NCT03914898

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

April 8, 2019

Last Update Submit

December 4, 2020

Conditions

Keywords

burnoutcompassion fatiguenursingpsychological distress

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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

    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 Outcomes (1)

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

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

Study Arms (2)

Nurse led intervention group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

This program is based on cognitive restructuring tecniques.

Nurse led intervention group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neslihan Günüşen

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 17054155BACKGROUND
  • 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.

    PMID: 23448743BACKGROUND
  • 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.

    PMID: 28471255BACKGROUND
  • 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.

    PMID: 30079550BACKGROUND
  • 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.

    PMID: 21050201BACKGROUND
  • 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.

MeSH Terms

Conditions

Compassion FatigueBurnout, Psychological

Condition Hierarchy (Ancestors)

Mental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorOccupational StressStress, Psychological

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 16, 2019

Study Start

February 1, 2017

Primary Completion

April 30, 2017

Study Completion

September 30, 2017

Last Updated

December 8, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations