of the study , Will be kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the intervention group will be trained for 8 weeks, but the control group will not receive any training and after completing the research, will participate in this course if desired.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Jahad Square, Resalat Blvd., Emergency Alley,
City
Urmia
Province
West Azarbaijan
Postal code
5715974147
Approval date
2020-06-02, 1399/03/13
Ethics committee reference number
IR.UMSU.REC.1399.105
Health conditions studied
1
Description of health condition studied
There is not disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Depression Score in Symptom Checklist 90-Revised (SCL-90-R)
Timepoint
Before intervention - Immediately after intervention - One month after intervention
Method of measurement
Symptom Checklist 90-Revised (SCL-90-R)
2
Description
Stress score in the Symptom Checklist 90-Revised (SCL-90-R)
Timepoint
Before - after - one month after the intervention
Method of measurement
Symptom Checklist 90-Revised (SCL-90-R)
3
Description
Pathological fear score in the Symptom Checklist / SCL 90
Timepoint
Before - after - one month after the intervention
Method of measurement
Symptom Checklist 90-Revised (SCL-90-R)
4
Description
Psychosomatic disorders score in the Symptom Checklist 90-Revised (SCL-90-R)
Timepoint
Before - after - one month after the intervention
Method of measurement
Symptom Checklist 90-Revised (SCL-90-R)
5
Description
ََAggression score in the mental disorders Symptom Checklist 90-Revised (SCL-90-R)
Timepoint
Before - after - one month after the intervention
Method of measurement
Symptom Checklist 90-Revised (SCL-90-R)
6
Description
Obsessive-compulsive disorder score in the symptom checklist scl90
Timepoint
Before - after - one month after the intervention
Method of measurement
Symptom Checklist 90-Revised (SCL-90-R)
7
Description
Interpersonal Sensitivity Score in Symptom Checklist 90-Revised (SCL-90-R)
Timepoint
Before - after - one month after the intervention
Method of measurement
Symptom Checklist 90-Revised (SCL-90-R)
8
Description
Quality of work life score in the Work‐Related Quality of Life scale for healthcare workers
Timepoint
Before - after - one month after the intervention
Method of measurement
The Work‐Related Quality of Life scale for healthcare workers
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The Nurses working on frontline of fighting against COVID-19 disease. The intervention that is to be done in this scientific study is: Mindfulness-Based Stress Reduction (MBSR). Mindfulness-based stress reduction is a group program that was developed by Jon Kabat-Zinn in the 1970s to treat patients struggling with life’s difficulties and physical and/or mental illness (Kabat-Zinn, 2013). This training course is held in 8 online sessions (one session of 1.5 hours per week) for the nurses of the intervention group. Formal exercises include: 1. Body Scan 2. The Breath (exercise that facilitates mindfulness by focusing on the breath). 3. Mindful Eating 4. Sitting exercise 5.Walking Meditation 6.Mindful Stretching 7. Simply Watching
Category
Treatment - Other
2
Description
Control group: Will not receive any intervention until the research project is completed
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the confidentiality and confidentiality of personal data
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Only part of the data, such as the original outcome information, can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic institutions
Under which criteria data/document could be used
The required training and guidance will be provided for similar studies and scientific researches.
From where data/document is obtainable
by Email:
h.feizipour@gmail.com
What processes are involved for a request to access data/document
1. Full introduction of the applicant that must be one of the researchers of academic institutions
2. Sending her/his research resume to the mentioned email address
3. Sending a response to the researcher's request via email within 3 weeks