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

December 4, 2020 updated by: Neslihan Partlak Günüşen, Dokuz Eylul University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey, 35340
        • Neslihan Günüşen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nurse led intervention group

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.
Other: Nurse led intervention group
This program is based on cognitive restructuring tecniques.
NO_INTERVENTION: Control Group
No intervention was applied to the control group during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Data collected before the program starts and one months after the end of the program and six months
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.
Data collected before the program starts (pretest) and one months after the end of the program and six months
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.
Data collected before the program starts (pretest) and one months after the end of the program and six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Data collected before the program starts (pretest) and one months after the end of the program and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2017

Primary Completion (ACTUAL)

April 30, 2017

Study Completion (ACTUAL)

September 30, 2017

Study Registration Dates

First Submitted

April 8, 2019

First Submitted That Met QC Criteria

April 12, 2019

First Posted (ACTUAL)

April 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 4, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3109-GOA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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