Protocol summary

Study aim
Determining the effect of Cognitive-Behavioral Stress management training program on nurses’ emotional burnout and job productivity.
Design
A randomized, double-blind, controlled clinical trial of 40 nurses used a random numbers table.
Settings and conduct
Nurses of Roozbeh Hospital in Tehran, will be randomly divided into intervention and control groups using blocking method. Pre-test will be performed on both groups using questionnaires and The intervention group will then be trained in cognitive-behavioral stress management, but the control group will not receive any training. Cognitive-behavioral stress management intervention is done by Anthony et al. (2007) in ten sessions of each session for 90 to 120 minutes. The first part includes training in cognitive-behavioral techniques that are relevant to issues related to nurses' mental health, and the second part is related to training and practicing relaxation techniques. Then the post-test is performed on both groups through questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in research; Having a nursing degree; At least six months of experience in Roozbeh Hospital; Not taking drugs that affect the psyche; Not having more than two weeks off in the past month; Not having chronic stressful illnesses.
Intervention groups
The intervention group will be trained in cognitive-behavioral stress management, but the control group will not receive any training.
Main outcome variables
Nurses' emotional burn out; Nurses' Job productivity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220509054796N1
Registration date: 2022-05-18, 1401/02/28
Registration timing: prospective

Last update: 2022-05-18, 1401/02/28
Update count: 0
Registration date
2022-05-18, 1401/02/28
Registrant information
Name
Shadan Naghizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 0709
Email address
shadaannn997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-10, 1401/04/19
Expected recruitment end date
2022-07-20, 1401/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cognitive-Behavioral Stress Management Training Program on Emotional Exhaustion and Job Productivity of Nurses in Roozbeh hospital in 1401
Public title
The Effect of Cognitive-Behavioral Stress Management Training Program on Emotional Exhaustion and Job Productivity of Nurses
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in research Having a nursing degree At least six months of experience in Roozbeh Hospital
Exclusion criteria:
Taking drugs that affect the psyche (self-declaration) Having more than two weeks off in the past month Having chronic stressful illnesses such as cancer, asthma, diabetes
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Nurses of Roozbeh Hospital will enter the study through available sampling. Then they would randomly be divided into intervention and control groups using the blocking method. This would be The block randomization method, for example, the researcher considers the intervention group as A and the control group as B. The extent of each block of 4 is stable so in each block, there are two A (intervention) and two B (control), in this case, 6 situations are created, including the first mode (AABB), the second mode (ABAB), the third mode (ABBA), the fourth state (BABA), the fifth state (BBAA) and the sixth state (BAAB). We will roll a dice and for example, number 4 shows up, we would roll the (BABA) state again, for example, number 5 shows up (BBAA), and ... We will repeat rolling the dice until the sample is complete. To hide random allocation, blurred sealed envelopes with the letters inside will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
After obtaining informed consent and explaining to them that each of them will be randomly placed in one of the intervention and control groups, the studied nurses were randomly divided into two intervention and control groups by the researcher. The outcome assessor of the study was used to collect data without knowing the allocation of participants to different groups. Also, the statistical analyzer did not know how to group in the study and analyzed the data in general. After the intervention, the control group was trained and the intervention group was given to them.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery and Rehabilitation-Tehran University o
Street address
Unit.7, No.4, Narenj Alley, 6th Alley, Sazesh St, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1593814979
Approval date
2022-04-30, 1401/02/10
Ethics committee reference number
IR.TUMS.FNM.REC.1401.005

Health conditions studied

1

Description of health condition studied
Emotional Exhaustion
ICD-10 code
Z73.0
ICD-10 code description
Burn-out

2

Description of health condition studied
Job Productivity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Emotional Exhaustion
Timepoint
Before and After receiving Cognitive-Behavioral Stress Management Training
Method of measurement
Maslash and Jackson 1981 Emotional Exhaustion Questionnaire

2

Description
Job Productivity
Timepoint
Before and After receiving Cognitive-Behavioral Stress Management Training
Method of measurement
Job Productivity Questionnaire by Hershey and Blanchard 1984

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Anthony et al. (2007) performed Cognitive-Behavioral stress management intervention in ten sessions in groups, each session lasting 90 to 120 minutes (twice a week), each session consisting of two parts. The first part includes training Cognitive-Behavioral techniques that are relevant to issues related to nurses' mental health, and the second part is related to training and practicing relaxation techniques. The sessions will be performed in the form of Questions and Answers and group discussions. The structure of each session generally includes reviewing homework (5 minutes), reviewing the content of the previous session (5 minutes), presenting the first topic and practicing it (30 minutes), resting (5 minutes), presenting the second topic and practicing it (30 minutes), summary, discussing and conclusion (5 minutes), assigning homework for the next session (5 minutes). Due to the employment of the trainees and for the convenience of participating in the sessions, these training sessions will be conducted twice a week for five weeks.
Category
Prevention

2

Description
Control group: The control group will not receive any training, but at the end of the research, the training file will be given to them.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Shadan Naghizadeh
Street address
Roozbeh Hospital, Below the crossroads of Lashgar, South Kargar St.
City
Tehran
Province
Tehran
Postal code
13337 15914
Phone
+98 21 5541 9151
Email
shadaannn997@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shima Nazari
Street address
Mirkhani St, Tohid Ave
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
fnm@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
Shadan Naghizadeh
Position
Master Of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit.7, No.4, Narenj Alley, 6th Alley, Sazesh St, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1593814979
Phone
+98 21 8894 0709
Email
shadaannn997@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shadan Naghizadeh
Position
Master Of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit.7, No.4, Narenj Alley, 6th Alley, Sazesh St, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1593814979
Phone
+98 21 8894 0709
Email
shadaannn997@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shadan Naghizadeh
Position
Master Of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit.7, No.4, Narenj Alley, 6th Alley, Sazesh St, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1593814979
Phone
+98 21 8894 0709
Email
shadaannn997@gmail.com

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
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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