Comfort Care Bundle

Intensive care units (ICUs) are specialized units where numerous complex treatment and care procedures are applied. In these units, critically ill patients are exposed to stressful conditions and experience significant pain and other discomforts stemming from multiple internal and external factors that can alter their quality of life and trigger symptoms of post-traumatic stress disorder (PTSD). These discomforts can have various short-term or long-term consequences for patients after discharge from the ICU, such as anxiety and/or depression or PTSD, which can affect their quality of life. Therefore, knowing the negative factors affecting patient comfort in the ICU, as well as measuring patient comfort and eliminating or reducing these factors through comfort care, is crucial in reducing morbidity and mortality rates in patients. It is noteworthy that there is no specific care package in the literature aimed at improving ICU-specific comfort. Accordingly, this study aims to develop a "Comfort Care Package" to improve the comfort level of ICU patients. The research population will consist of all patients aged 18-65 years admitted to the intensive care units of Bursa City Hospital. This study will test the effect of the developed "Comfort Care Package" on the comfort level and physiological parameters of 88 ICU patients (control group=44 and study group=44) who meet the inclusion criteria and whose data were calculated using the G\*Power 3.1 program. The study will begin with the collection of data from the control group. This group will receive routine ICU care. The study group will receive the Comfort Care Package. It is anticipated that the ICU-specific comfort care package developed within the scope of this study will make significant contributions to the creation of nursing care plans aimed at increasing the comfort levels of critically ill individuals. Therefore, in patients with improved comfort, targeted recovery outcomes may increase, mortality rates may decrease, and thus public health may be sustained.

NCT Number	NCT07366021
Lead Sponsor	Akdeniz University Collaborators: Tarsus University, Halic University, Uludag University, Bursa City Hospital
Conditions	ICU, Comfort, Bundle Care, Nursing Care, Critical Illness
Enrollment	88 participants
Start Date	2025-06-01
Primary Completion	2026-06-15 (estimated)
Study Completion	2026-07-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-26