Compassion FatigueNCT03914898
Effect of Nurse-Led Intervention Programme Professional Quality of Life and Psychological Distress in Nurses
A study testing Nurse led intervention group in people with Compassion Fatigue, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Compassion Fatigue
- What is being tested?
- Nurse led intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Nurses who responded to the questionnaires received a score on compassion fatigue lower than the mean score (20 points)
- head nurses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Compassion Fatigue
- Being tested
- Nurse led intervention group
- Keywords
- burnout, compassion fatigue, nursing, psychological distress
- Medical subject headings
- Compassion Fatigue, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse led intervention groupOther
This program is based on cognitive restructuring tecniques.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nurse led intervention group |
| Control Group | No intervention | No intervention was applied to the control group during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Data collected before the program starts (pretest) and one months after the end of the program and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Feb 2017
- Primary completion30 Apr 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Compassion FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Partlak Günüşen, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914898
- Sponsor's protocol ID
- 3109-GOA
- Status last verified
- Dec 2020
- First submitted
- 8 Apr 2019
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 17054155Potter 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 23448743Pfaff 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 28471255Yilmaz 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 30079550Gunusen 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 21050201Kunzler 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nurse-Led Intervention Programme on Compassion Fatigue, Burnout, Compassion
- ClinicalTrials.gov ID
- NCT03914898
- Acronym / sponsor ID
- 3109-GOA
- Conditions
- Compassion Fatigue
- Keywords
- burnout, compassion fatigue, nursing, psychological distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse led intervention group | Experimental | Other: Nurse led intervention groupThe 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. |
| Control Group | No intervention | –No intervention was applied to the control group during the study. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Nurses who responded to the questionnaires received a score on compassion fatigue lower than the mean score (20 points)
- head nurses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse led intervention groupThis program is based on cognitive restructuring tecniques. | Other | Nurse led intervention group |
Primary outcome
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.
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.
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Background: PubMed 17054155Marine 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.
- Background: PubMed 23448743Potter 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.
- Background: PubMed 28471255Pfaff 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.
- Background: PubMed 30079550Yilmaz 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.
- Background: PubMed 21050201Gunusen 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.
- Derived from this study: PubMed 32627860Kunzler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse led intervention group in people with Compassion Fatigue, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03914898, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.