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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04415411
Other study ID # Interventional
Secondary ID PYO. SBF.1904.19
Status Completed
Phase N/A
First received
Last updated
Start date October 5, 2018
Est. completion date March 18, 2019

Study information

Verified date June 2020
Source Ondokuz Mayis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 147
Est. completion date March 18, 2019
Est. primary completion date March 18, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nursing care based on the Theory of Human Caring
Planned nursing care based on 10 caritas processes of Theory of Human Caring.

Locations

Country Name City State
Turkey Ondokuz Mayis University Samsun

Sponsors (1)

Lead Sponsor Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

Götze H, Brähler E, Gansera L, Polze N, Köhler 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Hopeless level of patient relatives Data were collected via Beck Hopelessness Scale. Maximum score to obtain from the scale varies in between 0-20. Higher scores obtained indicate that there is a high level of hopelessness in an individual. 1. week
Primary Spiritual well-being level of patient relatives Data were collected via Spiritual Well-Being Scale. Maximum score to obtain from the scale varies between 29-145. Higher score indicates stronger spiritual well-being. 1. week
Secondary Hopeless level of patient relatives (Change in level of hopeless after 4 weeks) Data were collected via Beck Hopelessness Scale. Maximum score to obtain from the scale varies in between 0-20. Higher scores obtained indicate that there is a high level of hopelessness in an individual. 4 weeks
Secondary Spiritual well-being level of patient relatives (Change in level of spiritual well-being after 4 weeks) Data were collected via Spiritual Well-Being Scale. Maximum score to obtain from the scale varies between 29-145. Higher score indicates stronger spiritual well-being. 4 weeks
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