Influence of omega-3 fatty acids in health care providers suffering from occupational burnout on symptoms of burnout, and saliva cortisol secretion – a randomized, double-blind, placebo-controlled clinical trial
Effect of omega-3 fatty acids on nursing burnout and salivary cortisol levels
Design
randomized ,double blind ,parallel, Clinical trials with control group
Settings and conduct
Occupational burnout nurses are randomly divided into two groups using colored card envelopes and treated with 100 mg of omega-3 or placebo for 8 weeks.
Participants/Inclusion and exclusion criteria
Burnout nurses who have written written consent to the study and received no supplementary medication in the last three months.
Intervention groups
The intervention group received omega-3 capsules and the control group received placebo capsules
Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 4184
Email address
haghighi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of omega-3 fatty acids in health care providers suffering from occupational burnout on symptoms of burnout, and saliva cortisol secretion – a randomized, double-blind, placebo-controlled clinical trial
Public title
Influence of omega-3 fatty acids on health care provider burn out
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosis of burnout
Written consent
Exclusion criteria:
Use of complementary medications in the last three months
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
30 red cards and 30 blue cards are placed in a non-transparent packets, Each person picks up a packet, Each color is considered for a group
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, placebo, which is precisely in the form of a drug product, is administered randomly to the patients and explained to the patients that he or she may receive a drug or placebo. Therefore, the patient and the clinical caregiver are not aware of the type of product.The other person other than the investigator is responsible for the preparation of the drug and placebo boxes and the researcher is not aware of it. The investigator of the outcome is also unaware of the type of product.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
ِFahmideh Bulvar.Mahdieh street
City
Hamadan
Province
Hamadan
Postal code
65178
Approval date
2018-04-22, 1397/02/02
Ethics committee reference number
IR.UMSHA.REC.1397.1
Health conditions studied
1
Description of health condition studied
Occupational Burnout
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Maslach Burnout Questionnaire score
Timepoint
Before the intervention, 4 weeks and 8 weeks after the intervention
Method of measurement
Maslach Burnout Questionnaire
2
Description
saliva cortisol
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Cortisol Saline Measure Kit
Secondary outcomes
1
Description
Beck Depression Inventory score
Timepoint
Before the intervention,4weeks and 8 weeks after intervention
Method of measurement
Beck Depression Inventory
2
Description
Insomnia Severity Index score
Timepoint
Before the intervention,4weeks and 8 weeks after intervention
Method of measurement
Insomnia Severity Index
Intervention groups
1
Description
Intervention group: Omega-3 capsules at a dose of 1000 mg daily for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule daily for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Mohammad haghighi
Street address
Dibaj Street
City
Hamadan
Province
Hamadan
Postal code
65175
Phone
+98 81 3827 1066
Email
haghighi@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Ahmadpanah
Street address
fahmideh Bulvar, Mahdieh street
City
Hamadan
Province
Hamadan
Postal code
65175
Phone
+98 81 3827 1066
Email
m1ahmad2000@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Position
Preofessor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital,Dibaj street
City
Hamadan
Province
Hamadan
Postal code
65175
Phone
+98 81 3827 1066
Email
haghighi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Position
Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital,Dibaj street
City
Hamadan
Province
Hamadan
Postal code
65175
Phone
+98 81 3827 1066
Email
haghighi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Ahmadpanah
Position
Associate professor of Psycology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Farshchian Hospital,Dibaj street
City
Hamadan
Province
Hamadan
Postal code
65175
Phone
+98 81 3827 1066
Email
m1ahmad2000@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
Not applicable
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