Protocol summary

Summary
This quasi-experimental study utilizes two control and intervention groups to detemination the effect of stress management program on response to stress in nurses working in neonatal intensive care units. The study setting is neonatal intensive care units in teaching hospitals affiliated to Iran University of Medical Sciences, and the study population is 70 nurses who comprises eligible working in these units. intervention and control groups are randomly selected to avoid likelihood of information leakage. Nurses are selected by convenient sampling method, and written consent is obtained from them. Their demographic data are collected and recorded using a questionnaire. In the pretest, all control and intervention groups complete Stress Response Inventory (SRI), containing seven subscales: tension, aggression, anger, depression, fatigue, frustration, and somatization. McNamara stress management teaching method is used in six one-hour sessions during six weeks. In each session, new topics are presented after reviewing previous ones. In this study, education program is not provided for participants in control groups during intervention. However, after completion of the intervention, all educational materials given to intervention groups are also made available to control groups. Eight weeks later, the questionnaire (SRI) is given to the intervention group nurses and inter- and intra-group results are compared.

General information

Acronym
not applicable
IRCT registration information
IRCT registration number: IRCT201509261788N13
Registration date: 2015-12-09, 1394/09/18
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-12-09, 1394/09/18
Registrant information
Name
Leili Borimnejad
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6150 4212
Email address
borimnej@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences Nursing Care Research Center
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of stress management program on response to stress in nurses at Neonatal Intensive Care Units "
Public title
Stress management to stress in nurses at Neonatal Intensive Care Units "
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Complete personal consent for participation in the study; a minimum of one year's clinical work experience; Bachelor’s degree or higher; no use of psychotropic drugs; working for four to six days per week; or 31 to 40 hours per week. Exclusion criteria: current depression; self-reported acute and chronic somatic or psychiatric disorders; medication.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
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
Iran University of Medical Sciences and Health Services
Street address
Iran, Tehran, Shahid Hemmat Highway West, between the intersection of Sheikh fazlolah Nori and Shahid Chamran
City
Tehran
Postal code
1996713883
Approval date
2015-08-05, 1394/05/14
Ethics committee reference number
IR.IUMS.REC.1394 . 9311451006

Health conditions studied

1

Description of health condition studied
stress
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders

Primary outcomes

1

Description
Stress managment
Timepoint
before, Immediately after the treatment, after eight week
Method of measurement
SRI Questionnare

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study, McNamara stress management is used in six one-hour sessions during six weeks, when NICU nurses receive educational intervention in groups of six. In each session, new topics are presented after reviewing previous ones, and issues discussed are summed up at the end of the session. Session one: Introduction to the importance of learning stress management skills; presenting definitions of stress. Session two: Introducing general effects of stress on various body systems, and examining physical, psychological, and behavioral effects of stress. Session three: Subjective and rational strategies for dealing with stress, and introducing problem-oriented and emotion-oriented methods as coping strategies, examining coping methods adopted by people in stressful situations. Session four: Introducing steps of coping skills, and working on the first stage: being aware of own feelings. Session five: The second step of stress control skills, physical ways of coping with stress: these are concerned with a healthier lifestyle, and include healthy nutrition, and sufficient sleep and exercise, which maintain and strengthen the immune system and increase energy level. Session six: Review of comments expressed by nurses and obtaining feedback, and SRI posttest. Personnel's stress is measured using pretest and posttest, and stress levels in two groups are compared through posttest and follow-up test. Eight weeks later, SRI is made available to nurses in the intervention group (posttest), in order to assess sustainability over time of stress management education provided by the researcher.
Category
Behavior

2

Description
Control group: No action is taken
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Teaching hospitals affiliated with Iran University of Medical Sciences
Full name of responsible person
Lelli Borimnenejad
Street address
Nursing and midwifery School
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
center for nursing care reaserch Iran University of Medical Sciences
Full name of responsible person
Sedighe Khanjari
Street address
Yasemi Street, Nursing and Midwhery School
City
Tehran
Grant name
مرکز تحقیقات مراقبتهای پرستاری
Grant code / Reference number
94-03-123-26475
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
center for nursing care reaserch Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University Of Medical Sciences
Full name of responsible person
Leili Borimnejad
Position
Ph.D / Educational Affair
Other areas of specialty/work
Street address
Yasemi Street , Nursing and Midwhery School
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2886
Fax
Email
l.borimnejad@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leili Borimnejad
Position
Ph.D / Associate Professor
Other areas of specialty/work
Street address
Yasemi Street, Nursing and Midwifery School
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2886
Fax
Email
l.borimnejad@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran university of Medical Sceinec
Full name of responsible person
Leili Borimnejad
Position
Ph.D
Other areas of specialty/work
Street address
Nursing and Midwifery School
City
Tehran
Postal code
19994
Phone
+98 21 8820 1880
Fax
Email
l.borimnejad@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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