Effect of Nurse-Led Intervention Programme Professional Quality of Life and Psychological Distress in Nurses
Primary Purpose
Compassion Fatigue
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Nurse led intervention group
Sponsored by
About this trial
This is an interventional treatment trial for Compassion Fatigue focused on measuring burnout, compassion fatigue, nursing, psychological distress
Eligibility Criteria
Inclusion Criteria:
- Nurses who responded to the questionnaires received a score on compassion fatigue higher than the mean score (20 points)
- Nurses who worked at clinics and had at least six months of experience
Exclusion Criteria:
- Nurses who responded to the questionnaires received a score on compassion fatigue lower than the mean score (20 points)
- head nurses
Sites / Locations
- Neslihan Günüşen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nurse led intervention group
Control Group
Arm Description
The program was four sessions; It took about 1.5-2 hours. The intervention group was divided into two groups. The author who administered the intervention previously led nurse support groups, is also an active educator in psychiatry and mental health nursing, and has training in cognitive behavioral therapy. The group sessions were based on cognitive restructuring techniques.
No intervention was applied to the control group during the study.
Outcomes
Primary Outcome Measures
Change from baseline compassion fatigue at 1 and 6 months assessed by compassion fatigue subscale of Professional quality of life scale
The compassion fatigue subscale of ProQOL-IV includes 10-items. Completion of the compassion fatigue subscale involves selecting response choices on a 0 (never) to 5 (very often) likert scale. 0-50 points can be taken from the compassion fatigue subscale. There is no cut-point. A number of items required reverse coding so that high scores on all items indicate high compassion fatigue.
Change from baseline burnout at 1 and 6 months assessed by burnout subscale of Professional quality of life scale
The burnout subscale of ProQOL-IV includes 10-items. Completion of the burnout subscale involves selecting response choices on a 0 (never) to 5 (very often) likert scale. 0-50 points can be taken from the burnout subscale. There is no cut-point. A number of items required reverse coding so that high scores on all items indicate high burnout.
Change from baseline compassion satisfaction at 1 and 6 months assessed by compassion satisfaction subscale of Professional quality of life scale
The compassion satisfaction subscale of ProQOL-IV includes 10-items. Completion of the compassion satisfaction subscale involves selecting response choices on a 0 (never) to 5 (very often) likert scale. 0-50 points can be taken from the compassion satisfaction subscale. There is no cut-point. A number of items required reverse coding so that high scores on all items indicate high compassion satisfaction.
Secondary Outcome Measures
Change from baseline psychological distress at 1 and 6 months assessed by general health questionnaire
The GHQ-12 is a scale surveying psychiatric symptoms observed within the last few weeks. The items were evaluated on a 4-point likert-type scale. Scoring was as follows (a) and (b), 0 points; (c) and (d), 1 point; and the total possible score ranged between 0 and 12 points. The General Health Questionnaire-12 (GHQ-12) states that the nurses who score 2 and above risky.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03914898
Brief Title
Effect of Nurse-Led Intervention Programme Professional Quality of Life and Psychological Distress in Nurses
Official Title
Effect of Nurse-Led Intervention Programme on Compassion Fatigue, Burnout, Compassion
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Nurses are at risk in terms of burnout and empathic fatigue. Therefore, efforts to protect the mental health of nurses are very important. It is stated that the studies conducted are mostly descriptive and not interventional.
In addition, the evidence levels of interventional studies are low.
Detailed Description
Aim:The aim of this study is to reduce nurses' psychological distress, burnout and secondary trauma stress.
Design This single-blind randomized controlled trial design was used. Measurements were made before, after and 6 months after Participants and Settings The study was perform at a hospital in Turkey. Intervention program was applied in 4 week. 84 nurses meeting the criteria were invited to the program.48 nurses agreed to participate. Nurses were randomly assigned groups.
Sample Size the sample was calculated with the open epi program. The sample size was calculated as 20 per group.
Intervention The program was created to reduce nurses' psychological distress, and improve the professional quality of life.
The intervention programme were four sessions. The Intervention group was divided into two groups. Intervention were applied in a comfortable room in the hospital. Interventions were based on cognitive behavioral approach.
Outcome measures The outcomes were compassion fatigue, burnout and compassion satisfaction, psychological distress.
These variables were evaluated by the Professional Quality of Life Scale (ProQOL-IV). The GHQ-12 is a scale surveying psychological distress observed within the last few weeks.
Data collection Research data were collected before, immediately after, and six months after intervention.
Validity and reliability Measuring tools showing good psychometric properties were used to ensure validity and reliability. Volunteer participants were randomly assigned to groups, and the intention-to-treat approach was used for data analysis. The study has been reported in accordance with the CONSORT 2010 Statement principles.
Ethical considerations Permission was obtained from the relevant university, and written permission was obtained from the hospital. The participants were informed, all participants gave written consent.
Data analysis Mann Whitney U test, and Friedman analysis was used. All analyses were made on an intention-to-treat approach. Missing data were compensated for using the last observation method carried forward.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compassion Fatigue
Keywords
burnout, compassion fatigue, nursing, psychological distress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nurse led intervention group
Arm Type
Experimental
Arm Description
The program was four sessions; It took about 1.5-2 hours. The intervention group was divided into two groups. The author who administered the intervention previously led nurse support groups, is also an active educator in psychiatry and mental health nursing, and has training in cognitive behavioral therapy.
The group sessions were based on cognitive restructuring techniques.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention was applied to the control group during the study.
Intervention Type
Other
Intervention Name(s)
Nurse led intervention group
Intervention Description
This program is based on cognitive restructuring tecniques.
Primary Outcome Measure Information:
Title
Change from baseline compassion fatigue at 1 and 6 months assessed by compassion fatigue subscale of Professional quality of life scale
Description
The compassion fatigue subscale of ProQOL-IV includes 10-items. Completion of the compassion fatigue subscale involves selecting response choices on a 0 (never) to 5 (very often) likert scale. 0-50 points can be taken from the compassion fatigue subscale. There is no cut-point. A number of items required reverse coding so that high scores on all items indicate high compassion fatigue.
Time Frame
Data collected before the program starts and one months after the end of the program and six months
Title
Change from baseline burnout at 1 and 6 months assessed by burnout subscale of Professional quality of life scale
Description
The burnout subscale of ProQOL-IV includes 10-items. Completion of the burnout subscale involves selecting response choices on a 0 (never) to 5 (very often) likert scale. 0-50 points can be taken from the burnout subscale. There is no cut-point. A number of items required reverse coding so that high scores on all items indicate high burnout.
Time Frame
Data collected before the program starts (pretest) and one months after the end of the program and six months
Title
Change from baseline compassion satisfaction at 1 and 6 months assessed by compassion satisfaction subscale of Professional quality of life scale
Description
The compassion satisfaction subscale of ProQOL-IV includes 10-items. Completion of the compassion satisfaction subscale involves selecting response choices on a 0 (never) to 5 (very often) likert scale. 0-50 points can be taken from the compassion satisfaction subscale. There is no cut-point. A number of items required reverse coding so that high scores on all items indicate high compassion satisfaction.
Time Frame
Data collected before the program starts (pretest) and one months after the end of the program and six months
Secondary Outcome Measure Information:
Title
Change from baseline psychological distress at 1 and 6 months assessed by general health questionnaire
Description
The GHQ-12 is a scale surveying psychiatric symptoms observed within the last few weeks. The items were evaluated on a 4-point likert-type scale. Scoring was as follows (a) and (b), 0 points; (c) and (d), 1 point; and the total possible score ranged between 0 and 12 points. The General Health Questionnaire-12 (GHQ-12) states that the nurses who score 2 and above risky.
Time Frame
Data collected before the program starts (pretest) and one months after the end of the program and six months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Nurses who responded to the questionnaires received a score on compassion fatigue higher than the mean score (20 points)
Nurses who worked at clinics and had at least six months of experience
Exclusion Criteria:
Nurses who responded to the questionnaires received a score on compassion fatigue lower than the mean score (20 points)
head nurses
Facility Information:
Facility Name
Neslihan Günüşen
City
İzmir
ZIP/Postal Code
35340
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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17054155
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Results Reference
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Effect of Nurse-Led Intervention Programme Professional Quality of Life and Psychological Distress in Nurses
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