Clinical trial NCT04415411: Effects of Nursing Care Provided to Relatives of Palliative Care Patients on Caregivers' Spiritual Well-being and Hope
Official title: Effects of Nursing Care Provided to the Relatives of Palliative Care Patients on Caregivers' Spiritual Well-being and Hope: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hope
Spirituality
Palliative Care
Keywords: family members
hope
nursing care
palliative care
spirituality
relatives
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, there are two groups as intervention group and control group. Investigator, administered not any application to control group. Nursing care which based on the Theory of Human Caring was given to intervention group for 4 weeks.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effects of nursing care provided based on the Watson's Theory of Human Caring to the relatives of palliative care patients on caregivers' spiritual well-being and hope. This research was conducted with 60 patient relatives (intervention group: 30, control group: 30) taking care of their patient in palliative care unit.

Detailed description: Every year, millions of patients as well as millions of patients are primarily involved in the palliative care process. It is emphasized that from the very start of palliative care process until grievance stage, patient relatives require a myriad of physical, psychological, social and spiritual needs. It has been widely reported that among relatives of palliative care patients, there is a high incidence of mental distress, depression, anxiety, sleep disturbance, fear and despair. The maintain of hope and spiritual well-being are important in dealing with this difficult process. Accordingly, nursing care is important, which supports the hope and spiritual well-being of patients' relatives. Nursing care that supports hope and focuses on spiritual dimensions is important in Watson's Human Care Theory.

Eligibility criteria: Inclusion Criteria:

* aged 18 and above
* willingness and motivation to participate in research
* literacy
* being the primary caregiver
* lack of mental or verbal deficiency to respond the questions

Exclusion Criteria:

* aged 18 below
* unwilling to participate in research
* illiterate
* non-primary caregiver
* mental or communicative disabilities

Primary outcomes:
measure: Hopeless level of patient relatives
timeFrame: 1. week
measure: Spiritual well-being level of patient relatives
timeFrame: 1. week
Secondary outcomes:
measure: Hopeless level of patient relatives (Change in level of hopeless after 4 weeks)
timeFrame: 4 weeks
measure: Spiritual well-being level of patient relatives (Change in level of spiritual well-being after 4 weeks)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
Study officials:
affiliation: Amasya University
name: Aslı Kurtgöz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ondokuz Mayıs University
name: Zeliha Koc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Korte-Verhoef MC, Pasman HR, Schweitzer BP, Francke AL, Onwuteaka-Philipsen BD, Deliens L. Burden for family carers at the end of life; a mixed-method study of the perspectives of family carers and GPs. BMC Palliat Care. 2014 Mar 31;13(1):16. doi: 10.1186/1472-684X-13-16.
citation: Gotze H, Brahler E, Gansera L, Polze N, Kohler N. Psychological distress and quality of life of palliative cancer patients and their caring relatives during home care. Support Care Cancer. 2014 Oct;22(10):2775-82. doi: 10.1007/s00520-014-2257-5. Epub 2014 May 9.
citation: Ullrich A, Ascherfeld L, Marx G, Bokemeyer C, Bergelt C, Oechsle K. Quality of life, psychological burden, needs, and satisfaction during specialized inpatient palliative care in family caregivers of advanced cancer patients. BMC Palliat Care. 2017 May 10;16(1):31. doi: 10.1186/s12904-017-0206-z.
citation: Oechsle K, Ullrich A, Marx G, Benze G, Heine J, Dickel LM, Zhang Y, Wowretzko F, Wendt KN, Nauck F, Bokemeyer C, Bergelt C. Psychological burden in family caregivers of patients with advanced cancer at initiation of specialist inpatient palliative care. BMC Palliat Care. 2019 Nov 18;18(1):102. doi: 10.1186/s12904-019-0469-7.