NCT06515847

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

Same day

First QC Date

July 12, 2024

Last Update Submit

July 22, 2024

Conditions

Keywords

Comfortnursecare

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Kolcaba's nursing care plan

EXPERIMENTAL

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

standard care plan

NO INTERVENTION

the patients of control group received the standard care plan of the institution

Interventions

the patients of experimental group were cared according to the nursing care plan based on Kolcaba's comfort theory,

Kolcaba's nursing care plan

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fenerbahce University

Istanbul, 34, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor , Dr Lecturer

Study Record Dates

First Submitted

July 12, 2024

First Posted

July 23, 2024

Study Start

September 1, 2017

Primary Completion

September 1, 2017

Study Completion

September 1, 2018

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Study data will not be used for research by other researchers. It is specific to this study. Patient data will be kept confidential.

Locations