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Completed

NCT Number: NCT03914898

Effect of Nurse-Led Intervention Programme Professional Quality of Life and Psychological Distress in Nurses

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.

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Key information

Conditions

Compassion Fatigue Behavior Behavioral Symptoms Burnout, Psychological Fatigue Mental Fatigue Occupational Stress Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress, Psychological

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Neslihan Günüşen

Izmir, 35340, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse led intervention group

Other

This program is based on cognitive restructuring tecniques.

Primary outcomes

  1. Change from baseline compassion fatigue at 1 and 6 months assessed by compassion fatigue subscale of Professional quality of life scale

    Time frame: Data collected before the program starts and one months after the end of the program and six months

    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.

  2. Change from baseline burnout at 1 and 6 months assessed by burnout subscale of Professional quality of life scale

    Time frame: Data collected before the program starts (pretest) and one months after the end of the program and six months

    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.

  3. Change from baseline compassion satisfaction at 1 and 6 months assessed by compassion satisfaction subscale of Professional quality of life scale

    Time frame: Data collected before the program starts (pretest) and one months after the end of the program and six months

    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 outcomes

  1. Change from baseline psychological distress at 1 and 6 months assessed by general health questionnaire

    Time frame: Data collected before the program starts (pretest) and one months after the end of the program and six months

    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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

Effect of Nurse-Led Intervention Programme on Compassion Fatigue, Burnout, Compassion

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 16, 2019
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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