Clinical trial NCT03914898: 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
Overall status: COMPLETED
Phase: NA
Conditions: Compassion Fatigue
Keywords: burnout
compassion fatigue
nursing
psychological distress
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 48
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline compassion fatigue at 1 and 6 months assessed by compassion fatigue subscale of Professional quality of life scale
timeFrame: Data collected before the program starts and one months after the end of the program and six months
measure: Change from baseline burnout at 1 and 6 months assessed by burnout subscale of Professional quality of life scale
timeFrame: Data collected before the program starts (pretest) and one months after the end of the program and six months
measure: Change from baseline compassion satisfaction at 1 and 6 months assessed by compassion satisfaction subscale of Professional quality of life scale
timeFrame: Data collected before the program starts (pretest) and one months after the end of the program and six months
Secondary outcomes:
measure: Change from baseline psychological distress at 1 and 6 months assessed by general health questionnaire
timeFrame: Data collected before the program starts (pretest) and one months after the end of the program and six months
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Neslihan Günüşen
Study officials:
References:
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