Clinical trial NCT05791903: The Effect of Nursing Care Based on Kolcaba's Comfort Theory on of Intensive Care Patients
Official title: The Effect of Nursing Care Based on Kolcaba's Comfort Theory on The Comfort, Satisfaction and Sleep Quality of Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Care
Patient Satisfaction
Keywords: comfort
satisfaction
quality of sleep
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Yuzuncu Yıl University
First posted: 2023-03-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental, randomised controlled, single-blind study
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: General Comfort Scale
timeFrame: 24 hours later
measure: Comfort Behaviors Checklist
timeFrame: 24 hours later
measure: Richard-Campbell Sleep Scale
timeFrame: 24 hours later
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van yüzüncü yıl university
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Aylin ÖZAKGÜL, PhD
role: STUDY_DIRECTOR
References: