The Effect of Nursing Care Based on Kolcaba's Comfort Theory on of Intensive Care Patients

NCT ID: NCT05791903

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-03

Study Completion Date

2024-06-06

Brief Summary

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Nurses aim to care for people who can no longer carry out their life activities and needs, and to ensure that they can continue to live their lives as well as possible. The aim is to improve the quality of life by making life more comfortable through care. Comfort in care means solving the patient's problems, being peaceful and content, and relieving pain/suffering. Kolcaba explained that comfort theory can be used as a guide to meet the comfort needs of individuals in the care process. The theory explains the concept of comfort as relaxation, refreshment and the ability to overcome problems (superiority). According to this theory, the nurse identifies the comfort needs of the patient and family and plans and implements interventions to meet these needs. There are no studies in the literature that have investigated the effect of nursing care based on Kolcaba's comfort theory on the comfort, satisfaction and sleep quality of ICU patients. The aim of this study is to determine the effect of nursing care based on Kolcaba's Comfort Theory on the comfort, satisfaction and sleep quality of ICU patients.

Detailed Description

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The study is a randomised controlled experimental study to determine the effect of nursing care based on Kolcaba's comfort theory on comfort, care satisfaction and sleep quality of intensive care patients. Power analysis was used to determine the sample size of the study. As a result of the power analysis, it was determined that a total of 44 participants, 22 participants in each group, should be reached to achieve 80% power with an effect size of 0.87, a margin of error of 0.05% and a confidence interval of 0.95%. To increase the reliability of the study, a total of 80 participants, 40 in the intervention group and 40 in the control group, should be included in the study, taking into account data loss. In this study, the control group will receive standard care and the intervention group will receive care based on Kolcaba's comfort theory. Data will be collected using the General Comfort Scale, the Newcastle Satisfaction Scale, the Richard Campbell Sleep Scale and the Comfort Behaviours Checklist.

Conditions

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Critical Care Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental, randomised controlled, single-blind study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
randomized

Study Groups

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Experimental Group

In the application process, individuals in the experimental group will receive care based on Kolcaba's comfort theory and comfort behaviour checklist during their stay in the ICU.

Group Type EXPERIMENTAL

Nursing Care Based on Kolcaba's Comfort Theory

Intervention Type OTHER

Comfort-orientated care

Control Group

In this study, the control group will receive standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nursing Care Based on Kolcaba's Comfort Theory

Comfort-orientated care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Volunteering to participate in the research,
* 18 years of age or older,
* Being open to communication,
* Clear state of consciousness
* Staying in the intensive care unit for at least 24 hours

Exclusion Criteria

* The patient is taking sedative medication
* Being diagnosed with a sleep disorder,
* The use of sleeping pills,
* Loss of hearing and/or vision
* Use of a hearing aid
* Dependence on mechanical ventilator
* illiteracy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuzuncu Yıl University

OTHER

Sponsor Role collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Ebubekir Kaplan

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aylin ÖZAKGÜL, PhD

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

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Van yüzüncü yıl university

Van, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Ebkrkpln

Identifier Type: -

Identifier Source: org_study_id

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