Comfort and Quality of Life of Patients at the End of Life

A Study to Evaluate The Effects Of Nursing Care İmplementations Based On Kolcaba's Comfort Theory For The End Of Life Patients Comfort Levels and The Life Quality

A Research to Evaluate the Effect of Nursing Care Practices Based on Kolcaba's Comfort Theory on the Comfort Levels and Quality of Life of End-of-Life Patients.

Purpose: The study was carried out as a semi-experimental posttest with independent groups and a control group, in order to determine the effect of nursing care interventions on the patient's quality of life comfort level, based on Kolcaba's comfort theory. end-of-life patients.

Materials and Methods: This study compared 30 experimental and 30 control patients, aged between 25-70, at least primary school graduate, staying in the palliative care unit. He used the unit for at least two weeks and agreed to be part of this study. While the patients in the experimental group were cared for according to the nursing care plan based on Kolcaba's comfort theory, the patients in the control group were treated with the institution's standard care plan. The results were evaluated according to the standard comfort scale and the general quality of life scale.

Study Overview

• Status: Completed
• Conditions: End of Life
• Intervention / Treatment: Other: End of Life Nursing Care Plan

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34
    • Fenerbahçe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• between 25-70 years old,
• communicable,
• at least primary school graduates,
• hospitalized in the unit for at least 2 weeks, and who agreed to participate in the study were included in the study.

Exclusion Criteria:

• All patients who did not meet the inclusion criteria and patients who were included in the study but died within 2 weeks were excluded from the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kolcaba's nursing care plan; While the patients of experimental group were cared according to the nursing care plan based on Kolcaba's comfort theory,	Other: End of Life Nursing Care Plan; the patients of experimental group were cared according to the nursing care plan based on Kolcaba's comfort theory,
No Intervention: standard care plan; the patients of control group received the standard care plan of the institution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kolcaba's comfort theory	The general comfort scale scores of patients who are cared for according to the care plan prepared according to Kolcaba's comfort theory will be higher than the control group. The scale was developed by Kolcaba in 2006. Comfort includes the subscales of relief (9 items), relaxation (9 items) and overcoming problems (10 items). In evaluating the scale consisting of positive and negative items, negative items are reverse coded and summed. The average value is found by dividing the total score obtained by the number of scale items. The lowest possible value of 1 indicates low comfort, and the highest value of 6 indicates high comfort.	2 week

Collaborators and Investigators

• Sponsor: Fenerbahce University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: nurse; Comfort; care
• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: 2016.235.IRB2.117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study data will not be used for research by other researchers. It is specific to this study. Patient data will be kept confidential.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No