Effects of Nursing Care Provided to Relatives of Palliative Care Patients on Caregivers' Spiritual Well-being and Hope

June 4, 2020 updated by: Asli Kurtgöz, Ondokuz Mayıs University

Effects of Nursing Care Provided to the Relatives of Palliative Care Patients on Caregivers' Spiritual Well-being and Hope: A Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey, 55312
        • Ondokuz Mayıs University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Routine nursing care
Experimental: Intervention group
Nursing care based on the Theory of Human Caring
Other: Nursing care based on the Theory of Human Caring
Planned nursing care based on 10 caritas processes of Theory of Human Caring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hopeless level of patient relatives
Time Frame: 1. week
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
Time Frame: 1. week
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hopeless level of patient relatives (Change in level of hopeless after 4 weeks)
Time Frame: 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
Spiritual well-being level of patient relatives (Change in level of spiritual well-being after 4 weeks)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Investigators

  • Principal Investigator: Aslı Kurtgöz, PhD, Amasya University
  • Principal Investigator: Zeliha Koc, PhD, Ondokuz Mayıs University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2018

Primary Completion (Actual)

March 18, 2019

Study Completion (Actual)

March 18, 2019

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Interventional (Oncolys BioPharma Inc)
  • PYO. SBF.1904.19.006 (Other Grant/Funding Number: Ondokuz Mayıs University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There are no plans

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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