NCT04415411

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

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

October 5, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

May 27, 2020

Last Update Submit

June 4, 2020

Conditions

Keywords

family membershopenursing carepalliative carespiritualityrelatives

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Hopeless level of patient relatives (Change in level of hopeless after 4 weeks)

    4 weeks

  • Spiritual well-being level of patient relatives (Change in level of spiritual well-being after 4 weeks)

    4 weeks

Study Arms (2)

Control group

NO INTERVENTION

Routine nursing care

Intervention group

EXPERIMENTAL

Nursing care based on the Theory of Human Caring

Other: Nursing care based on the Theory of Human Caring

Interventions

Planned nursing care based on 10 caritas processes of Theory of Human Caring.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University

Samsun, 55312, Turkey (Türkiye)

Location

Related 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.

    PMID: 24678941BACKGROUND
  • 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.

    PMID: 24811216BACKGROUND
  • 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.

    PMID: 28486962BACKGROUND
  • 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.

    PMID: 31739802BACKGROUND

Related Links

Study Officials

  • Aslı Kurtgöz, PhD

    Amasya University

    PRINCIPAL INVESTIGATOR
  • Zeliha Koc, PhD

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the research, it was not possible to blind the participants to group assignment. Additionally, due to the study being conducted for a doctoral thesis, data collection (pre and posttest), interviews, interventions and evaluation of data carried out by the same researcher who was not blinded.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 4, 2020

Study Start

October 5, 2018

Primary Completion

March 18, 2019

Study Completion

March 18, 2019

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

There are no plans

Locations