- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04620005
Impact of Extra Corporal Membrane Oxygenation Services on Burnout Development in Intensive Care Units. (burnout)
The burnout phenomenon first came to clinical science 50 years ago. It is exponentially rising worldwide which prompted its discoverers to develop the most popular tool for its assessment, known as the Maslach burnout inventory (MBI)1. Common symptoms of burnout include depression, irritability, and insomnia. The growing demand for extra-corporeal membrane oxygenation (ECMO) may have an effect on burnout as the newly introduced services is demanding in effort and put the practitioners on complex ethical and administrative situations.
We conducted a cross-sectional descriptive study using a combined methodological quantitative and qualitative approach involving a convenience sample of 1000 healthcare practitioners within surgical and medical ICUs of Hamad Medical Corporation (HMC), Qatar. We will use used two main instruments to develop an online questionnaire: - The MBI-human service survey (MBI-HSS) and the Leadership scale Expectations: we expect that we will have a new insight about the impact of these complex interventions on practitioner's burnout.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study predominates at investigating the BOS in ECMO ICU and non-ECMO ICU, and whether the leadership attitude could have effect on the mentioned syndrome problem.
Methodology Settings This study will in a tertiary hospital in the Middle East "Hamad Medical Corporation" as a main centre, the study will be disseminated an online survey among other centres who will agree to participate on. The participants will be screened for socio-demographic data such as age, gender, profession, marital state, education, native country, years of experience, weekly working hours and salary. The questionnaire was clarified to the potential respondents in order to clear any poor understanding. English used as the official language in the organization; translation of the used instruments to individual mother languages is not required.
Design Cross-sectional descriptive survey with purposeful sampling. Mixed qualitative and quantitative methodology used in this dissertation. Invitations to participate through the mail, anonymous questionnaire survey will be presented to the staff members including physicians, nurses and respiratory therapists who work as full time.
1. Study Population and Study Setting/ Location In this section describe the study population that is to be enrolled in the study, planned recruitment number and Inclusion and Exclusion Criteria to be listed here. Also list the Hospitals in which this study will be conducted ( e.g. HGH, Rumailah etc) The study population would include physicians, nurses, and respiratory therapists working in ICUs. The inclusion criteria will include practitioners working in intensive care unit including physician, respiratory therapists and nurses who agree to participate in the survey. We will exclude practitioners who decline to participate and who will not complete the questionnaires. A flow diagram will be prepared for the enrollment.
The participants will be approached through communication with one representative within the assigned ICUs within Qatar, in case of agreement we will ask for a list of mails from each department to be enrolled in the study.
1. Study procedures
The study will be conducted for 12 months from the time of ethical approval. Instrumentation
The used instrumentation is questionnaire that is divided into the following sections:
A) Condition of work effectiveness questionnaire (CWEQ): This scale consisted of 19 items developed by Kanter, (1977) measured by a 5-point Likert type response. (9) B) Maslach Burnout Inventory human services survey (MBI-HSS): The scale is a standardized instrument to measure burnout it utilize 9 items related to emotional exhaustion and it is most frequently used in health care researches, the nine items are calculated to get the whole score, scores of 27 and more signals severe burnout. (10) The percentage of high degree of burnout was used for advanced analysis. We will get permission to use this scale from (Mindgarden.com, USA) C) Leadership Behaviours scale (LS): The staff discernment of managers' leadership attitude will be measured using the 11 item Manager Action Scale. (11)
The questionnaires will be submitted in English form; no need for translation, as health care practitioners in the organization, must practice English that is the official language at workplace. The results of the analysis will be presented using descriptive methods. The quantitative and qualitative data will be analysed statistically, the relations between the variables will be interpreted, the relation between burnout score and socio-demographic variables, occupational stress score, and empowerment scale will be assessed statistically using (t-test, analysis of variance, correlation efficient and regression).
Ethical Considerations:
Participant identity kept confidential, final report would not contain any identity. Comprehensive explanation for the participants about the questionnaires, the type, purpose of the study and outcome was done, early rejection, or late withdrawal was permissive. Ethical approval was obtained according to the corporate regulations. The ethical consent attached after being approval from the medical research centre.
Health care practitioners working on ICU whether providing ECMO services or not will be eligible to participate in the study
The primary objective will be to detect the prevalence of burnout among health care practitioner s working in ICU with ECMO services The secondary objectives will be to compare the burnout association in ECMO and non ECMO ICU, the effect of leadership attitude on burnout syndrome and to look at the burnout in special population within the groups like respiratory therapists
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
DA
-
Doha, DA, Qatar, 3050
- Hamad Medical Corporation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- The inclusion criteria will include practitioners working in intensive care unit including physician, respiratory therapists and nurses who agree to participate in the survey
Exclusion Criteria:
practitioners who decline to participate and who will not complete the questionnaires.
- Non ICU practitioners
- Perfusionists
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ECMO
The first group will include practitioners who work in intensive care unit with ECMO services
|
Survey
|
|
Non-ECMO
The second group will include practitioners who work in non-ECMO inventive care unit
|
Survey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Questionnaire assessing prevalence of burnout among health care practitioners working in ICU with ECMO services
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The difference in burnout association in practitioners in ICU with ECMO services and in conventional ICU
Time Frame: 1 year
|
1 year
|
|
|
effect of leadership attitude on burnout syndrome
Time Frame: 1 year
|
Through specific questionnaire
|
1 year
|
|
burnout in special population within the respiratory therapists
Time Frame: 1 years
|
1 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Moss M, Good VS, Gozal D, Kleinpell R, Sessler CN. An Official Critical Care Societies Collaborative Statement: Burnout Syndrome in Critical Care Health Care Professionals: A Call for Action. Am J Crit Care. 2016 Jul;25(4):368-76. doi: 10.4037/ajcc2016133.
- Poncet MC, Toullic P, Papazian L, Kentish-Barnes N, Timsit JF, Pochard F, Chevret S, Schlemmer B, Azoulay E. Burnout syndrome in critical care nursing staff. Am J Respir Crit Care Med. 2007 Apr 1;175(7):698-704. doi: 10.1164/rccm.200606-806OC. Epub 2006 Nov 16.
- Mealer M, Burnham EL, Goode CJ, Rothbaum B, Moss M. The prevalence and impact of post traumatic stress disorder and burnout syndrome in nurses. Depress Anxiety. 2009;26(12):1118-26. doi: 10.1002/da.20631.
- Omar AS, Elmaraghi S, Mahmoud MS, Khalil MA, Singh R, Ostrowski PJ. Impact of leadership on ICU clinicians' burnout. Intensive Care Med. 2015 Nov;41(11):2016-7. doi: 10.1007/s00134-015-4008-6. Epub 2015 Aug 8. No abstract available.
- Chuang CH, Tseng PC, Lin CY, Lin KH, Chen YY. Burnout in the intensive care unit professionals: A systematic review. Medicine (Baltimore). 2016 Dec;95(50):e5629. doi: 10.1097/MD.0000000000005629.
- Omar AS, Labib A, Hanoura SE, Rahal A, Kaddoura R, Chughtai TS, Karic E, Shaikh MS, Hamad WJ, ElHassan M, AlHashemi A, Khatib MY, AlKhulaifi A. Impact of Extracorporeal Membrane Oxygenation Service on Burnout Development in Eight Intensive Care Units. A National Cross-Sectional Study. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt B):2891-2899. doi: 10.1053/j.jvca.2022.02.018. Epub 2022 Feb 18.
- Omar AS, Hanoura S, Labib A, Kaddoura R, Rahhal A, Al-Zubi MM, Galvez RD, Shiju S, Al Jonidi MJ, Ragab H, Al Hashemi AA, Alumlla A. Burnout among Respiratory Therapists and Perception of Leadership: A Cross Sectional Survey Over Eight Intensive Care Units. J Intensive Care Med. 2022 Dec;37(12):1553-1562. doi: 10.1177/08850666221086208. Epub 2022 Mar 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRC-01-20-113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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