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CompletedNCT03914898Updated Dec 8, 2020

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

An interventional study of Nurse led intervention group in Compassion Fatigue, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-08.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Feb 2017, registered Apr 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Sex
Female
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Study 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.

Read the 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.

02

Conditions studied

  • Compassion Fatigue

Keywords

  • burnout
  • compassion fatigue
  • nursing
  • psychological distress
03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's enrollment of 48 is below the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Dokuz Eylul University is the lead sponsor of 252 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Nurses who responded to the questionnaires received a score on compassion fatigue lower than the mean score (20 points)
  • head nurses
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • 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

  • No intervention
    Control Group

    No intervention was applied to the control group during the study.

Interventions

  • OtherNurse led intervention group

    This program is based on cognitive restructuring tecniques.

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What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes

  1. 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.

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

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Study locations

1 site
  • Neslihan Günüşen
    İzmir, 35340, Turkey
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References and documents

Publications

  • Marine A, Ruotsalainen J, Serra C, Verbeek J. Preventing occupational stress in healthcare workers. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD002892. doi: 10.1002/14651858.CD002892.pub2. PubMed 17054155 ↗
  • Potter P, Deshields T, Berger JA, Clarke M, Olsen S, Chen L. Evaluation of a compassion fatigue resiliency program for oncology nurses. Oncol Nurs Forum. 2013 Mar;40(2):180-7. doi: 10.1188/13.ONF.180-187. PubMed 23448743 ↗
  • Pfaff KA, Freeman-Gibb L, Patrick LJ, DiBiase R, Moretti O. Reducing the "cost of caring" in cancer care: Evaluation of a pilot interprofessional compassion fatigue resiliency programme. J Interprof Care. 2017 Jul;31(4):512-519. doi: 10.1080/13561820.2017.1309364. Epub 2017 May 4. PubMed 28471255 ↗
  • Yilmaz G, Ustun B, Gunusen NP. Effect of a nurse-led intervention programme on professional quality of life and post-traumatic growth in oncology nurses. Int J Nurs Pract. 2018 Dec;24(6):e12687. doi: 10.1111/ijn.12687. Epub 2018 Aug 5. PubMed 30079550 ↗
  • Gunusen NP, Ustun B. An RCT of coping and support groups to reduce burnout among nurses. Int Nurs Rev. 2010 Dec;57(4):485-92. doi: 10.1111/j.1466-7657.2010.00808.x. Epub 2010 Sep 7. PubMed 21050201 ↗
  • Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2. PubMed 32627860 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03914898
Lead sponsor
Dokuz Eylul University
Responsible party
Neslihan Partlak Günüşen (Associate professor, Dokuz Eylul University) — Principal investigator
First posted
Apr 16, 2019
Start date
Feb 1, 2017
Primary completion
Apr 30, 2017
Completion
Sep 30, 2017
Last update
Dec 8, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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