Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04911504
Other study ID # JZhang
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 3, 2019
Est. completion date December 15, 2019

Study information

Verified date June 2021
Source Central South University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Among healthcare providers, nursing is a stressful and compassionate profession. Nurses empathetically support patients with pain, loneliness, disease and even confronted with death in line with their critically physical, mental, emotional, and spiritual needs and provide comfort, help, presence for them. Because nurses are frequently exposed to highly stressful and emotional situations, they suffer compassion fatigue (CF) over time under repeated exposures. CF will have a series of physiological, social, emotional, spiritual, and cognitive effects on nurses, threatening the existential integrity of them. The effects include high rates of anxiety and depressive disorders, decreased productivity, increased clinical errors, decreased quality of care and level of job satisfaction. Therefore, it is particularly important to pay attention to compassion fatigue to maintain mental health of nurses. Compassion fatigue refers to that in the process of providing assistance, the helper bears the pain of the recipient due to empathy, which reduces the helper's own energy or interest.Based on a widespread conceptual model, CF consists of two constructs: burnout and secondary traumatic stress. Nurses are at a great risk of compassion fatigue. CF is gradually becoming a serious problem which can affect nurses' physical and psychological health, performance, job satisfaction and quality of care . Thus, investigating the prevalence of CF among nurses and its related factors are warranted to prevent CF among nursing population. Research has studied the influencing factors of CF. Some studies have found that the demographic characteristics, worked related factors , the degree of exposure to traumatic events and psychological factors are important factors affecting nurses' compassion fatigue. Some studies suggest that resilience, social support, sense of control and meaningful recognition are negatively correlated with CF . Among them, resilience and self-efficacy are considered as important psychological factors affecting the individual's mental health, and they play an important role in the occurrence of CF. The working pressure of clinical nurses comes from the situations that they are exposed to patients' traumatic events and give excessive empathy for a long-term. CF among nurses is an undesirable outcome caused by maladaptation to this pressure. What's more, resilience, and self-efficacy play an important role in individual coping and psychological adjustment in face of stressful events. Therefore, it is necessary to explore the roles of resilience and self-efficacy in the process of CF. According to the theoretical path analysis of professional caregivers' quality of life, work environment, client environment and person environment factors have an influence on the development of compassion fatigue . Regarding to the psychological stress system , When confronted with stressful events, the individuals will have a stress response as a joint result of environmental factors and personnel factors. Thus, in accordance with the above two theories, being exposed to traumatic events is considered as a stressor, which could lead to CF. During this process, several external factors (work-related environmental factors) and internal factors (personality, social support) have effects on CF. In this study, resilience, and self-efficacy will be recognized as individual psychological characteristics and CF will be treated as a psychological change. Although there have been several studies on the predictors of CF in nurses around the world, limited knowledge exists in considering both internal factors (resilience and self-efficacy) and external predictive factors (demographic, work-related factors) of CF among nurses, especially in mainland China. The study aims to investigate the level of compassion fatigue among Chinese nurses and test the influences of demographic characteristics, work-related factors, resilience, and self-efficacy on compassion fatigue.


Description:

This study adopted a cross-sectional design. It was executed in accordance with STROBE Statement: guidelines for reporting observational studies. Through convenience sampling, clinical nurses from different departments were recruited from three tertiary hospitals in central China. According to the calculation method of the sample size regarding to the linear multiple regression, fixed model in G power software 3.1 was used. In this calculation, effect size f2=0.15, α= 0.05, 1-β=0.95, the study included 13 demographic variables, resilience and self-efficacy, 15 independent variables in total. The sample size calculated by G power software 3.1 is 199. Considering the 20% loss to follow-up rate and sampling error, the sample size was expanded to 239. Measurement The general information questionnaire The social-demographic questionnaire was self-compiled and aimed to collect participants' demographic characteristics such as age, gender, educational level, marital status, working department, years of nursing experience, professional title, monthly income, shift work and physical conditions and so on. Professional quality of life scale (Chinese version; ProQOL-CN) The Professional quality of life scale was used to evaluate the level of compassion fatigue. The original version was developed and then translated to Chinese. The scale has 30 items with three subscales including compassion satisfactory , burnout and secondary traumatic stress . Together, these latter two subscales measure compassion fatigue. A five-point Likert scale was used (1 = "never" to 5 = "very often") . A higher score of the compassion satisfaction subscale represents a higher level of compassion satisfaction, while a higher score of the burnout and secondary traumatic stress subscale indicates a higher risk of burnout and secondary traumatic stress. The score of each subscale lower than 22 represents a low level of compassion satisfaction, burnout, and secondary traumatic stress; score between 23 - 41 indicates an average level; and more than 42 suggests a high level . The Cronbach's alpha of the scale in this study was 0.722. Connor-Davidson resilience scale (Chinese version; CD-RISC) The CD-RISC aimed to measure participants' resilience. The Chinese version of CD-RISC consists of three dimensions (tenacity, strength, and optimism) with 25 items. A five-point Likert scale was used (0 = "never" to 4 = "almost always"). The scale can effectively measure the resilience among clinical nurses and has good reliability and validity . The reliability of the CD-RISC among Chinese residents was 0.91 and the Cronbach's alpha of the scale in this study was 0.966. General Perceived Self-Efficacy Scale (Chinese version; GSES) The GSES was used to measured participants' self-efficacy . The Chinese version consists of 10 items assessed by a four-point Likert scale (1=incorrect to 4=correct). The total scores range from 10 to 40, with higher total scores indicating higher levels of self-efficacy. The Cronbach's alpha of the scale in this study was 0.941. Procedures Data were collected from 3rd October, 2019 to 15th December, 2019 and the data collection was completed by a researcher and two research assistants. First, the researchers informed the directors and head nurses from each hospital of the study's purpose and got their permission to recruit nurses. Then, researchers introduced the contents of the questionnaires to research assistants in the hospital and explained how to complete it. Lastly, researchers distributed a Wenjuanxing link (an online crowdsourcing platform in China) involved the electronic research questionnaires by scanning a Quick Response code to research assistants. According to the inclusion criteria, nurses who had interests could contact the researchers and research assistants in hospital to participate in the study. Wenjuanxing is a relatively secure platform and there is no risk of any data breach and leakage by a third-party.


Recruitment information / eligibility

Status Completed
Enrollment 978
Est. completion date December 15, 2019
Est. primary completion date November 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - The hospital is a comprehensive hospital; - Nurse have been registered and are on their duty; - Nurses are currently engaged in clinical practice; - Nurses are willing to participate in the study. Exclusion Criteria: - Nurses who are intern nurses or studying in other hospitals, or has been participated in other relevant studies.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Xiangya School of Nursing,Central South University Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Central South University

Country where clinical trial is conducted

China, 

References & Publications (18)

Alharbi J, Jackson D, Usher K. Personal characteristics, coping strategies, and resilience impact on compassion fatigue in critical care nurses: A cross-sectional study. Nurs Health Sci. 2020 Mar;22(1):20-27. doi: 10.1111/nhs.12650. Epub 2019 Oct 31. — View Citation

Ariapooran S. Compassion fatigue and burnout in Iranian nurses: The role of perceived social support. Iran J Nurs Midwifery Res. 2014 May;19(3):279-84. — View Citation

Arimon-Pagès E, Torres-Puig-Gros J, Fernández-Ortega P, Canela-Soler J. Emotional impact and compassion fatigue in oncology nurses: Results of a multicentre study. Eur J Oncol Nurs. 2019 Dec;43:101666. doi: 10.1016/j.ejon.2019.09.007. Epub 2019 Sep 12. — View Citation

Balinbin CBV, Balatbat KTR, Balayan ANB, Balcueva MIC, Balicat MGB, Balidoy TAS, Macindo JRB, Torres GCS. Occupational determinants of compassion satisfaction and compassion fatigue among Filipino registered nurses. J Clin Nurs. 2020 Mar;29(5-6):955-963. doi: 10.1111/jocn.15163. Epub 2020 Jan 13. — View Citation

Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. — View Citation

Cetrano G, Tedeschi F, Rabbi L, Gosetti G, Lora A, Lamonaca D, Manthorpe J, Amaddeo F. How are compassion fatigue, burnout, and compassion satisfaction affected by quality of working life? Findings from a survey of mental health staff in Italy. BMC Health — View Citation

Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. — View Citation

Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149. — View Citation

Guo YF, Luo YH, Lam L, Cross W, Plummer V, Zhang JP. Burnout and its association with resilience in nurses: A cross-sectional study. J Clin Nurs. 2018 Jan;27(1-2):441-449. doi: 10.1111/jocn.13952. Epub 2017 Sep 4. — View Citation

Kelly L, Runge J, Spencer C. Predictors of Compassion Fatigue and Compassion Satisfaction in Acute Care Nurses. J Nurs Scholarsh. 2015 Nov;47(6):522-8. doi: 10.1111/jnu.12162. Epub 2015 Aug 19. — View Citation

Nolte AG, Downing C, Temane A, Hastings-Tolsma M. Compassion fatigue in nurses: A metasynthesis. J Clin Nurs. 2017 Dec;26(23-24):4364-4378. doi: 10.1111/jocn.13766. Epub 2017 Apr 20. — View Citation

Shen J, Yu H, Zhang Y, Jiang A. Professional quality of life: A cross-sectional survey among Chinese clinical nurses. Nurs Health Sci. 2015 Dec;17(4):507-15. doi: 10.1111/nhs.12228. Epub 2015 Aug 24. — View Citation

Sinclair S, Raffin-Bouchal S, Venturato L, Mijovic-Kondejewski J, Smith-MacDonald L. Compassion fatigue: A meta-narrative review of the healthcare literature. Int J Nurs Stud. 2017 Apr;69:9-24. doi: 10.1016/j.ijnurstu.2017.01.003. Epub 2017 Jan 12. Review. — View Citation

von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. — View Citation

Wang J, Okoli CTC, He H, Feng F, Li J, Zhuang L, Lin M. Factors associated with compassion satisfaction, burnout, and secondary traumatic stress among Chinese nurses in tertiary hospitals: A cross-sectional study. Int J Nurs Stud. 2020 Feb;102:103472. doi — View Citation

Yao Y, Zhao S, Gao X, An Z, Wang S, Li H, Li Y, Gao L, Lu L, Dong Z. General self-efficacy modifies the effect of stress on burnout in nurses with different personality types. BMC Health Serv Res. 2018 Aug 29;18(1):667. doi: 10.1186/s12913-018-3478-y. — View Citation

Zhang J, Zhang JP, Cheng QM, Huang FF, Li SW, Wang AN, Su P. The resilience status of empty-nest elderly in a community: A latent class analysis. Arch Gerontol Geriatr. 2017 Jan - Feb;68:161-167. doi: 10.1016/j.archger.2016.10.011. Epub 2016 Oct 26. — View Citation

Zhang YY, Han WL, Qin W, Yin HX, Zhang CF, Kong C, Wang YL. Extent of compassion satisfaction, compassion fatigue and burnout in nursing: A meta-analysis. J Nurs Manag. 2018 Oct;26(7):810-819. doi: 10.1111/jonm.12589. Epub 2018 Aug 20. Review. — View Citation

* Note: There are 18 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary General information of participants questionnaire The general information of participants was measured by social-demographic questionnaire which was self-compiled and aimed to collect participants' demographic characteristics such as age, gender, educational level, marital status, working department, years of nursing experience, professional title, monthly income, shift work and physical conditions and so on. baseline
Primary Compassion fatigue of participants The Professional quality of life scale was used to evaluate the level of compassion fatigue. The original version was developed by Stamm and then translated to Chinese by Zheng, which was authorized by Stamm. The scale has 30 items with three subscales including compassion satisfactory , burnout and secondary traumatic stress. Together, these latter two subscales measure compassion fatigue. A five-point Likert scale was used (1 = "never" to 5 = "very often") . A higher score of the compassion satisfaction subscale represents a higher level of compassion satisfaction, while a higher score of the burnout and secondary traumatic stress subscale indicates a higher risk of burnout and secondary traumatic stress. The score of each subscale lower than 22 represents a low level of compassion satisfaction, burnout, and secondary traumatic stress; score between 23 - 41 indicates an average level; and more than 42 suggests a high level. The Cronbach's alpha of the scale in this study was 0.722. baseline
Primary Resilience of participants The Connor-Davidson resilience scale aimed to measure participants' resilience. The original version was developed by Connor and Davidson . Yu and Zhang translated it to Chinese after getting the authorization from the original developers. The Chinese version of CD-RISC consists of three dimensions (tenacity, strength, and optimism) with 25 items. A five-point Likert scale was used (0 = "never" to 4 = "almost always") . The scale can effectively measure the resilience among clinical nurses and has good reliability and validity. The reliability of the CD-RISC among Chinese residents was 0.91 and the Cronbach's alpha of the scale in this study was 0.966. baseline
Primary Self-Efficacy of participants The General Perceived Self-Efficacy scale developed by Scherbaum, was used to measured participants' self-efficacy. The Chinese version was translated by Wang . The scale consists of 10 items assessed by a four-point Likert scale (1=incorrect to 4=correct). The total scores range from 10 to 40, with higher total scores indicating higher levels of self-efficacy. The Cronbach's alpha of the scale in this study was 0.941. baseline
See also
  Status Clinical Trial Phase
Completed NCT05114187 - An Internet-Based Education Program for Care Partners of People Living With Dementia N/A
Completed NCT05655364 - Development of a Breastfeeding Supportive Mobile Application N/A
Completed NCT04428034 - Learning Skills Together Pilot Study N/A
Recruiting NCT05914766 - An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer N/A
Completed NCT06395857 - Visual Arts-based Intervention for Community-dwelling Stroke Survivors N/A
Not yet recruiting NCT05623202 - Pilot Study of Capacity-oriented Intervention to Promote Food Security and Diet Quality Among Hispanics/Latinos N/A
Enrolling by invitation NCT02391766 - Group Intervention Empowerment Dementia Phase 0
Completed NCT01179854 - Remegal Different Doses in Patients With Refractory Partial Seizures Phase 2
Recruiting NCT06024083 - Skills Video Intervention for Chinese/Chinese Americans N/A
Completed NCT06384612 - The Effect Of The Use Of Pocket Cards In An Undergraduate Nursıng N/A
Completed NCT04087551 - Development of the Balance Recovery Falls-Efficacy Scale for the Community-dwelling Older Adults N/A
Recruiting NCT05512624 - Integrating a Mental Health Intervention Into Primary Health Care for Refugees N/A
Completed NCT04633434 - Evaluation Study of Talk Parenting Skills N/A
Not yet recruiting NCT04493944 - Edible Seaweeds and Health: Quality Biomarkers to Support Consumer Acceptance N/A
Completed NCT04867005 - Advance Care Planning in Primary Care: a Cluster Randomized Clinical Trial N/A
Completed NCT04161820 - The Effect of Education Based on the Chronic Care Model (StrokeCARE) in Patients With Ischemic Stroke N/A
Completed NCT06082895 - The Effect of Motivational Interviewing Method on Birth Self-efficacy N/A
Completed NCT05574764 - ABC Mental Health: A Behavioral Study of K-12 Teachers and School Staff N/A
Completed NCT03758027 - CARESS: An Investigation of Effects of CARESS N/A
Completed NCT04109651 - The Effect of Nursing Interventions on Maternal Attachment, Parental Self-efficacy and Infant Development N/A