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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05791903
Study type Interventional
Source Istanbul University - Cerrahpasa (IUC)
Contact EBUBEKIR KAPLAN, PhD
Phone +905459072231
Email ebubekirkaplan31@hotmail.com
Status Recruiting
Phase N/A
Start date May 3, 2023
Completion date June 6, 2024

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